1. ELMWOOD PARK, N.J., April 1, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a COVID-19 testing agreement for players and staff, stadium employees and league staff for the 2021 Major League Baseball (MLB) season.  

    BioReference announced a COVID-19 testing agreement for the 2021 Major League Baseball (MLB) season.

    Under the agreement with MLB, BioReference will provide on-site rapid PCR point-of-care COVID-19 testing to all 30 MLB teams, leveraging Mesa Biotech's Accula System. Testing begins today, April 1, 2021 coinciding with Opening Day and will continue throughout the season.

    "With this announcement, BioReference is now supporting all five major professional men's sports leagues in the United States in safely moving forward with their seasons," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "BioReference is proud to provide COVID-19 solutions to help ensure the return to a safe, full MLB season in 2021. MLB and our other sports league clients have continued to demonstrate exemplary commitment to the health and safety of their players, employees, and stadium staff throughout the pandemic."

    "We're excited to be partnering with BioReference and look forward to their help in bringing baseball back in 2021. Safety is our top priority, and we're committed to making sure that our Clubs across the country are able to play a full season and that everyone involved stays healthy," said Jon Coyles, Vice President of Drug, Health and Safety Programs at the Office of the Commissioner of Baseball. "We're ready for a great season. Play ball!"

    To learn more about BioReference's COVID-19 testing, please visit: https://www.bioreference.com/coronavirus/.  

    About BioReference Laboratories, Inc. 

    BioReference Laboratories, Inc., is one of the largest full service specialty laboratories in the United States that gives healthcare providers and patients the power to make confident healthcare decisions. With a focus on genetics, oncology, urology and women's health, BioReference offers comprehensive test solutions and unparalleled expertise based on a 40 year legacy of proven science. The company is in-network with the largest health plans in the United States, serves approximately 19 million patients annually, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 300 M.D., D.O., Ph.D., genetic counselors and other professional clinical and scientific personnel. With a national footprint and niche market experience, BioReference provides credible and innovative solutions that meet the needs of employers, governmental agencies, educational systems, hospitals and health systems, correctional institutions, sports leagues, travel and leisure industries, and retail markets. BioReference provides industry-leading custom solutions for COVID-19, including point-of-care testing and large-scale screening programs. https://www.bioreference.com/ 

    About OPKO Health  

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com

    Contacts:

    Media Inquiries 

    Hillary Titus, 201-406-9968 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/bioreference-laboratories-expands-its-major-league-sports-relationships-with-addition-of-major-league-baseball-301260267.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  2. ELMWOOD PARK, N.J., March 26, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the expansion of its COVID-19 school testing program to support the return to in-person classroom instruction across the country.

    BioReference today announced the expansion of its COVID-19 school testing program.

    The Rockefeller Foundation announced an initiative to provide guidance on testing for K-12 schools and connect schools with laboratories and testing partners, including BioReference.

    On March 17, the Biden Administration identified COVID-19 testing in schools as a critical focus in 2021, and on Wednesday, Secretary of Education Dr. Miguel S. Cardona noted his expectation that schools to be 100% open for in-person learning in the fall. Continuing COVID-19 mitigation strategies, including testing, will play an essential role in achieving this, and helping to ensure a safe classroom environment.

    This expansion builds upon BioReference's robust expertise in school testing including specific technology developed for scheduling students/staff and reporting to parents and schools to quickly identify classes and students that may be at risk should an individual test positive. Supporting two of the largest school systems in the country, BioReference provides testing services for almost 200 schools every day and has tested nearly 400,000 public school students, principals and teachers to date.

    "As school systems continue to prioritize student safety as they work to reopen, testing will play an essential role in expediting the process and supporting a safer overall learning experience for students and their families," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "We're proud to leverage our expertise in large-scale, school testing programs to expand test offerings throughout the nation. In support of President Biden's announcement to significantly increase funding for COVID-19 school testing, BioReference is prepared to expand our successful model to multiple other school districts around the country."

    Throughout the COVID-19 pandemic, BioReference supported various government, municipalities and organizations with COVID-19 specimen collection and transportation, processing COVID-19 tests, and reporting results, having performed more than 13 million COVID-19 tests. Programs specific for school testing can include RT-PCR lab-based testing as well as rapid PCR and antigen, depending on the school and/or district needs.

    For more information on setting up a testing program for your school district, please email Ellen Beausang at .

    About BioReference Laboratories, Inc. 

    BioReference Laboratories, Inc. is the largest full service specialty laboratory in the United States that gives healthcare providers and patients the power to make confident healthcare decisions. With a focus on genetics, oncology, urology and women's health, BioReference offers comprehensive test solutions and unparalleled expertise based on a 40 year legacy of proven science. The company is in-network with the largest health plans in the United States, serves approximately 19 million patients annually, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 300 M.D., D.O., Ph.D., genetic counselors and other professional clinical and scientific personnel. With a national footprint and niche market experience, BioReference provides credible and innovative solutions that meet the needs of employers, governmental agencies, educational systems, hospitals and health systems, correctional institutions, sports leagues, travel and leisure industries, and retail markets. BioReference provides industry-leading custom solutions for COVID-19, including point-of-care testing and large-scale screening programs. https://www.bioreference.com/ 

    About OPKO Health  

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com

    Cautionary Statement Regarding Forward-Looking Statements 

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's expertise in quickly identifying classes and students that may be at risk, the role of testing in expediting and supporting a safer learning environment, BioReference's ability to successfully expand its model to multiple school districts around the country, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. 

    Contacts:

    Media Inquiries 

    Hillary Titus, 201-406-9968 

     

    School Testing Inquiries

    Ellen Beausang, 773-726-7492

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/bioreference-laboratories-expands-covid-19-school-testing-program-301256538.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  3. – If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/

    "Today's announcement is an example of our decades-long commitment to actively support the pediatric growth hormone…

    – If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/

    "Today's announcement is an example of our decades-long commitment to actively support the pediatric growth hormone deficiency community through therapeutic options that help children reach their full potential," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "If approved in the EU, somatrogon will represent an important advancement, as this long-acting, weekly treatment may reduce the burden of daily injections on children, their loved ones, and caregivers. We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency."

    "We are very appreciative of the children and their families that participated in the clinical trials, bringing us one step closer to providing a long-acting treatment option for pediatric growth hormone deficiency. If somatrogon is approved, we look forward to positively impacting the quality of life for children living with GHD," said Phillip Frost, Chairman and CEO of OPKO.

    The submission is supported by the results of a global, Phase 3 trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN® (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months. In addition, change in height standard deviation scores at 6 and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at 6 months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to the heights of their age and gender matched peers.

    Somatrogon was generally well tolerated in the study and comparable to that of somatropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

    Separately, in October 2020, Pfizer and OPKO announced findings from the C0311002 trial, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with GHD, which met its primary endpoint of improved treatment burden compared to GENOTROPIN® (somatropin) for injection administered once-daily. Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment compared to treatment with somatropin administered once-daily. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen. These data have also been submitted to the EMA.

    In January 2021, Pfizer and OPKO announced that the US Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application (BLA) for somatrogon with a target PDUFA action date of October 2021. In January 2021, a New Drug Application (NDA) was submitted to PMDA in Japan for somatrogon.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

    About the Studies

    The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study conducted in over 20 countries. This study enrolled and treated 224 pediatric patients, treatment-naïve children with growth hormone deficiency who were randomized 1:1 into two arms: somatrogon administered at a dose of 0.66 mg/kg body weight once-weekly vs GENOTROPIN® (somatropin) administered at a dose of 0.034 mg/kg body weight once daily. The primary endpoint of the trial was height velocity at 12 months. Secondary endpoints included change in height standard deviation at 6 and 12 months, safety and pharmacodynamic measures. Children completing this study had the opportunity to enroll in a global, open-label, multicenter, long-term extension study, in which they were able to either continue receiving or switch to somatrogon. Approximately 95% of the patients switched into the open-label extension study and received somatrogon treatment.

    C0311002 is a Phase 3, randomized, multicenter, open-label, crossover study assessing subject perception of treatment burden with use of somatrogon administered once-weekly versus GENOTROPIN® administered once-daily in children 3 to <18 years of age with growth hormone deficiency (GHD). The primary objective of the crossover study, which included 87 randomized and treated subjects (43 randomized to Sequence 1 [somatropin followed by somatrogon] and 44 randomized to Sequence 2 [somatrogon followed by somatropin], was to evaluate the treatment burden of a somatrogon once-weekly injection schedule and a somatropin once-daily injection schedule, as assessed by the difference in mean overall Life Interference total scores after each 12-week treatment schedule experience.

    About Somatrogon

    Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN® (somatropin)

    GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.

    Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    Pfizer Inc.: Breakthroughs that change patients' lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    DISCLOSURE NOTICE:

    The information contained in this release is as of February 26, 2021. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the EU for once-weekly treatment of pediatric patients with growth hormone deficiency, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed in any additional jurisdictions for somatrogon for the treatment of pediatric patients with growth hormone deficiency or in any jurisdictions for any other potential indications for somatrogon; whether and when the European Commission may approve the marketing authorization application for somatrogon for the treatment of pediatric patients with growth hormone deficiency and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed (including the applications pending in the U.S. and Japan), which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's or OPKO's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2020 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results" and "Cautionary Statement Regarding Forward-Looking Statements", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and, as applicable, www.pfizer.com and www.OPKO.com.

    View Full Article Hide Full Article
  4. NEW YORK, Feb. 22, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), announced its participation in the NY Forward Rapid Testing Program and opened eight locations offering COVID-19 rapid testing around New York. This program is designed to provide New Yorkers, and those visiting, with inexpensive and rapid COVID-19 testing.

    BioReference opened 8 locations for COVID-19 rapid testing around New York, through the NY Forward Rapid Testing Program

    NY Forward is a collaboration with The Empire State Development Corporation, The Real Estate Board of New York (REBNY), the City's leading real estate trade association, CVS Pharmacy, and BioReference to offer rapid COVID-19 specimen collection and testing at locations throughout New York. In the coming weeks, several hundred additional testing locations will open throughout the State.

    Using a mobile device or a computer, an individual can schedule a rapid COVID-19 test by visiting the NY Forward website, here. In following best practices, all individuals must have an appointment and will pay in advance using a cashless experience. Individuals will receive their results within approximately 30 minutes or less, which are sent via secure email, allowing them to show proof of a negative COVID-19 result.       

    Individuals who are not experiencing COVID-19 symptoms and that have not had a recent known exposure to COVID-19 may participate in this initiative by visiting participating locations and completing an eligibility questionnaire. Individuals must continue to comply with all New York Forward guidelines on reopening, including but not limited to the use of face coverings, social distancing, and other protocols. 

    Healthcare providers, businesses and pharmacies interested in participating in the NY Forward can email  for more information on how to participate or request a site near them.

    "Headquartered in the New York City metropolitan area, one of the most iconic places in the world, we are proud to work with the State of New York to support the efforts to help businesses reopen in a safe and efficient manner," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "BioReference designed this digital solution specifically so that individuals can get an affordable COVID-19 test and their results within 30 minutes."

    The following testing locations are available for the New York Forward Rapid Test Program:

    1. 6 West 52nd Street, New York, NY 10019 – one block from the 5th Avenue and 53rd Street subway station
    2. 1700 Broadway, New York, NY 10019 – one block from the 7th Avenue subway station
    3. 599 Lexington Avenue, New York, NY 10022 – one block from the 59th Street subway station
    4. CVS Pharmacy, 27 N 6th Street, Brooklyn, NY 11249 – one block from the North Williamsburg ferry terminal and four blocks from the Bedford Avenue subway station
    5. CVS Pharmacy, 30-97 Steinway Street, Astoria, NY 11103 – two blocks from the Steinway Street subway station and 46 Street subway station
    6. CVS Pharmacy, 1916 Williamsburg Road, Bronx, NY 10461 – about five blocks from the Morris Park subway station
    7. CVS Pharmacy, 2182 Broadway, New York, NY 10024 – two blocks from 79th Street subway station
    8. CVS Pharmacy, 475 6th Avenue, New York, NY10011 – two blocks from the 14th Street subway station and path station, and three blocks from the 9th Street subway station

    To schedule a rapid COVID-19 test and participate in the NY Forward Rapid Testing Program, please visit: https://nyforward.bioreference.com/

    About BioReference Laboratories, Inc. 

    BioReference Laboratories, Inc., is the largest full service specialty laboratory in the United States that gives healthcare providers and patients the power to make confident healthcare decisions. With a focus on genetics, oncology, urology and women's health, BioReference offers comprehensive test solutions and unparalleled expertise based on a 40 year legacy of proven science. The company is in-network with the largest health plans in the United States, serves approximately 19 million patients annually, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 300 M.D., D.O., Ph.D., genetic counselors and other professional clinical and scientific personnel. With a national footprint and niche market experience, BioReference provides credible and innovative solutions that meet the needs of employers, governmental agencies, educational systems, hospitals and health systems, correctional institutions, sports leagues, travel and leisure industries, and retail markets. BioReference provides industry-leading custom solutions for COVID-19, including point-of-care testing and large-scale screening programs. https://www.bioreference.com/ 

    About OPKO Health 

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com

    Cautionary Statement Regarding Forward-Looking Statements 

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing and participation in the NY Forward collaboration, whether we are able to consistently deliver results within 30 minutes, the accuracy of the test, the availability of testing and the role and value of the information provided and its impact on decisions, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. 

    Contacts:

    Media Inquiries 

    Hillary Titus, 201-406-9968 

     

    NY Forward Program Inquiries

    Meghan Ziobro, 401-230-7941

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/new-york-state-partners-with-bioreference-laboratories-to-spearhead-the-ny-forward-covid-19-rapid-test-program-to-help-reopen-the-new-york-economy-301232502.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  5. MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended December 31, 2020.

    Business Highlights

    • BioReference Laboratories' volume in the fourth quarter of 2020 increased 170% compared to 2019. COVID-19 PCR testing volume increased 24% over the third quarter of 2020. During the fourth quarter of 2020, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and currently has the capacity to process more than 100,000 PCR tests per day. In addition, BRL performed approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.

      BRL continues to provide…

    MIAMI, Feb. 18, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended December 31, 2020.

    Business Highlights

    • BioReference Laboratories' volume in the fourth quarter of 2020 increased 170% compared to 2019. COVID-19 PCR testing volume increased 24% over the third quarter of 2020. During the fourth quarter of 2020, BioReference Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR tests and currently has the capacity to process more than 100,000 PCR tests per day. In addition, BRL performed approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.



      BRL continues to provide innovative solutions to the COVID-19 testing needs of physicians, health systems, long-term care facilities, governments, schools, employers, professional sports teams, entertainment venues, and the general public through relationships with Rite-Aid and CVS. In January 2021, BRL announced COVID-19 testing agreements for players and officials, as well as team and league staff for the 2020-2021 seasons for the National Basketball Association (NBA) and National Hockey League. BRL is also supporting the COVID-19 testing needs of the Winter X Games in Aspen, U.S. Soccer's Women's and Men's National Teams and the NBA G League in Orlando.

    • BRL introduced Scarlet Health™ to expand digital health access. In January 2021, BRL launched Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Backed by BRL's national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet Health delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when phlebotomy and other specimen collection services are needed.



    • GeneDx added repeat expansion analysis genetic tests. GeneDx launched several new genetic tests, including repeat expansion analysis for spinocerebellar ataxia, Friedreich ataxia and other forms of hereditary ataxias. With these additions, GeneDx has created a comprehensive and affordable offering that covers the vast majority of genes involved with pediatric-onset and adult-onset ataxias.



    • Regulatory submission from OPKO's commercial partner, Pfizer, accepted in the U.S. and filed in Japan for somatrogon to treat pediatric patients with growth hormone deficiency. The U.S. Food and Drug Administration (FDA) accepted for filing the initial Biologics License Application for somatrogon, a long-acting human growth hormone intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency. The target Prescription Drug User Fee Act action date for decision by the FDA is October 2021. In addition, a New Drug Application was submitted to the Ministry of Health, Labour, and Welfare in Japan for somatrogon. Pfizer remains on schedule with respect to its regulatory submission for marketing approval of somatrogon in Europe in the first quarter of this year.



    • RAYALDEE has received marketing authorizations in 11 European countries. Vifor Fresenius Medical Care Renal Pharma, OPKO's commercial partner for RAYALDEE in Europe, has received marketing authorizations for RAYALDEE for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency in 11 European countries, adding Spain, Portugal, Italy and Switzerland to previously announced approvals in the United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the Netherlands. Market launch of RAYALDEE in authorized countries is expected later this year.

    Fourth Quarter Financial Results

    • Net income for the fourth quarter of 2020 was $32.3 million, or $0.05 per diluted share, compared with a net loss of $112.4 million, or $0.18 per share, for the comparable period of 2019. Consolidated revenues for the fourth quarter of 2020 were $494.6 million compared with $224.3 million for the comparable period of 2019. 



    • Diagnostics: Revenue from services in the fourth quarter of 2020 increased to $457.9 million from $177.9 million in the prior-year period, due to COVID-19 testing volume, partially offset by lower clinical test volume reflecting the negative impact of the pandemic and by reduced clinical and genomic test reimbursement. Total costs and expenses were $388.0 million in the fourth quarter of 2020 compared with $223.4 million in the fourth quarter of 2019, resulting in operating income of $69.9 million compared with an operating loss of $45.4 million in the 2019 period. The increase in operating income of $115.3 million reflects increased volumes as a result of COVID-19 testing and a non-cash impairment charge of $38.7 included in the 2019 period for goodwill and intangible assets related to the acquisition of Claros.



    • Pharmaceuticals: Revenue from products in the fourth quarter of 2020 was $30.8 million compared with $32.0 million in the fourth quarter of 2019, primarily attributable to a decline in sales of Rayaldee, which were negatively impacted by challenges in onboarding new patients due to the intensified COVID-19 pandemic, offset by an increase in sales from OPKO Chile. Total prescriptions of Rayaldee for the fourth quarter of 2020 decreased to approximately 15,000, compared with approximately 17,900 for the fourth quarter of 2019. Revenue from the transfer of intellectual property was $5.9 million in the fourth quarter of 2020 compared with $14.4 million in the fourth quarter of 2019, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $45.7 million in the fourth quarter of 2020 compared with $103.2 million in the prior-year period, which included a non-cash impairment charge of $53.1 million for goodwill and intangible assets related to the acquisitions of CURNA and Transition Therapeutics. The operating loss was $9.0 million in the fourth quarter of 2020 compared with $56.8 million in the fourth quarter of 2019.



    • Cash and equivalents: Cash, cash equivalents and marketable securities were $72.2 million as of December 31, 2020. In addition, the Company has availability under its present line of credit with JP Morgan of $57.6 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update, discuss fourth quarter financial results and answer questions during a conference call and live audio webcast at 4:30 p.m. Eastern time today, February 18, 2021. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, the demand for testing, our capacity for testing, the impact of COVID-19 on all of our businesses, positively and negatively, our ability to expand our capacity should there be additional demand, the availability of resources, including labor, equipment and supplies, to meet demand for testing and the potential impact on us should these resources be constrained, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether RAYALDEE prescriptions will increase, our ability to market and sell any of our products in development, GeneDx's test offerings and the effectiveness and utility of its ataxias tests, BioReference's Scarlet Health mobile service, the availability of and demand for the service, whether the service and the integrated platform will function or perform as designed, the role and value of the service to patients and healthcare providers and whether the demand for at home health care will continue or increase as anticipated, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer, Vifor and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications proposed or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in millions)

    Unaudited

     As of
     December 31,

    2020
     December 31,

    2019
    Assets:       
    Cash, cash equivalents and marketable securities$72.2  $85.5 
    Other current assets 451.0   238.5 
    Total Current Assets 523.2   324.0 
    In-process Research and Development and Goodwill 1,270.8   1,262.1 
    Other assets 679.1   723.2 
    Total Assets$2,473.1  $2,309.3 
            
    Liabilities and Equity:       
    Current liabilities$375.5  $249.1 
    Convertible Notes 222.0   211.2 
    Deferred tax liabilities, net 137.2   118.7 
    Other long-term liabilities, principally contract liabilities, leases, contingent consideration and lines of credit 66.8   115.5 
    Total Liabilities 801.5   694.5 
    Equity 1,671.6   1,614.8 
    Total Liabilities and Equity$2,473.1  $2,309.3 

    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in millions, except share and per share data)

    Unaudited

     For the three months ended

    December 31,
     For the year ended

    December 31,
      2020   2019   2020   2019 
    Revenues           
    Revenue from services$457.9  $177.9  $1,262.2  $716.4 
    Revenue from products 30.8   32.0   120.0   112.2 
    Revenue from transfer of intellectual property 5.9   14.4   53.2   73.3 
    Total revenues 494.6   224.3   1,435.4   901.9 
    Costs and expenses           
    Cost of revenues 318.7   142.3   894.4   572.5 
    Selling, general and administrative 101.8   79.1   355.6   343.3 
    Research and development 17.5   23.0   75.3   117.9 
    Contingent consideration (5.3)  (14.8)  (4.0)  (14.9)
    Amortization of intangible assets 12.6   15.4   56.4   64.8 
    Asset impairment charges 0.0   91.8   0.0   92.4 
    Total Costs and expenses 445.3   336.8   1,377.7   1,176.0 
    Operating Income (loss) 49.3   (112.5)  57.7   (274.1)
    Other income and (expense), net (3.4)  4.0   (9.0)  (30.8)
    Income loss before income taxes and investment losses 45.9   (108.5)  48.7   (304.9)
    Income tax provision (13.6)  (3.4)  (17.6)  (7.1)
    Income (loss) before investment losses 32.3   (111.9)  31.1   (312.0)
    Loss from investments in investees (0.0)  (0.5)  (0.5)  (2.9)
    Net Income (loss)$32.3  $(112.4) $30.6  $(314.9)
    Loss per share, basic and diluted$0.05  $(0.18) $0.05  $(0.53)
    Weighted average common shares outstanding, basic and diluted 640,590,427   622,474,281   640,655,290   595,454,394 


    Primary Logo

    View Full Article Hide Full Article
  6. MIAMI, Feb. 03, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers…

    MIAMI, Feb. 03, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended December 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, February 18, 2021. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on February 18th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 8597848. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 4Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 4Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 8597848.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100



    Primary Logo

    View Full Article Hide Full Article
  7. MIAMI, Jan. 28, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced today that its partner, Pfizer Japan Inc., submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare in Japan for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, conducted in subjects with pediatric GHD, in which the efficacy and safety of somatrogon administered once weekly were compared with GENOTROPIN® (somatropin), a recombinant human growth hormone for injection, administered once daily. In both…

    MIAMI, Jan. 28, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced today that its partner, Pfizer Japan Inc., submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare in Japan for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, conducted in subjects with pediatric GHD, in which the efficacy and safety of somatrogon administered once weekly were compared with GENOTROPIN® (somatropin), a recombinant human growth hormone for injection, administered once daily. In both studies, somatrogon showed comparable efficacy to GENOTROPIN for the primary endpoint of annual height velocity at 12 months of treatment. Somatrogon was generally well tolerated in both studies, with comparable safety to that of GENOTROPIN administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

    In 2014, Pfizer Inc. and OPKO Health, Inc. entered into a worldwide agreement for the development and commercialization of somatrogon. Under the agreement, OPKO is responsible for conducting the clinical program, and Pfizer is responsible for registering and commercializing the product.

    About the Japan Phase 3 Study

    The Phase 3 study of somatrogon in 44 treatment-naïve Japanese pre-pubertal children with pediatric GHD was a 12-month, open-label, randomized, active-controlled, parallel-group study of the efficacy and safety of weekly somatrogon compared to recombinant human growth hormone (r-hGH), GENOTROPIN® (somatropin) for injection treatment administered once-daily. Eligible patients were randomized in a 1:1 ratio to receive either once-weekly somatrogon or GENOTROPIN administered once-daily (reference therapy, 0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week). To obtain pharmacokinetic information of three different weekly doses in Japanese pediatric GHD patients, somatrogon treated patients received 0.25 mg/kg/week for 2 weeks, followed by 0.48 mg/kg/week for 2 weeks followed by 0.66 mg/kg/week for the remaining 46 weeks. Somatrogon was administered subcutaneously using a single patient use, multi-dose, disposable, pre-filled pen, the same pen used in the global study, while GENOTROPIN was administered using approved commercial products in Japan.

    About Somatrogon

    Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN

    GENOTROPIN (somatropin) is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding whether the Ministry of Health, Labour, and Welfare ("Ministry") may approve the NDA for somatrogon for the treatment of pediatric patients with growth hormone deficiency, whether the Ministry will be satisfied with the results from our clinical study, whether the Ministry will interpret the clinical trial data in a similar manner to us, whether, if approved, somatrogon will be commercially successful in Japan for its approved indication, that the market for somatrogon exists, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, and positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100



    Primary Logo

    View Full Article Hide Full Article
  8. GAITHERSBURG, Md., Jan. 26, 2021 /PRNewswire/ -- GeneDx, Inc., a wholly owned subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today launched several new genetic tests, including repeat expansion analysis for spinocerebellar ataxia (SCA), Friedreich ataxia, and other common forms of hereditary ataxias. With these additions, GeneDx has created a comprehensive and affordable offering that covers the vast majority of genes involved with pediatric-onset and adult-onset ataxias.

    GeneDx launched new tests, including repeat expansion analysis for SCA, Friedreich ataxia, and other common ataxias.

    Ataxia refers to clumsiness or a loss of balance and coordination that is not due to muscle weakness. While there are a number of factors that can cause ataxia, approximately 60-70% of ataxia cases have an underlying genetic cause.1,2 Genetic testing for adult-onset ataxia is currently limited to a small number of diagnostic laboratories, most of which only offer a portion of the relevant testing, have long turnaround times, and high out of pocket costs to patients.

    Most types of adult onset hereditary ataxia are caused by nucleotide repeat expansions within the deoxyribonucleic acid (DNA) and are usually identified by specialized testing. The remaining types of hereditary ataxia may be caused by single nucleotide variants (SNVs) and copy number variants (CNVs) that can be identified by sequencing and deletion/duplication testing.

    "Individuals with ataxia need more diagnostic testing options for genetic forms of the disease," said Amanda Lindy, Ph.D., FACMG, Director of Neurogenetics for GeneDx. "Historically, genetic testing for ataxia has been limited, creating a barrier for some individuals to obtain testing. GeneDx's expanded test offerings provide the flexibility of ordering single or multi-gene repeat expansion analyses, concurrently or reflexively, with a phenotypically driven Xpanded panel or an exome. Thus covering the broadest possible differential, delivering more answers to patients and their families, and enabling precision medical management."

    "GeneDx has a deep clinical knowledge of the ataxias and related movement disorders, gained from our long history and industry-leading development of neurogenetic testing," said Sean Hofherr, Ph.D., FACMG, Executive Vice President and CLIA Laboratory Director of GeneDx. "Expanding our menu to include adult-onset ataxias, in addition to the existing portfolio for childhood-onset ataxias, underscores GeneDx's commitment to rare disease identification as well as filling an unmet need for patients and providers, alike."

    About GeneDx, Inc.

    GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding GeneDx's test offerings and the effectiveness and utility of its ataxias tests, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    References:

    1. Fogel, Brent L et al. "Exome sequencing in the clinical diagnosis of sporadic or familial cerebellar ataxia." JAMA neurology vol. 71,10 (2014): 1237-46. doi:10.1001/jamaneurol.2014.1944
    2. Németh, Andrea H et al. "Next generation sequencing for molecular diagnosis of neurological disorders using ataxias as a model." Brain: a journal of neurology vol. 136,Pt 10 (2013): 3106-18. doi:10.1093/brain/awt236.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-genedx-adds-repeat-expansion-analysis-genetic-tests-for-diagnosis-of-spinocerebellar-ataxia-sca-friedreich-ataxia-and-other-common-forms-of-hereditary-ataxia-301214623.html

    SOURCE GeneDx, Inc.

    View Full Article Hide Full Article
  9. ELMWOOD PARK, N.J., Jan. 26, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced COVID-19 testing agreements for players and officials, as well as team and league staff for the 2020-2021 seasons for the National Basketball Association (NBA) and National Hockey League (NHL).

    BioReference executes COVID-19 testing for NBA, NHL, US National Soccer Teams, Winter X Games and NBA G League.

    For the 2020-21 NBA season, BioReference has been providing testing services, utilizing PCR and rapid diagnostics, at the 30 NBA team facilities in 28 cities across the U.S. BioReference previously supported the NBA's 2019-20 season restart.

    Under an agreement with the NHL, BioReference will provide COVID-19 testing to players, coaches, staff and officials, which includes COVID-19 PCR laboratory-based diagnostics, and rapid diagnostics to the 24 U.S.-based teams.

    In addition, BioReference is currently supporting the Winter X Games in Aspen, U.S. Soccer's Women's and Men's National Teams and the NBA G League in Orlando.

    "Continuing to support the NBA in the 2020-21 season, showcases lessons learned from Orlando, and leverages emerging technology to support the current season and the overall partnership we have built throughout the COVID-19 pandemic," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Utilizing similar detailed and systematic protocols, we have been selected to support the NHL, U.S. Soccer, Winter X Games and NBA G League. It is a privilege for BioReference to support professional sports, underscoring our commitment to develop customized solutions that assist Americans in getting back to the workplace safely and provide the nation access to entertainment."

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference developed and offers test services that yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the role and value of testing, whether the results from our previous testing program can be successfully duplicated or deployed in other settings or venues, whether implementing the same strategies or other strategies will be successful in preventing the spread of the disease or providing safety against infection to the participants, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, and strategies. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-team-up-with-the-national-basketball-association-and-national-hockey-league-to-provide-players-and-staff-with-covid-19-testing-301214617.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  10. ELMWOOD PARK, N.J., Jan. 13, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today introduced Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Scarlet has been designed similarly to tools consumers use daily, in order to provide ease-of-use and ubiquitous conveniences. 

    BioReference introduced Scarlet, an in-home, fully integrated digital platform providing access to diagnostic services.

    Backed by BioReference's national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when…

    ELMWOOD PARK, N.J., Jan. 13, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today introduced Scarlet Health, an in-home, fully integrated digital platform providing access to on-demand diagnostic services. Scarlet has been designed similarly to tools consumers use daily, in order to provide ease-of-use and ubiquitous conveniences. 

    BioReference introduced Scarlet, an in-home, fully integrated digital platform providing access to diagnostic services.

    Backed by BioReference's national presence and infrastructure, with laboratory facilities and professionals across the country, Scarlet delivers an innovative, flexible, mobile alternative to traditional patient service centers or other draw locations when phlebotomy and other specimen collection services are needed. 

    Patients will no longer need to travel for laboratory services. Healthcare providers will secure vital diagnostic information about patients reliably, quickly and easily to enable a faster diagnosis.  

    To use Scarlet's convenient, secure and safe approach to mobile specimen collection services, patients will obtain a link after visiting or connecting virtually with their healthcare provider. After confirming the services needed, a patient will verify their identity and schedule a date and time, and choose their preferred location (i.e., at their office or home) for a qualified healthcare professional to collect their test specimen. Patients will then receive real-time updates and relevant information, such as learning how to prepare for the visit or track the healthcare professional's arrival. Specimens will be sent to BioReference for testing, and the results will be securely shared online with the patient and their ordering healthcare provider.  

    "Scarlet reimagines the delivery of health care, creating an accessible, consumer-centric approach to the way patients receive laboratory services," said Richard Schwabacher, Senior Vice President of Digital Health and Chief Digital Officer for BioReference Laboratories. "Scarlet is the first of many digital health advances at BioReference that aim to increase flexibility and convenience for patients. We're proud to bring this kind of innovation and technology to patients and are looking forward to expanding access to critical health care needs with Scarlet."  

    Investment in telemedicine has more than doubled in the last year to $1.6 billion, a dramatic acceleration attributable to the COVID-19 pandemic and the growing demand for the tools and flexibility that digital health offers.1 Scarlet provides a much-needed service that is efficient, secure, convenient, flexible, digitally enabled and easy to use, providing access to a variety of tests, from COVID-19 to chronic conditions, and more.  

    "The future of health care is at home. We're helping to make in-home health care real for millions of Americans by bringing diagnostic services directly to the patient," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "According to PwC Health Research Institute Health's 2020 executive survey, 40% of healthcare providers cited laboratory challenges as a concern with growing telehealth programs. By adding just a few key strokes to what healthcare providers are already doing, Scarlet improves and encourages patient-centered health care, utilizing a similar on-demand format that patients use every day from the comfort of their homes. With Scarlet, BioReference removes a disconnect between telemedicine and traditional health care, and revolutionizes how healthcare is provided." 

    Scarlet services are currently available in select markets. For more information on Scarlet, visit www.scarlethealth.com.    

    About BioReference Laboratories, Inc. 

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference offers test services that yield high-quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com

    About OPKO Health  

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com

    Cautionary Statement Regarding Forward-Looking Statements 

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, particularly statements regarding BioReference's Scarlet Health mobile service, the availability of and demand for the service, whether the service and the integrated platform will function or perform as designed, the role and value of the service to patients and healthcare providers and whether the demand for at home health care will continue or increase as anticipated, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. 

    References: 

         1.    PwC Health Research Institute Health's 2020 executive survey 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-introduces-scarlet-health-an-in-home-diagnostic-service-to-expand-digital-health-access-301207796.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  11. NEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO" or the "Company"), today announced that it sent a letter to the Company's Board of Directors (the "Board") on December 18, 2020 regarding what we believe is the dubious 4Q'20 guidance provided by management on October 29, 2020. Sian wants all analysts and stockholders to be aware that we believe OPKO's previously issued guidance is misleading. We are calling on OPKO to confirm whether it still stands by its projections or agrees with our estimates.

    Please be advised that OPKO's management will be hosting one-on-one meetings with investors and presenting at the 39…

    NEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO" or the "Company"), today announced that it sent a letter to the Company's Board of Directors (the "Board") on December 18, 2020 regarding what we believe is the dubious 4Q'20 guidance provided by management on October 29, 2020. Sian wants all analysts and stockholders to be aware that we believe OPKO's previously issued guidance is misleading. We are calling on OPKO to confirm whether it still stands by its projections or agrees with our estimates.

    Please be advised that OPKO's management will be hosting one-on-one meetings with investors and presenting at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13th at 3:40 p.m. Eastern. We encourage analysts and investors to review our estimates against OPKO's guidance and ask management whether it stands by the Company's 4Q'20 guidance. Given that we believe Sian correctly predicted OPKO's 3Q'20 financial results before they were announced, we remain very confident that our current analysis of OPKO's 4Q'20 financials is accurate.

    The below table outlines guidance OPKO provided on its October 29, 2020 conference call compared to the conservative guidance estimates Sian released on November 12, 2020. Our analysis leads us to believe that OPKO under-guided 4Q'20 growth by 26.3%.

     EBITDASerology Tests PCR TestsCOVID-19 Tests*
    OPKO 4Q'20 Guidance$20-30 million300,0002.9-3.5 million3.2-3.8 million
    Sian's Estimate$30-40 million300,0003.9-4.5 million4.2-4.8 million

    *OPKO's "COVID-19 testing guide" includes Serology and PCR Tests.

    The day after OPKO announced its projections, the stock price dropped 20%. In stark contrast, OPKO's stock price increased 25% in the weeks after we released our 4Q'20 estimates on November 12, 2020.

    In our White Paper on OPKO's fundamental value, we refute OPKO's guidance in detail and provide, in our view, a more accurate guide using public data, the Company's commentary, public competitors, competitors in the supply chain, government statistics and independent market analysis. We view OPKO's 4Q'20 guidance as unfathomable and urge analysts and investors to ask management today whether the Company:

    1. Disagrees with our analysis and stands by its original 4Q'20 guidance, or

    2. Agrees with our analysis and admits its original 4Q'20 guidance was incorrect.

    In closing, Sian remains open and willing to engage with OPKO regarding its ideas for high-potential opportunities in the marketplace. Unfortunately, it seems management is no longer interested in engaging with us after ignoring our latest attempts to try to work collaboratively to drive stockholder value. We find it troubling that management would seemingly rather spend investor resources fighting one of its largest stockholders instead of resuming productive discussions with us.

    For those interested in learning more about the value opportunity at OPKO, visit www.SianCapital.com/Resources. We have provided Sian's projected 2021 guidance for the Company. Despite recent events, we remain encouraged by the numerous growth prospects for OPKO and its stockholders in 2021.

    About Sian Capital

    Founded by veteran portfolio manager Anish Monga, Sian Capital, LLC is a New York-based asset management firm that employs a focused, event-driven investment approach. Sian's unique mix of cross-sector experience and activism expertise enables it to identify and invest in what are often overlooked or under-covered investment opportunities.

    Contacts

    Profile

    Greg Marose / Charlotte Kiaie

    /



    View Full Article Hide Full Article
  12. Aviceda has assembled a renowned team of scientific entrepreneurs and biopharma senior executives to spearhead ongoing development efforts of pipeline candidates and help the company continue to explore growth opportunities.

    Aviceda Therapeutics, a late-stage, pre-clinical biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to manipulate the innate immune system and chronic, non-resolving inflammation, is announcing the composition of the Executive Team that will guide the company through ongoing development of breakthrough, first-in-class therapeutics and continued growth opportunities as a business entity.

    Serving in key leadership roles on Aviceda's Executive Leadership…

    Aviceda has assembled a renowned team of scientific entrepreneurs and biopharma senior executives to spearhead ongoing development efforts of pipeline candidates and help the company continue to explore growth opportunities.

    Aviceda Therapeutics, a late-stage, pre-clinical biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to manipulate the innate immune system and chronic, non-resolving inflammation, is announcing the composition of the Executive Team that will guide the company through ongoing development of breakthrough, first-in-class therapeutics and continued growth opportunities as a business entity.

    Serving in key leadership roles on Aviceda's Executive Leadership Team will be:

    • Mohamed Genead, MD, CEO & President,
    • David Callanan, MD, Chief Medical Officer,
    • Derek Kunimoto, MD, JD, Chief Operating Officer,
    • Michael Tolentino, MD, Chief Technology Officer, and
    • Christopher Scott, PhD, Chief Scientific Officer.

    "Aviceda is extremely proud of the world-class team of internationally renowned experts we have assembled to guide the company in the next phases of growth. In addition to offering keen scientific insight into product development, each member of the Executive Team also brings with them previous experience in key leadership positions in the pharmaceutical industry. Being able to tap into this knowledge base will undoubtedly pay huge dividends as Aviceda pursues an aggressive but realistic growth and product development strategy," said Dr. Genead, who is a Co-Founder of Aviceda.

    A serial life-sciences entrepreneur, senior innovative biopharma executive, inventor, and consultant to many ophthalmic biotechnology companies and healthcare venture firms, Dr. Genead is widely regarded as a global executive and senior leader with 20-plus years' experience in pharmaceutical drug and business development with execution from discovery to late development and commercial phases. He has played key roles in executing global approvals and launches and driving sales growth in country, regional and global development positions together with direct reporting teams.

    Dr. Genead previously served as Chief Medical Officer and Executive Vice-President for GenSight Biologics where he led the clinical team to multiple phase I-III trials leveraging a disruptive ocular gene therapy and optogenetics platforms in patients with retinal degenerative diseases. Prior to GenSight, Dr. Genead was Biogen's Head of Ophthalmology and Retina Gene Therapy. Dr. Genead has also held leadership positions with Allegro Ophthalmics, where he led the global clinical development teams for the Risuteganib (anti-integrin) platform, and Allergan, where he was Global Medical Director and Clinical Team Lead for Retina Therapeutic area. Dr. Genead is a Co-founder of several start-ups, has been instrumental in the raising of over $500M in venture and institutional capital for numerous life sciences biotech companies and is currently a board member of several ophthalmic organizations and scientific advisory boards. Dr. Genead is a board-certified ophthalmologist/retina specialist by training, having completed a vitreoretinal fellowship at the Department of Ophthalmology and Visual Sciences of the University of Illinois in Chicago and Medical College of Wisconsin. He has served as a principal Investigator with a proven record of success in developing and launching global blockbuster therapeutics. He was the primary and key author for numerous peer-reviewed manuscripts in high impact factor scientific journals (more than 100 manuscripts and presentations) focusing on clinical research and novel therapeutics.

    Dr. Callanan is a board-certified ophthalmologist, a clinical Professor at the University of Texas Southwestern Medical School in Dallas, Texas and surgeon with Texas Retina Associates, specializing in vitreoretinal diseases including uveitis, diabetic retinopathy and age-related macular degeneration.

    Dr. Callanan earned his medical degree at the University of Iowa College of Medicine and completed his ophthalmology residency at Parkland Memorial Hospital, University of Texas Southwestern Medical Center. He received a National Research Service Award from the National Institutes of Health for the study of Ocular Immunology with Dr. Jerry Niederkorn. He was a Heed Ophthalmic Foundation Fellow at the prestigious Bascom Palmer Eye Institute in Miami, Florida. He completed fellowships in medical retina with legendary Dr. J. Donald M. Gass and vitreoretinal surgery with the Bascom Palmer faculty. Dr. Callanan also received additional training in uveitis with Dr. Robert Nussenblatt at the National Eye Institute in Bethesda, over 60 peer reviewed articles and several book chapters, Dr. Callanan is widely regarded as a respected leader in his field. Throughout his career he has actively conducted clinical research and has played an instrumental role in several ophthalmic drug approvals. In addition to his clinical and academic responsibilities, Dr. Callanan also serves on the board of directors of the Retina Foundation of the Southwest and is a member of numerous professional and honorary societies, including the American Academy of Ophthalmology, The Association for Research in Vision and Ophthalmology, The Macula Society, The American Uveitis Society, and the American Society of Retina Specialists, among others.

    "I am thrilled to join Aviceda at an exciting time for the company and its portfolio of pipeline candidates. Glyco-immune therapeutics offers the prospect of a truly transformational approach to treating a variety of underserved immune mediated inflammatory conditions that do not have adequate therapeutic options. While our immediate focus will be on ophthalmic conditions, there is tremendous potential to improve treatment options for a wide assortment of conditions affecting the innate immune system," said Dr. Callanan.

    Dr. Kunimoto, who is a co-Founder of Aviceda, holds a medical degree with honors from Harvard Medical School and a law degree with honors from Oxford University, which he attended on a Rhodes Scholarship. He was a medicine intern at Massachusetts General Hospital and completed his residency at Wills Eye Hospital in Philadelphia, where he served as co-chief resident. Dr. Kunimoto was recognized as a Heed and Michaels Fellow. He worked as a consultant with the management consultancy, McKinsey & Co. Dr. Kunimoto has authored numerous peer-reviewed publications, two major ophthalmology textbooks, and has been invited to speak at ophthalmology conferences, both nationally and internationally. Dr. Kunimoto has been very active in the clinical research of retinal diseases, acting as Investigator or Principal Investigator in over 150 global clinical trials. A recipient of numerous honors for academic and research achievements, Dr. Kunimoto served as Managing Partner of Retinal Consultants of Arizona, where he lead efforts to grow the practice to 35 locations, develop a nutraceutical franchise, and establish an Aviation Department for transportation and patient coverage at outlying satellite offices. He also served as Manager of the Retina Research Institute. Dr. Kunimoto is a founding member and served as Founding President of the Vit-Buckle Society, served as Chair of the Medical Student Governing Council in the Massachusetts Medical Society, and as a member on the Council on Constitution and Bylaws of the American Medical Association. Outside of medicine, Dr. Kunimoto serves on the Board of Directors of the Association of American Rhodes Scholars.

    Prior to graduating with a medical degree from the University of Massachusetts, Dr. Tolentino performed research on retinal degeneration at the Schepens Eye Research Institute and the Berman Gund Lab (both at Harvard Medical School), as well as the National Eye Institute. After Medical School, Dr. Tolentino did a post-doctoral angiogenesis research fellowship in the lab of Dr. Judah Folkman, where he helped develop a cancer/xenograft model to screen for angiogenic inhibitors, work that demonstrated the role of Vascular Endothelial Growth Factor (VEGF) in macular degeneration, diabetic retinopathy and vein occlusion. During this time he purified Bevacizumab (Avastin), a drug designed for oncologic applications, and demonstrated intravitreal application could inhibit ocular neovascularization, a discovery that led to the eventual development of anti-VEGF therapeutics for retinal disease. After finishing his Ophthalmology Residency, Dr. Tolentino joined the retina and molecular ophthalmology faculty at the University of Pennsylvania, where he ran a lab funded by the National Institutes of Health working on gene, cell and RNAi therapy. Among his many accomplishments is the invention of a new class of gene silencing molecules called small interfering RNA (siRNA) against anti-angiogenic targets. He has 3 issued patents on the composition and methods of use of these molecules in vertebrate organisms for treating neovascular diseases. The discovery of siRNA and its mechanisms in invertebrate worms resulted in the Nobel prize in Medicine for Craig Mello and Andrew Fire in 2006. Dr. Tolentino co-founded and served as the interim CEO/CSO for Acuity Pharmaceuticals, where he was able to herald the first siRNA therapeutic into human clinical trials. Acuity eventually merged with Exegenic Inc to form OPKO health (NYSE:OPK), a publicly traded biopharmaceutical company. Over the course of his career, Dr. Tolentino has been very active in the clinical research of retinal diseases, acting as principal investigator in over 150 clinical trials that led to multiple global approvals for retinal therapeutics. He has authored over 100 publications and delivered over 200 international lectures. He has served as a consultant/scientific advisor for numerous pharma/biotech companies.

    Prof. Scott, Aviceda Scientific Co-Founder, is Director of the Patrick G Johnston Centre for Cancer Research and Cell Biology at Queen's University Belfast. He is internationally renowned for his work in development of novel approaches in the field of antibody and nanomedicine-based therapies for the treatment of cancer and other conditions. Prof. Scott has a background in both the pharmaceutical industry and academia and was a founding scientist of Fusion Antibodies Plc. Research in his laboratory is funded by agencies such as Medical Research Council, UK charities and various industrial sources. He also held a Royal Society Industrial Fellowship with GSK from 2012 to 2015 and won the Vice Chancellor's Prize for Innovation in 2015 with his group's work on developing a novel Siglec targeting nanomedicine for the treatment of sepsis and other inflammatory conditions.

    About Aviceda Therapeutics

    ​Founded in 2018 and based in Cambridge, Massachusetts, ​Aviceda Therapeutics is a ​late-stage, pre-clinical ​biotechnology company​ with a mission to develop the next generation of glyco-immune therapeutics (GITs) utilizing a proprietary technology platform to modulate the innate immune system and chronic, non-resolving inflammation. Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians and drug developers to tackle devastating ocular and systemic degenerative, fibrotic, oncologic and immuno-inflammatory diseases. At Aviceda, we exploit a unique family of receptors expressed on all innate immune cells and their associated glycobiological interactions to develop transformative medicines. Combining the power of our biology with our innovative cell-based high-throughput screening platform and proprietary nanoparticle technology, we can modulate the innate immune response specifically and profoundly. Aviceda is developing a pipeline of GITs that are delivered via biodegradable nanoparticles and which safely and effectively target numerous immune-inflammatory conditions. Aviceda's lead ophthalmic optimized nanoparticle, as an intravitreal formulation, AVD-104, is being developed to target various immune system responses that contribute to the pathology associated with age-related macular degeneration (AMD).

    View Full Article Hide Full Article
  13. MIAMI, Jan. 05, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in the 39th Annual J.P. Morgan Healthcare Conference being held virtually on January 11-14, 2021. Management will be hosting one-on-one meetings with investors and will be presenting on Wednesday, January 13th at 3:40 p.m. Eastern time.

    The presentation will be webcast live and available for replay in the Investors section of OPKO Health's website and accessible by clicking here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise…

    MIAMI, Jan. 05, 2021 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in the 39th Annual J.P. Morgan Healthcare Conference being held virtually on January 11-14, 2021. Management will be hosting one-on-one meetings with investors and will be presenting on Wednesday, January 13th at 3:40 p.m. Eastern time.

    The presentation will be webcast live and available for replay in the Investors section of OPKO Health's website and accessible by clicking here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100



    Primary Logo

    View Full Article Hide Full Article
  14. ELMWOOD PARK, N.J., Jan. 4, 2021 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced the results of COVID-19 molecular PCR tests for public schools throughout New York City's boroughs, with a positivity rate of 0.47 percent.

    BioReference announced the COVID-19 PCR test results for NYC's public schools, with a positivity rate of 0.47.

    "These results indicate that an active surveillance system can be successfully developed and implemented in a highly complex environment such as the nations' largest public school system," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Testing is one component of the multiple mitigation steps developed by New York City, which include real time results reporting to the city situation room, closure protocols, social distancing, masks and ventilation improvements. These measures taken by the city and the teachers' union resulted in a very low COVID-19 rate of infection within the school system for those individuals tested by BioReference. We are proud to be one of the partners that helped in this effort to have children return to school and continue to learn in a safe environment."

    On September 2, BioReference began working with New York City to COVID-19 PCR test principals, teachers and staff in preparation for a safer back-to-school environment. Prior to the start of the 2020-2021 school year, BioReference tested 8,913 individuals, with an average turnaround time of less than 24 hours. 

    Subsequently, BioReference and New York City expanded the school testing program to include students on October 9. Sixty-four teams visited almost 200 schools per day, having tested 209,790 individuals in more than 1,200 schools with an average turnaround time of less than 38 hours. Among the total individuals tested, 975 (0.47%) were positive for COVID-19.

    COVID-19 positivity rates by borough were; Manhattan: 0.37%, Brooklyn: 0.45%, Queens: 0.38%, Staten Island: 0.52% and Bronx: 0.71%. Interestingly, the rate for students and teachers, principals and staff were similar and very low (less than 1%).

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference developed and offers test services that yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing, the availability of testing and the role and value of the information provided and its impact on decisions, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-reports-results-of-the-largest-covid-19-public-school-testing-program-nationwide-301200323.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  15. - If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210104005200/en/

    The target Prescription Drug User Fee Act (PDUFA) action date for decision by the FDA is in October 2021. Somatrogon is an investigational new biologic product that is glycosylated…

    - If approved, somatrogon will serve as a once-weekly treatment option –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210104005200/en/

    The target Prescription Drug User Fee Act (PDUFA) action date for decision by the FDA is in October 2021. Somatrogon is an investigational new biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule.

    "The FDA's filing acceptance is an encouraging step closer to our goal of providing a long-acting, once-weekly therapy for pediatric patients living with GHD. If approved, somatrogon could help reduce the burden of daily growth hormone injections on children, their loved ones, and caregivers," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "For 35 years, Pfizer has been committed to improving the outcomes of patients living with GHD, and somatrogon is another example of how we are working to positively impact quality of life and treatment compliance to help ensure those patients can reach their full potential."

    The submission is supported by the results of a global Phase 3 trial evaluating the safety and efficacy of somatrogon administered once weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN® (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months. The top-line results from the study demonstrated the least square mean was higher in the somatrogon group (10.12 cm/year) than in the somatropin group (9.78 cm/year); the treatment difference (somatrogon – somatropin) in height velocity (cm/year) was 0.33 with a two-sided 95% confidence interval of the difference (-0.39, 1.05). In addition, change in height standard deviation scores at 6 and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at 6 months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to the heights of their age and gender matched peers.

    Somatrogon was generally well tolerated in the study and comparable to that of somatropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

    About the Study

    The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study conducted in over 20 countries. This study enrolled and treated 224 pediatric patients, treatment-naïve children with growth hormone deficiency who were randomized 1:1 into two arms: somatrogon administered at a dose of 0.66 mg/kg body weight once-weekly vs GENOTROPIN® (somatropin) administered at a dose of 0.034 mg/kg body weight once daily. The primary endpoint of the trial was height velocity at 12 months. Secondary endpoints included change in height standard deviation at 6 and 12 months, safety and pharmacodynamic measures. Children completing this study had the opportunity to enroll in a global, open-label, multicenter, long-term extension study, in which they were able to either continue receiving or switch to somatrogon. Approximately 95% of the patients switched into the open-label extension study and received somatrogon treatment.

    About Somatrogon

    Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN® (somatropin)

    GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    Important GENOTROPIN® Safety Information

    • Growth hormone should not be used to increase height in children after the growth plates have closed.
    • Growth hormone should not be used in patients with diabetes who have certain types of diabetic retinopathy (eye problems).
    • Growth hormone should not be used in patients with cancer or who are being treated for cancer. Growth hormone deficiency can be caused by brain tumors. So, the presence of these brain tumors should be ruled out before treatment is started. Growth hormone should not be used if it is shown that a previous brain tumor has come back or is getting larger.
    • Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure.
    • Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.
    • GENOTROPIN should not be used by patients who have had an allergy or bad reaction to somatropin or any of the other ingredients in GENOTROPIN.
    • Some patients have developed diabetes mellitus while taking GENOTROPIN. Dosage of diabetes medicines may need to be adjusted during growth hormone treatment. Patients should be watched carefully if growth hormone is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.
    • In childhood cancer survivors, treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors. This risk may be higher in patients who were treated with cranial radiation. Also, patients and their doctors should check regularly for any skin changes.
    • A small number of patients treated with growth hormone have had increased pressure in the brain. This can cause headaches and problems with vision. Treatment should be stopped and reassessed in these patients. Patients with Turner syndrome and Prader-Willi syndrome may be at higher risk of developing increased pressure in the brain.
    • Thyroid function should be checked regularly during growth hormone therapy. Thyroid hormone replacement therapy should be started or adjusted if needed.
    • Patients treated with growth hormone should be checked regularly if they are receiving standard hormone replacement therapy to treat a lack of more than one hormone.
    • In children experiencing rapid growth, curvature of the spine may develop or worsen. This is also called scoliosis. Patients with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy.
    • In children experiencing rapid growth, limping or hip or knee pain may occur. If a child getting growth hormone therapy starts to limp or gets hip or knee pain, the child's doctor should be notified and the child should be examined.
    • Growth hormone should only be used during pregnancy if clearly needed. It should be used with caution in nursing mothers because it is not known whether growth hormone is passed into human milk.
    • Use a different place on the body each day for growth hormone injections. This can help to prevent skin problems such as lumpiness or soreness.
    • Some cases of pancreatitis (inflamed pancreas) have been reported rarely in children and adults receiving growth hormone. There is some evidence that there is a greater risk of this in children than in adults. Literature suggests that girls who have Turner syndrome may have a greater risk of pancreatitis than other children taking growth hormone. In any child who develops lasting, severe abdominal pain, pancreatitis should be considered.
    • In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash. Other side effects were fat loss, headache, blood in the urine, low thyroid activity, and mildly increased blood sugar.
    • In studies of GENOTROPIN in children born SGA, side effects included temporarily elevated blood sugar, increased pressure in the brain, early puberty, abnormal jaw growth, injection site reactions, growth of moles, and worsening of scoliosis (curvature of the spine).
    • Deaths have been reported with the use of growth hormone in children with Prader-Willi syndrome. These children were extremely overweight, had breathing problems, and/or lung infection. All patients with Prader-Willi syndrome should be examined for these problems. They should also establish healthy weight control.
    • In studies of GENOTROPIN in children with PWS, side effects included fluid retention, aggressiveness, joint and muscle pain, hair loss, headache, and increased pressure in the brain.
    • Turner syndrome patients taking growth hormone therapy may be more likely to get ear infections. This is also called otitis media.
    • In studies of GENOTROPIN in children with Turner syndrome, side effects included flu, throat, ear, or sinus infection, runny nose, joint pain, and urinary tract infection.
    • In studies of GENOTROPIN in children with ISS, side effects included respiratory illnesses, flu, throat infection, inflammation of the nose and throat, stomach pain, headaches, increased appetite, fever, fracture, mood changes, and joint pain.
    • Women who are taking estrogen by mouth may take GENOTROPIN. They may need a larger dose of growth hormone.
    • GENOTROPIN may be taken by the elderly. Elderly patients may be more likely to have side effects with growth hormone therapy.
    • In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation. Usually these side effects did not last long and depended on the dose of GENOTROPIN being taken.
    • GENOTROPIN cartridges contain m-Cresol and should not be used by patients allergic to it.
    • A health care provider will help you with the first injection. He or she will also train you on how to inject GENOTROPIN.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For the full Prescribing Information for GENOTROPIN, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=577.

    GENOTROPIN Indications and Usage in the U.S.

    GENOTROPIN is a prescription product for the treatment of growth failure in children:

    • Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).
    • With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor.
    • Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA).
    • With a genetic condition called Turner syndrome (TS).
    • With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height, and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause.

    GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.

    Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    Pfizer Inc.: Breakthroughs that change patients' lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    PFIZER DISCLOSURE NOTICE:

    The information contained in this release is as of January 4, 2021. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the U.S. for once-weekly treatment of pediatric patients with growth hormone deficiency, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any additional jurisdictions for somatrogon for the treatment of pediatric patients with growth hormone deficiency or in any jurisdictions for any other potential indications for somatrogon; whether and when the FDA may approve the BLA for somatrogon for the treatment of pediatric patients with growth hormone deficiency and whether and when regulatory authorities in any jurisdictions may approve any such other applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's or OPKO's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2019 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results" and "Cautionary Statement Regarding Forward-Looking Statements", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and, as applicable, www.pfizer.com and www.OPKO.com.

    View Full Article Hide Full Article
  16. ORCHARD PARK, N.Y., Dec. 31, 2020 /PRNewswire/ -- Buffalo Bills, 2020 AFC East Division Champions, and BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced they will be performing fan testing for the AFC Divisional Wild Card playoff game at Bills Stadium in Orchard Park.

    Through New York State, the Bills have been granted permission to host fans at their home Wild Card game that will be played on Jan. 9 or 10. All fans will be required to obtain a negative COVID-19 PCR laboratory-based test result within 72 hours of the game through the NFL's testing partner, BioReference, in order to attend the game. Fans that purchase a ticket will be given a BioReference URL to select a testing time at Bills Stadium, two or three days prior to game day.

    "BioReference has been helping our players, coaches and staff stay safe all season," said Kim Pegula, Bills Owner and President. "We have no doubt they will help create a safe environment for our long awaited home playoff game. We are pleased to expand our partnership to bring fans back into the stadium."

    "The Bills, New York State and BioReference are committed to providing a safe environment so that fans can enjoy the playoff game," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "BioReference has led the way in providing customized large scale COVID-19 screening programs to organizations and municipalities across the country. Fan testing is the next natural step in helping Americans attend and enjoy live sporting and entertainment events."  

    "Bills fans have waited decades in order to attend a home playoff game and we have worked to build an innovative pilot program to make that happen safely," Governor Cuomo said. "All season long, the Bills' stellar play has captured a certain energy and charisma that is undoubtedly infectious, but we all need to be smart. We're in control of our destiny and how we act is going to determine what comes next. So while this is a time for excitement and celebration, it's critical that everyone follow the guidelines and practice the safe behaviors we know work. If everyone does their part, I believe this pilot will be successful. Go Bills!"  

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions, and medical groups. BioReference developed and offers test services that yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology, and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing, the availability of testing and the role and value of the information provided and its impact on decisions, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/buffalo-bills-and-opko-healths-bioreference-laboratories-initiate-the-first-large-scale-mandatory-covid-19-fan-testing-program-301199641.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  17. MIAMI, Dec. 21, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced the appointment of Roger Medel, M.D. as an independent member of its Board of Directors, effective December 18, 2020. With this appointment, the OPKO Health Board has 11 Directors, including seven independent Directors.

    "We are delighted to welcome Roger to the OPKO Health Board of Directors," stated Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. "Roger brings a unique perspective based on his vast experience as a physician and as an executive growing a successful healthcare services organization. We look forward to Roger's valuable insight and deep knowledge as we continue to execute OPKO's strategy."

    Dr. Medel is the co-founder…

    MIAMI, Dec. 21, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced the appointment of Roger Medel, M.D. as an independent member of its Board of Directors, effective December 18, 2020. With this appointment, the OPKO Health Board has 11 Directors, including seven independent Directors.

    "We are delighted to welcome Roger to the OPKO Health Board of Directors," stated Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO Health. "Roger brings a unique perspective based on his vast experience as a physician and as an executive growing a successful healthcare services organization. We look forward to Roger's valuable insight and deep knowledge as we continue to execute OPKO's strategy."

    Dr. Medel is the co-founder of MEDNAX, Inc., a national health solutions partner comprised of the nation's leading providers of physician services, and has served as a Director of MEDNAX since 1979. In addition, he served as MEDNAX's President from its founding until May 2000, then again from March 2003 until May 2004, and as its Chief Executive Officer since its founding until December 2002 then again from March 2003 until his retirement in July 2020. Under his leadership, the company grew from one small group of neonatologists managing care in one local hospital, to a group of more than 1,200 neonatologists and more than 1,000 advanced practice nurses that manages neonatology departments, including neonatal intensive care units in approximately 400 hospitals. Additionally, MEDNAX expanded into the largest group of pediatric cardiologists, pediatric intensivists and maternal fetal specialists. The company currently cares for approximately 25% of the sick and premature babies born annually in the United States.

    Dr. Medel has served as a member of the Board of Trustees of the Dana Farber Cancer Institute, Inc. since January 2016. In addition, he was a member of the Board of Trustees of the University of Miami from January 2004 to February 2012, and from June 2006 to April 2009 served on the Board of Directors of MBF Healthcare Acquisition Corp. Dr. Medel actively participates as a member of several medical and professional organizations.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100



    Primary Logo

    View Full Article Hide Full Article
  18. Believes OPKO Should Promptly Distribute FDA-Reviewed Rayaldee to Help Treat COVID-19 in the U.S. and Europe

    Highlights the Opportunity Being Squandered by Dr. Frost and the Board as Europe Prepares to Distribute 10 Million Doses of a Less Effective Alternative to Rayaldee

    NEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder with beneficial ownership of approximately 3% of OPKO Health, Inc.'s (NASDAQ:OPK) ("OPKO" or the "Company") outstanding common stock, today sent a letter to OPKO's Board of Directors highlighting the urgent need for the Company to act swiftly to distribute Rayaldee – an effective drug shown to help treat COVID-19 – across the U.S…

    Believes OPKO Should Promptly Distribute FDA-Reviewed Rayaldee to Help Treat COVID-19 in the U.S. and Europe

    Highlights the Opportunity Being Squandered by Dr. Frost and the Board as Europe Prepares to Distribute 10 Million Doses of a Less Effective Alternative to Rayaldee

    NEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder with beneficial ownership of approximately 3% of OPKO Health, Inc.'s (NASDAQ:OPK) ("OPKO" or the "Company") outstanding common stock, today sent a letter to OPKO's Board of Directors highlighting the urgent need for the Company to act swiftly to distribute Rayaldee – an effective drug shown to help treat COVID-19 – across the U.S. and Europe.

    Over the past week, we have had conversations with members of the United States Congress, those living in European countries, and the world's foremost infectious disease specialists. We look forward to sharing more information regarding how you can encourage your Congressperson to help your loved ones. In the meantime, visit www.SianCapital.com/Resources to learn more about OPKO and Rayaldee.

    The full text of the letter is included below.

    ***

    VIA E-MAIL

    November 20, 2020

    The Board of Directors

    OPKO Health, Inc.

    4400 Biscayne Blvd.

    Miami, Florida 33137

    Dear Chairman Frost and Members of the Board of Directors (the "Board"):

    As of this week, a quarter of a million people have died in the U.S. from COVID-19. New York City is closing public schools amid rising cases, hospitals and first responders across the country are overwhelmed with sick patients, and experts predict that the U.S. could soon be reporting more than 2,000 deaths per day – matching or exceeding our spring peak.1 As Dr. Anthony Fauci recently commented, "we are in for a world of hurt."

    With more than 11.5 million confirmed cases in the U.S., we find our entire nation focused on a singular question: when will we be able to effectively treat patients with the deadly virus?

    Sian Capital, LLC (together with its affiliates, "Sian" or "we") was extremely dismayed to learn that OPKO Health, Inc. ("OPKO" or the "Company") has a viable solution at its fingertips, yet for reasons unclear to us, has withheld its science from millions of afflicted citizens in the U.S. and abroad. As a substantial investor in OPKO, we believe the Board has not only a fiduciary duty, but a humanitarian duty to distribute Rayaldee to those in need. There is no reason that so many Americans should continue dying without having the opportunity to access potential curative drugs. In this letter, we outline how Rayaldee could save countless lives while also unlocking tremendous revenues for OPKO right away.

    How Rayaldee Could Save Countless Lives Amidst the COVID-19 Pandemic

    As early as 2008 and as recently as 2016, leading scientists predicted that our population's widespread deficiency in vitamin D could lead to a global pandemic. There is growing evidence today that COVID-19 patients who are deficient in vitamin D are more likely to experience serious illness, severe complications and increased risk of death. Unfortunately, raising your vitamin D levels is not as easy as taking over-the-counter supplements from your local drug store.

    Instead, evidence shows we can fight and prevent COVID-19 through the administration of a vitamin D prohormone, Calcifediol, which naturally interacts with the body to create the necessary levels of pure 25(OH)D serums. Calcifediol is the active ingredient in OPKO's homegrown drug Rayaldee, which is typically used to treat Chronic Kidney Disease. When treating patients afflicted with both Chronic Kidney Disease and COVID-19, it was discovered that Rayaldee was fighting the virus, as well. This discovery and additional anecdotal evidence led the Food and Drug Administration ("FDA") to give Rayaldee a high safety indication and fast-track Rayaldee's phase 2 trial on June 1, 2020 for treatment of mild to moderate COVID-19.2 The FDA required only a 4-week trial and 160 participants to be treated with the drug, in stark contrast to Pfizer's vaccine trial, which required nearly 45,000 participants. Further, the FDA required that just two primary endpoints be met to pass the trial: 1) Rayaldee raise 25(OH)D levels to between 50ng/ML and 100 ng/ML, and 2) Rayaldee outperform the placebo group.

    Rayaldee quickly proved to be effective, with treatment indicating that a daily dose of 60 mcg of Rayaldee is the only one of the four treatment regimens tested that reliably raises 25(OH)D serum totals to the range of 50 to 100 ng/ML passing the first FDA endpoint. In a separate simultaneous trial in Spain, patients in the Calcifediol (Rayaldee) group had a 96% effectiveness rate, with just 2% of patients hospitalized with zero fatalities – compared to those in the placebo group where 50% were hospitalized with a death rate of 7.7%.3

    In spite of Rayaldee's encouraging trial evidence and the highest safety indication the FDA can give, OPKO's Board and management team are seemingly withholding this effective drug from the U.S. and European populace. Because Calcifediol is an American drug owned by OPKO, both U.S. and European governments cannot utilize Rayaldee unless OPKO sells it to them.4 This is especially troubling given that our European neighbors have already passed legislation requiring the distribution of ~15 million doses of a crude, less effective alternative to Rayaldee, in an attempt to replicate Rayaldee's protective benefits, to millions of their most vulnerable populations next month. It is well known that the elderly, the sick and those in nursing homes are disproportionately dying at high mortality rates. We believe European countries would likely administer many prescriptions if OPKO were to offer Rayaldee to them instead of obfuscating its benefits and failing to reach out to England, Scotland and many other countries who have already approved millions of doses.

    With over 1.34 million deaths globally and the death toll steadily rising, we question what could possibly motivate OPKO to sit on science that could potentially save so many lives?

    How OPKO Could Unlock Significant Value for Shareholders by Distributing Rayaldee

    It is painfully obvious to Sian that in addition to disregarding its ability to save lives, OPKO is squandering an incredible value opportunity by withholding Rayaldee. In 2019, OPKO sold only ~55,000 scripts of Rayaldee for ~$30 million. If OPKO allowed European countries to purchase the already approved ~15 million doses, even at a 90% discount to its selling price, OPKO could receive over $850 million. Much more importantly, at the current death rate, it could save 100,000 lives over the four-month program enacted by European countries.

    Despite the current dysfunction of our political climate, it's our view that the U.S. should follow Europe's lead by ordering doses for 12 million of our most vulnerable citizens. Though just 1% of U.S. citizens live in nursing homes, nursing home deaths account for over 20% of our daily death rates. We believe OPKO should similarly discount its selling price of Rayaldee by 90%, which could unlock $3 billion in value and save tens of thousands of American lives.

    Beyond selling Rayaldee to the U.S. government, we believe OPKO has a humanitarian duty to distribute Rayaldee across the pond, where a European citizen is dying every 17 seconds from COVID-19.5 When lending assistance to the Europeans during World War II, FDR famously said that when your neighbor's house is on fire, you don't haggle over the price of a garden hose. Putting aside economics, from a humanitarian perspective, it is apparent to us that OPKO should move quickly to distribute its valuable drug on an international scale, even if it is at an 90% discount.

    Over the last few weeks, the governments of England, Spain, Scotland, Wales and Ireland have all committed to helping their most vulnerable, citing studies that indicate Rayaldee is the best way to do that. We urge you to share one of the only drugs that appears to help treat COVID-19. We believe you have a humanitarian and fiduciary duty to do so.

    "If there's a child on the south side of Chicago who can't read, that matters to me, even if it's not my child. If there's a senior citizen somewhere who can't pay for their prescription, who has to choose between medicine and the rent, that makes my life poorer - even if it's not my grandparent. If there's an Arab-American or Mexican-American family being rounded up by John Ashcroft without benefit of an attorney or due process, I know that that threatens my civil liberties. And I don't have to be a woman to be concerned that the Supreme Court is trying to take away a woman's right, because I know that my rights are next. It is that fundamental belief - I am my brother's keeper, I am my sister's keeper - that makes this country work."

    -- Barack Obama, 2004

    Sincerely,

    Anish Monga

    Sian Capital LLC

    ***

    About Sian Capital

    Founded by veteran portfolio manager Anish Monga, Sian Capital, LLC is a New York-based asset management firm that employs a focused, event-driven investment approach. Sian's unique mix of cross-sector experience and activism expertise enables it to identify and invest in what are often overlooked or under-covered investment opportunities.

    Contacts

    Profile

    Greg Marose / Charlotte Kiaie

    /

    1 The New York Times: A quarter of a million people have died in the U.S. from Covid-19. (November 19, 2020).

    2 https://www.opko.com/investors/news-events/press-releases/detail/394/fda-authorizes-opko-health-clinical-trial-evaluating.

    3 Journal of Steroid Biochemistry and Molecular Biology; The Guardian: Covid: UK government requests guidance on vitamin D use (November 14, 2020).

    4 To be clear, we are not implying that Vifor Pharma (SWX: VIFN), the holder of the license to sell Rayaldee in Europe in exchange for royalties to OPKO, has not already begun negotiations with these European countries. Our letter references only OPKO, who ultimately makes the decision, regardless if Vifor were (hypothetically) negotiating with these countries.

    5 The Washington Post: Someone in Europe is dying every 17 seconds from covid-19, WHO says (November 19, 2020).



    View Full Article Hide Full Article
  19. Highlights that Just Two Weeks after Sian Capital Sent Its 220 Demand Letter to OPKO, the Company has Agreed to Release A Subset of the Documents Requested, Which We Believe Will Validate our Valuation Assertions

    Announces OPKO Has Agreed to Enact Important Governance Enhancements to Protect Stockholders, Including the Addition of a New, Independent Director and Further Stockholder-Friendly Governance Changes by January 2021

    Sets the Record Straight Regarding the Apparent Falsehoods and Misrepresentations OPKO is Peddling to Stockholders, Including Management's Assertion that Its Ownership of &gt;40% Renders Stockholders Powerless

    Urges the Board to Formally Announce and Initiate a Credible Strategic Review to Help Enact Change, Restore Stockholder

    Highlights that Just Two Weeks after Sian Capital Sent Its 220 Demand Letter to OPKO, the Company has Agreed to Release A Subset of the Documents Requested, Which We Believe Will Validate our Valuation Assertions

    Announces OPKO Has Agreed to Enact Important Governance Enhancements to Protect Stockholders, Including the Addition of a New, Independent Director and Further Stockholder-Friendly Governance Changes by January 2021

    Sets the Record Straight Regarding the Apparent Falsehoods and Misrepresentations OPKO is Peddling to Stockholders, Including Management's Assertion that Its Ownership of >40% Renders Stockholders Powerless

    Urges the Board to Formally Announce and Initiate a Credible Strategic Review to Help Enact Change, Restore Stockholder Confidence and Identify Steps for Delivering the Value Long-Suffering Stockholders Deserve

    NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder with beneficial ownership of approximately 3% of OPKO Health, Inc.'s (NASDAQ:OPK) ("OPKO" or the "Company") outstanding common stock, today issued the below letter to stockholders. Recently, Sian issued a presentation outlining paths to enhanced value creation at OPKO and posted other relevant materials at www.siancapital.com/resources.

    November 12, 2020

    Fellow Stockholders,

    Sian Capital, LLC (together with its affiliates, "Sian" or "we") has been overwhelmed by the positive investor response to our October 2020 presentation that outlines several viable paths to unlocking the tremendous value trapped within OPKO Health, Inc.'s ("OPKO" or the "Company") underperforming stock. After receiving messages from more than 400 supportive stockholders over the past two weeks, one thing has become crystal clear to us: investors are fed up with leadership's self-serving decisions and believe now is the time to pursue the many high-potential opportunities that exist across the industry.

    We believe the public market does not fully appreciate OPKO's prized assets because it has lost confidence in the Company's management and Board of Directors (the "Board"). It appears these leaders are either unable or unwilling to address the array of governance, financial and strategic issues that continue to depress the Company's stock price. Moreover, it has recently come to our attention that OPKO's representatives are going so far as to attempt to dissuade stockholders from supporting change at the Company and making baseless claims regarding Sian and the Company's governance. For this reason, we want to expose OPKO's misinformation campaign and refute its recent effort to miscast Sian and our value-enhancing ideas.

    FACT: OPKO's Investor Relations Team is Waging a Misinformation Campaign Against Sian

    Despite Sian frequently engaging with Chairman and CEO Dr. Phillip Frost, Executive Vice President and director Steven Rubin, OPKO's investor relations team, as well as other members of OPKO senior management to discuss paths to unlock value for stockholders over the past six months, OPKO's investor relations team is now falsely claiming to stockholders that they have "never heard of Sian" in an apparent attempt to discredit us and our research. The reality is OPKO proactively reached out to Sian within 24 hours of the release of our public presentation to continue our dialogue. In spite of the Company's misinformation campaign, investors have been studying our materials, resulting in positive feedback and support from analysts who follow OPKO closely. Just today at the H.C. Wainwright 6th Annual Israel Virtual Conference, an analyst asked multiple questions regarding some of the very same strategic options we have urged OPKO to examine. The analyst specifically asked if OPKO would consider splitting its Pharma and Laboratory division since neither is getting the value it deserves, to which the Company responded that they are exploring this and "may in fact do that," especially since the Pharma division will be self-funding once hGH and Rayaldee royalties begin shortly and is something they intend to look at going forward. The analyst further asked about rumors they independently heard of regarding acquiror interest, to which the Company responded, "we engage in strategic decisions [consistently] and at this time won't comment." Several savvy investors highlighted these comments to us today noting they signal the Company seems willing to take the steps Sian has outlined. We believe investors can now clearly see the direct path to unlock the value that long-suffering investors deserve.

    FACT: The Delaware Court of Chancery and OPKO's Board have Approved the Institution of Several Corporate Governance Changes by January 2021

    Stockholders should know that within just two weeks of Sian sending its 220 Demand Letter to OPKO, and just one week after it was publicly disclosed on October 29th by press release and Sian Capital's website,1 the OPKO Board and the Delaware Court of Chancery approved a settlement that requires OPKO to implement certain important governance enhancements no later than January 31, 2021. These include but are not limited to:

    • The Mandatory Appointment of a New Independent Director to the Board – OPKO is required to add a new, independent director, specifically required to have less than 5% stock ownership (to prevent further concentration of ownership) and no previous employment or ties with current management.



    • The Nominating Committee of the Board This committee may be the only Committee to recommend new Board members. The Chairman is also disallowed from participating on the Nominating Committee, preventing further hand-picked directors by the Chairman.



    • Stockholder Consultation Required for Director SelectionThe Nominating Committee is required to consider the input from significant stockholders, which must be done explicitly in good faith, including on issues of director independence, qualifications and selection.



    • Lead Independent Director – Mandatory checks have been put in place delivering greater power to the Lead Independent Director: (i) at each Board meeting there shall be a separately convened session of non-management Board directors, and (ii) the Lead Independent Director has sole approval over the schedule of all Board meetings, and is required to be consulted on the agenda of each Board meeting, as well as all information sent to the Board.



    • Independent Investment Committee – A new Independent Investment Committee ("IIC") is required to consist of exclusively independent directors who shall be given sole authority, in its discretion, to hire its own independent advisors when making investment decisions on minority investments. Members of the IIC are required to recuse themselves if they or any family members have a material investment, or affiliation, with a potential transaction partner.2

    The full list of corporate governance enhancements OPKO is required to undertake can be found on Sian's website here.

    ____________________

    1https://siancapital.com/wp-content/uploads/2020/10/2020-10-21-Ltr-OPKO-Health-Inc.-re-Del-220-Demand_5577783.pdf

    2 In re Opko Health, C.A. No. 2018-0740-SG (2020).

    OPKO has Agreed to Send Sian Requested Documents – In addition to these enhancements, the Company has agreed to send Sian a subset of the documents we requested in our 220 Demand Letter, which we believe will affirm our fundamental analysis. Predictably, OPKO has denied our request for certain other documents, which we find suspicious because this information would help verify various allegations we learned from in-depth interviews conducted during our extensive due diligence. We will continue to work to obtain these documents on behalf of all OPKO stockholders.

    FACT: Dr. Frost and the Board Have a Fiduciary Duty to Act in the Best Interests of Stockholders

    Dr. Frost's aggressive stock purchases this year have caused Company insiders to exceed a 40% ownership position, which is a key threshold we have been eyeing for quite some time. The rise of insider control was a factor we were watching closely and conscious of well before deciding to publicize our view of the value opportunity at OPKO, as it not only verified our thesis that the Company's fundamentals are set to inflect in over the next year, but also provided us with a path to help ensure improved governance changes would be made. As a result of Dr. Frost and the Board's actions, we believe Dr. Frost is now considered a "Controlling Stockholder" and the OPKO Board is "Conflicted," as both are specifically defined under Delaware law. As we describe in our Corporate Governance White Paper, the simultaneous presence of a "Controlling Stockholder" and "Conflicted Board" in the same public company actually has specific ramifications under Delaware law, precisely because of the enhanced potential for misuse of power. In fact, in these situations, Delaware law actually imposes stricter duties on the stockholder and the Board to protect minority stockholders in these situations from abuses of power.

    FACT: Filings Show That OPKO Leaders Could be Personally Liable for Breaches of Their Fiduciary Duties, Leaving Them Highly Vulnerable and Exposed to Potential Litigation

    Through our conversations with fellow stockholders, we found that it was largely unknown that the Company's history of egregious violations has left its Board with the possibility that no insurance company will cover them, and if they do, it could be costly for inadequate and limited coverage, thereby leaving them potentially personally liable for any breach – a risk we cannot fathom any Board member would take. We also note that the Company's insurance premiums nearly doubled over 2019, costing stockholders an astounding $25 million while they suffered incredible financial loses. We believe upon reading our Corporate Governance White Paper, investors will have a sharply different view of stockholders' ability to effect change than the one espoused by the Company over the past several days.

    FACT: There is a Clear Path to Unlock Value for OPKO Stockholders

    Many stockholders agree with our view that OPKO is deeply undervalued, worth at least 3x its current stock price, and that the multiple paths we have outlined for maximizing that value are viable. Sian believes that our significant alignment with stockholders and strong track record helping companies optimize returns for investors will serve us in helping reverse the billions of dollars in destruction of value at OPKO. Given that OPKO's stock continues to trade at a significant discount, we believe the Board should initiate a formal strategic review process to determine how the Company can realize the true potential of its assets. Recent feedback has shown that a critical mass of stockholders agree it is time for OPKO's leaders to honor their fiduciary duties and quickly move to deliver the value that long-suffering investors deserve by announcing and initiating a credible review process. Further, we believe multiple potential suitors have come forward, unsolicited, to discuss partnerships, acquisitions, royalty agreements and other value-enhancing alternatives. We urge stockholders to ask OPKO themselves: has the Company received interest in its assets? We believe the answer will be telling.

    We encourage investors to closely read the three White Papers we have posted to our website. These contain further details on the Company's true fundamental value, which should be read in conjunction with Sian's previous investor presentation, an examination on corporate governance under Delaware law, and examples of how we can continue to enact change. These papers also include short commentary on the election results and Pfizer's tepid vaccine announcement last week, which we believe have only made the industry tailwinds more pronounced.

    In the weeks ahead, we will continue to communicate frequently and transparently with you regarding the best path forward for OPKO. We encourage you to engage with us on a one-to-one basis in the meantime by e-mailing .

    Sincerely,

    Anish Monga

    Founder and Managing Partner

    Sian Capital LLC

    About Sian Capital

    Founded by veteran portfolio manager Anish Monga, Sian Capital, LLC is a New York-based asset management firm that employs a focused, event-driven investment approach. Sian's unique mix of cross-sector experience and activism expertise enables it to identify and invest in what are often overlooked or under-covered investment opportunities.

    Contacts

    Profile

    Greg Marose / Charlotte Kiaie

    /   

     

    View Full Article Hide Full Article
  20. MIAMI, Nov. 11, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in three upcoming virtual investor conferences.

    • H.C. Wainwright 6th Annual Israel Virtual Conference, November 12, 2020. Management will participate in a fireside chat on Thursday, November 12th at 9:00 a.m. ET and will be available for one-on-one meetings.

    • Jefferies 2020 Virtual London Healthcare Conference, November 17-19, 2020. Management will deliver a company presentation on Wednesday, November 18th at 10:15 a.m. ET and will be available for one-on-one meetings. A live and archived webcast of the presentation will be available in the Investors section of OPKO's website here.

    • Piper Sandler 32nd Annual Virtual

    MIAMI, Nov. 11, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in three upcoming virtual investor conferences.

    • H.C. Wainwright 6th Annual Israel Virtual Conference, November 12, 2020. Management will participate in a fireside chat on Thursday, November 12th at 9:00 a.m. ET and will be available for one-on-one meetings.



    • Jefferies 2020 Virtual London Healthcare Conference, November 17-19, 2020. Management will deliver a company presentation on Wednesday, November 18th at 10:15 a.m. ET and will be available for one-on-one meetings. A live and archived webcast of the presentation will be available in the Investors section of OPKO's website here.



    • Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3, 2020. Management will participate in a fireside chat and will be available for one-on-one meetings. A replay of the fireside chat will be available in the Investors section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100

     

    or

    Bruce Voss, 310-691-7100

     

    Primary Logo

    View Full Article Hide Full Article
  21. Issues Presentation Outlining Viable Paths to Unlocking OPKO's Intrinsic Value, Which is ~3x the Company's Current Market Capitalization Based on its Diagnostic and Pharmaceutical Assets

    Releases Letter to OPKO Demanding Books and Records After Amassing Serious Concerns About Boardroom Conflicts and the Company's Ability to Objectively Assess Alternatives

    Underscores that Sian has the Ability to take Appropriate Action in Accordance with Delaware Law, Which Offers Specific Protections from Conflicted Boards and Controlling Stockholders as Outlined in our Presentation

    NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO…

    Issues Presentation Outlining Viable Paths to Unlocking OPKO's Intrinsic Value, Which is ~3x the Company's Current Market Capitalization Based on its Diagnostic and Pharmaceutical Assets

    Releases Letter to OPKO Demanding Books and Records After Amassing Serious Concerns About Boardroom Conflicts and the Company's Ability to Objectively Assess Alternatives

    Underscores that Sian has the Ability to take Appropriate Action in Accordance with Delaware Law, Which Offers Specific Protections from Conflicted Boards and Controlling Stockholders as Outlined in our Presentation

    NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Sian Capital, LLC (together with its affiliates, "Sian" or "we"), a sizable stockholder of OPKO Health, Inc. (NASDAQ:OPK) ("OPKO" or the "Company"), today released a detailed presentation outlining viable paths to unlocking the Company's tremendous upside potential following years of significant underperformance and value destruction. In addition, Sian released a demand letter that it has sent OPKO pursuant to Delaware Law. These materials are available at https://siancapital.com/resources/.

    Anish Monga, Sian's Managing Partner and Portfolio Manager, commented:

    "OPKO's stockholders have been forced to endure billions of dollars in losses due to, in our view, leadership's missteps, poor communication and self-interested decisions. Rather than take prompt steps to increase stockholder value, we contend that Chairman and Chief Executive Officer Dr. Phillip Frost and the Company's leadership team have ignored high-potential opportunities in the marketplace and demonstrated an inability to unlock the true value of the Company's prized assets. In addition, we believe Dr. Frost and his associates have given disinterested stockholders cause for significant concern by filing for approval under the Hart–Scott–Rodino Antitrust Improvements Act to increase their ownership to more than 50% and by purchasing stock (at all-time lows) frequently from January through June. It is time for OPKO's leadership to honor its fiduciary duties and quickly move to deliver the value that long-suffering investors deserve.

    "Sian has spent months conducting industry research, holding conversations with ex-employees and consultants, and engaging with potential acquirers for OPKO's presently undervalued assets. We have provided OPKO with a roadmap for success and tried to sustain a productive dialogue. It is time for a viable, value-enhancing roadmap to be implemented at OPKO."

    A summary of Sian's detailed presentation is as follows:

    We believe BioReference ("BRL") is worth $3 billion to $6 billion given its true annual earnings power is between $300 million and $400 million.

    • COVID-19 and serology testing revenue in 3Q'20 will be over $200 million while BRL's base business has recovered more rapidly than Quest and LabCorp.
    • BRL's 4Q COVID-19 revenue will increase >20% to >$250 million.
      • BRL's base business will grow ~10-15% for the foreseeable future. GeneDx, Oncology and Women's Health are the three fastest growing divisions in the industry, which comprise 40% of BRL's business growing an average of 15%. If the remainder of the business grows just half of that, 10%-15% is highly achievable.
      • BRL has significantly increased insurance coverage, recently becoming one of just five labs, and one of just three national labs with scale, to be selected for United Healthcare's Network. BRL also recently won the in-network contract for Humana and Blue Cross Blue Shield in Texas.
        • Quest has named a similar opportunity as $4 billion total available market of which they assume 25% share, anticipating $1 billion growth in revenue. If BRL achieved just half of that, this would unlock an additional $500 million in revenue (more than 50% of BRL's entire revenue base in 2019).
        • BRL has signed multi-year significant strategic partnerships with, among others, Pediatrix Medical Group, Inc., a 2,200 nationwide physician network, Westchester Medical Center's 10 hospital network that conducts over 7 million tests on a yearly basis, exclusive partnerships with the NFL, NBA and MLS, as well as government contracts with the Centers for Disease Control and Prevention to test weekly all 950 schools in New York City and to test all 50,000 NY MTA employees on a weekly basis.
        • Last quarter BRL's profit margins were ~10% against Quest and LabCorp reporting ~27% profit margins. If BRL only made up half of that difference, BRL's annualized EBITDA would be >$400 million a year.
    • Somatrogon, OPKO's hGH crown jewel is worth north of $2 billion. Pfizer paid OPKO ~$600 million upfront for OPKO to complete clinical trials across the world (over 24 trials in 83 countries) from 2017-2019 and Pfizer announced just a few weeks ago that the trial has passed Phase 3. Pfizer also discussed Somatrogon's 2021 launch on a recent earnings call. OPKO is owed ~20% royalties on both of Pfizer's currently selling $500 million hGH drug, as well as on sales of Somatrogon and an additional $275 million in milestones. We estimate this will produce an annual profit stream of ~$200 million.
      • Somatrogon's only competitor, Ascendis, has no commercial partner, little to no revenue and has never successfully commercialized a drug. Further, due to Somatrogon's orphan drug status, it is afforded regulatory protections in the U.S. and Europe for 7-12 years, effectively making it among the most consistent drugs in the industry with scarcity value due to the dearth of 9-figure royalty drugs in the market.
        • $2 billion is extraordinarily conservative: Ascendis, trades at a market capitalization of $8.5 billion = ~3 times the entire value of OPKO.
      • We believe many royalty partners would pay OPKO >$1 billion TODAY, for the rights to just a portion of the Somatrogon royalty stream because we are in an environment starved for yield with interest rates at all-time lows and the scarcity value of the asset, its regulatory protections and top-grade commercial partner in Pfizer makes Somatrogon among the highest quality royalty assets in the market.

    Today on OPKO's earnings call, investors and sell-side analysts will have the ability to ask management important questions. We believe if investors ask these questions and read through our presentation, they will have little trouble in understanding the staggering disconnect between OPKO's current trading value and its current market value:

    Do you believe Somatrogon can produce a 9-figure royalty stream, and given OPKO is not getting anywhere near the true value for the asset today, would you consider selling some of the royalty, which would bring in near-term cash to be used to purchase undervalued shares back, a dividend or other accretive uses? If so, do you believe there is interest for these assets?

    1) BioReference's margins are less than half that of Quest and LabCorp. Is there an opportunity to close that margin gap at least partway, or is 10% the maximum BioReference can produce?



    2) Dr. Jon R. Cohen, CEO of BioReference, has described the COVID-19 "halo effect" which has helped grow the BRL base customer business, in turn increasing the base business growth rate. Is this still the case?



    3) Rayaldee is already a royalty stream, licensed to Vifor Pharma in Europe and JT in Japan, however OPKO has an 89-person sales force1 to sell Rayaldee in the U.S., which is subscale. We believe management should consider also licensing the current use of Rayaldee in the U.S., thereby incurring $75 million in cost savings while still receiving a rapidly growing royalty stream. Is management open to considering additional usage licenses of Rayaldee in the U.S.?



    4) Is management confident in the prospects of success for Rayaldee's trial as a treatment of COVID-19 for mild to moderate symptoms with two primary endpoints?

    1. Rayaldee has been fast tracked for approval for treatment of COVID-19 for mild to moderate symptoms with two primary endpoints. One endpoint was reached already in its Phase IV trial. OPKO has done a poor job of marketing this fact, allowing unproven, reckless drugs like anti-malaria tablets to be touted by the President and others as a treatment, but it's little known that OPKO is sitting on a >$1 billion opportunity that could save countless lives.2

    2. We trust should investors ask management's belief in the prospects of success for the trial, they will be encouraged by the answer, and magnitude of the opportunity.

    We believe if investors ask these questions on today's earnings call, it will become quickly clear why there is such a staggering disconnect between OPKO's market price and its intrinsic value.

    We expect management to cite the inflection and tailwinds in their business, but should any investors remain unsatisfied, we will be hosting a conference call to be announced after the earnings release.

    About Sian Capital

    Founded by veteran portfolio manager Anish Monga, Sian Capital, LLC is a New York-based asset management firm that employs a focused, event-driven investment approach. Sian's unique mix of cross-sector experience and activism expertise enables it to identify and invest in what are often overlooked or under-covered investment opportunities.

    Contacts

    Profile

    Greg Marose / Charlotte Kiaie

    /

    _______________

    1 As disclosed in OPKO's recent 10-K filing.

    2 https://medium.com/microbial-instincts/the-first-clinical-trial-to-support-vitamin-d-therapy-for-covid-19-906a9d907468

    View Full Article Hide Full Article
  22. MIAMI, Oct. 29, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended September 30, 2020.

    Third Quarter Business Highlights

    • BioReference Laboratories' COVID-19 PCR testing volume increased 61% over the second quarter of 2020. During the third quarter, BioReference Laboratories (BRL) processed approximately 3.5 million COVID-19 PCR tests and currently has the capacity to process more than 70,000 tests per day. In addition, the laboratory performed approximately 300,000 COVID-19 serology tests to measure SARS-CoV-2 specific antibody levels with the capacity to process more than 400,000 serology tests per day.

      BRL announced additional COVID-19 testing agreements…

    MIAMI, Oct. 29, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended September 30, 2020.

    Third Quarter Business Highlights

    • BioReference Laboratories' COVID-19 PCR testing volume increased 61% over the second quarter of 2020. During the third quarter, BioReference Laboratories (BRL) processed approximately 3.5 million COVID-19 PCR tests and currently has the capacity to process more than 70,000 tests per day. In addition, the laboratory performed approximately 300,000 COVID-19 serology tests to measure SARS-CoV-2 specific antibody levels with the capacity to process more than 400,000 serology tests per day.



      BRL announced additional COVID-19 testing agreements for New York City schools through a continued collaboration with New York City, the Department of Health and Hospital Corporation, the Test & Trace Corp. and the Department of Education. Through these agreements, BRL is testing students, teachers and staff in nearly 1,000 public schools across New York. BRL continues to provide COVID-19 testing services to numerous states, cities, professional sports associations and healthcare organizations, as well as to over 600 drive-thru and retail pharmacy testing sites nationwide.
    • Positive somatrogon Phase 3 topline results reported from crossover pediatric study. A global Phase 3 study of somatrogon administered once-weekly to children 3 to <18 years of age with growth hormone deficiency met its primary objective of improved treatment burden compared to daily injection of Genotropin® as measured by the mean overall Life Interference total score after 12 weeks of treatment.



    • Somatrogon global regulatory submissions: Pfizer remains on schedule with respect to its regulatory submissions for marketing approval of somatrogon for children with growth hormone deficiency in the U.S. in the fourth quarter of this year and in Europe and Japan in the first half of 2021.



    • RAYALDEE has received marketing authorizations in seven European countries. Vifor Fresenius Medical Care Renal Pharma, OPKO's commercial partner for RAYALDEE in Europe, has received marketing authorizations for RAYALDEE for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency in the United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the Netherlands. Market authorizations from Spain, Portugal, Italy and Switzerland are still pending. Market launch of RAYALDEE in authorized countries is expected to begin next year.



    • RAYALDEE total prescriptions reported by IQVIA increased 13% compared with the third quarter of 2019.   Total prescriptions for the three months ended September 30, 2020 increased to approximately 16,700, compared with approximately 14,800 for the third quarter of 2019. During the third quarter of 2020, demand for RAYALDEE was impacted by challenges in onboarding new patients because of the COVID-19 pandemic.



    • RAYALDEE Phase 2 clinical trial initiated in patients with mild-to-moderate COVID-19.   OPKO initiated a Phase 2 clinical trial with RAYALDEE as a treatment for mild to moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-releasCapsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 CKD who are at increased risk for developing more severe illness. The REsCue trial will randomize COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo, and 2 weeks of follow-up. Primary efficacy endpoints are raising and maintaining serum total 25-hydroxyvitamin D within the range of 50-100 ng/mL and time to resolution of COVID-19 symptoms. Numerous independent studies report a correlation between vitamin D status and COVID-19 risk and severity.



    • GeneDx enters into agreement with Pediatrix Medical Group to offer neonatal genomic services. In August 2020, BRL's GeneDx subsidiary announced an agreement with Pediatrix Medical Group, the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units staffed by neonatologists affiliated with Pediatrix. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and to facilitate the development of novel precision medicine solutions for pediatric care.



    • BioReference Laboratories launches best-in-class next-generation sequencing assay.   In September 2020, BRL, along with its GenPath specialty oncology division, announced the launch of OnkoSight Advanced™, a next-generation sequencing (NGS) assay that enables revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples. OnkoSight Advanced NGS testing provides targeted gene content that is aligned with the latest National Comprehensive Cancer Network and World Health Organization guideline recommendations to provide critical insight into many of the most common cancer types. Each OnkoSight Advanced panel includes key biomarkers – Tumor Mutation Burden and Tumor-Only Microsatellite, critical when profiling advanced-stage malignancies to guide potential immunotherapy.

    Third Quarter Financial Results

    • Net income for the third quarter of 2020 was $23.7 million, or $0.04 per diluted share, compared with a net loss of $62.0 million, or $0.11 per share, for the comparable period of 2019.   Consolidated revenues for the third quarter of 2020 were $428.1 million compared with $228.8 million for the comparable period of 2019. 
    • Diagnostics: Revenue from services in the third quarter of 2020 was $392.5 million compared with $181.1 million in the prior-year period, primarily due to increased COVID-19 testing volumes, partially offset by reduced clinical and genomic test volumes related to the pandemic and lower clinical and genomic test reimbursement. In addition, the Company received a $10.0 million grant from the CARES Act in the third quarter. Total costs and expenses were $346.4 million in the third quarter of 2020 compared with $197.5 million in the third quarter of 2019.   This increase represents higher volumes from both COVID-19 testing and from the core testing business.   Operating income was $46.2 million in the third quarter of 2020 compared with an operating loss of $16.4 million in the prior-year period, an improvement of $62.5 million.
    • Pharmaceuticals: Revenue from products in the third quarter of 2020 was $28.7 million compared with $26.2 million in the third quarter of 2019, with the increase primarily attributable to higher sales at OPKO Chile and an increase in net sales of RAYALDEE to $8.1 million in the third quarter of 2020 compared with $7.4 million in the prior-year period. Revenue from transfer of intellectual property was $6.8 million in the third quarter of 2020 compared with $20.7 million in the third quarter of 2019 reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. Total costs and expenses were $49.9 million in the third quarter of 2020 compared with $61.1 million in the prior-year period, with the decline primarily attributable to lower research and development expenses due to the completion of the pediatric human growth hormone Phase 3 trial. The operating loss was $14.4 million in the third quarter of 2020 compared with $14.2 million in the third quarter of 2019.
    • Cash and equivalents: Cash, cash equivalents and marketable securities were $36.3 million as of September 30, 2020, which reflects the repayment, in full, of its line of credit with JP Morgan utilizing cash generated from operations of $63.0 million during the three months ended September 30, 2020.   In addition, the Company has availability under its line of credit with JP Morgan of $64.7 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis.  

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss third quarter financial results in greater detail during a conference call and live audio webcast at 4:30 p.m. Eastern time today, October 29, 2020. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 4542807. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 3Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 3Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 4542807.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, the demand for testing, our capacity for testing and expected turnaround time, the impact of COVID-19 on all of our businesses, positively and negatively, our ability to expand our capacity should there be additional demand, the availability of resources, including labor, equipment and supplies, to meet demand for testing and the potential impact on us should these resources be constrained, whether our turnaround time be extended or our performance quality decline, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of unfavorable new clinical data and further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether we will be able to make the expected regulatory submissions for somatrogon during the expected time periods or at all, whether the applicable regulatory agencies will accept our submissions, whether the Rayaldee study for patients with mild-to moderate COVID-19 will initiate or begin enrolling subjects later this quarter or be completed at all, whether our other ongoing and future clinical trials will be successfully enrolled or completed on a timely basis or at all and whether the data from any of our trials will support submission or approval, validation and/or reimbursement for our products, whether RAYALDEE prescriptions will continue to increase, our ability to market and sell any of our products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in millions)

     As of
     September 30,

    2020
     December 31,

    2019
    Assets:       
    Cash, cash equivalents and marketable securities$36.3  $85.5 
    Other current assets 391.8   238.5 
    Total Current Assets 428.1   324.0 
    In-process Research and Development and Goodwill 1,266.0   1,262.1 
    Other assets 677.2   723.2 
         Total Assets$2,371.3  $2,309.3 
            
    Liabilities and Equity:       
    Current liabilities$335.9  $249.1 
    Convertible Notes 219.2   211.2 
    Deferred tax liabilities, net 119.2   118.7 
    Other long-term liabilities, principally contract liabilities,

    contingent consideration and lines of credit
     

    73.2
       115.5 
    Total Liabilities 747.5   694.5 
    Equity 1,623.8   1,614.8 
         Total Liabilities and Equity$2,371.3  $2,309.3 





    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in millions, except share and per share data)

     For the three months ended

    September 30,
     For the nine months ended

    September 30,
      2020   2019   2020   2019 
    Revenues               
    Revenue from services$382.5  $181.1  $804.3  $538.5 
    Revenue from products 28.7   26.2   89.1   80.1 
    Revenue from transfer of intellectual property 16.9   21.5   47.3   59.0 
         Total revenues 428.1   228.8   940.7   677.6 
    Costs and expenses               
    Cost of revenues 272.8   141.9   575.7   430.2 
    Selling, general and administrative 99.9   80.6   253.7   264.2 
    Research and development 18.5   30.0   57.9   94.8 
    Contingent consideration 1.1   (1.1  1.3   (0.1
    Amortization of intangible assets 13.9   16.4   43.8   49.4 
    Asset impairment charges 0.0   0.0   0.0   0.7 
         Total Costs and expenses 406.2   267.8   932.4   839.2 
    Operating income (loss) 21.9   (39.0)  8.3   (161.6)
    Other income and (expense), net (1.3)  (20.9)  (5.6)  (35.0)
    Loss before income taxes and investment losses 20.6   (59.9)  2.7   (196.6)
    Income tax benefit (provision) 3.2   (1.8)  (4.0)  (3.6)
    Loss before investment losses 23.8   (61.7)  (1.3)  (200.2)
    Loss from investments in investees (0.1)  (0.3)  (0.4)  (2.4)
    Net income (loss)$23.7  $(62.0) $(1.7) $(202.6)
    Income (loss) per share,

        basic and diluted
    $0.04  $(0.11) $(0.00) $(0.35)
    Weighted average common shares

      outstanding, basic and diluted
     640,699,982   586,351,045   640,619,485   586,348,791 

    Primary Logo

    View Full Article Hide Full Article
  23. ELMWOOD PARK, N.J., Oct. 20, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), is now accepting specimens for a new multiplex COVID-19 and influenza test for use by healthcare providers, clinics and health systems throughout the United States, to aid in the diagnosis of COVID-19 and Influenza A or B (flu).

    Differentiating COVID-19 and Influenza A or B infection(s) is especially important, as symptoms of COVID-19 and seasonal respiratory infections can be similar. BioReference offers a multiplex test for COVID-19 and Influenza A and B, using a single sample. This allows for more rapid diagnosis, conserves critical testing supplies, and provides surveillance for flu and COVID-19. Identifying the correct infectious agent, especially in high-risk populations, will allow for early treatment and appropriate management.

    The multiplex test may be performed on healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens collected in a healthcare setting supervised by a healthcare provider. 

    "As cases of COVID-19 rise, arming healthcare professionals with reliable laboratory solutions to help achieve an accurate diagnosis is imperative in limiting the spread of the virus," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Patient care is at the center of our test offering and this multiplex test allows for healthcare providers to differentiate between COVID-19 and influenza by swabbing a patient one time."

    Specimens from patients to identify COVID-19 disease will not be obtained at BioReference Patient Service Centers; they will be collected at physician offices, hospitals or other clinic settings.

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's multiplex COVID-19 and influenza test, the ability of the test to rapidly and accurately identify the correct infectious agent, and the role and value of the information provided and its impact on early treatment and appropriate management.  Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-multiplex-covid-19-and-influenza-ab-test-301155355.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  24. MIAMI, Oct. 13, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended September 30, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, October 29, 2020. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on October 29th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 4542807. Upon registering, participants will receive dial-in numbers…

    MIAMI, Oct. 13, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended September 30, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, October 29, 2020. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on October 29th beginning at 4:30 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 4542807. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 3Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 3Q20 Results Conference Call. A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 4542807.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  25. ELMWOOD PARK, N.J., Oct. 9, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the beginning of its COVID-19 testing program for New York City schools throughout the 2020-2021 school year to help ensure a safer school environment.

    Continuing a strategic collaboration with New York City, the Department of Health, New York City Health and Hospital Corporation (NYC Health + Hospitals), the Test & Trace Corp, and the Department of Education, BioReference is performing COVID-19 molecular testing for NYC schools. In addition, BioReference is collecting specimens from principals, teachers, administration and students from over 950 schools across NYC.

    "This school year for New York City and other school systems around the world is vastly different due to the global pandemic, and BioReference is privileged to aid in keeping NYC schools safe," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories.

    About BioReference Laboratories, Inc. 

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health, Inc. 

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements 

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the role COVID-19 testing will play in supporting a safer classroom environment, the accuracy and availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of educators, students and their families, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-covid-19-testing-program-for-new-york-city-schools-301149155.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  26. Results demonstrated improved treatment burden with once-weekly injection –

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005030/en/

    Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12…

    Results demonstrated improved treatment burden with once-weekly injection –

    Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that C0311002, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency (GHD), met its primary endpoint of improved treatment burden compared to GENOTROPIN® (somatropin) for injection administered once-daily.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005030/en/

    Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). The point estimate of the treatment difference was -15.49 (-19.71, -11.27 (95% CI); p<0.0001) in favor of somatrogon at the nominal 0.05 level. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen.

    "We're encouraged by findings to date that demonstrate once-weekly somatrogon, if approved, has the potential to reduce lifestyle interference, support patient preference, and improve adherence as compared to a daily treatment," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "Patients and their loved ones have endured the burden of daily growth hormone injections for nearly 40 years, and we are working to improve this current standard of care with a long-acting, weekly option for the growth hormone disorders community."

    No serious adverse events (SAEs) were reported during either of the treatment periods, and one participant discontinued use of somatrogon following a nonserious treatment-emergent adverse event (AE). The incidence of treatment-emergent AEs between the treatment arms were comparable and all AEs were mild to moderate in severity.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product. The companies will evaluate the potential for additional pediatric and adult indications, as appropriate.

    About the Study

    C0311002 is a Phase 3, randomized, multicenter, open-label, crossover study assessing subject perception of treatment burden with use of somatrogon administered once-weekly versus GENOTROPIN® administered once-daily in children 3 to <18 years of age with growth hormone deficiency (GHD). The primary objective of the crossover study, which included 87 randomized and treated subjects (43 randomized to Sequence 1 [somatropin followed by somatrogon] and 44 randomized to Sequence 2 [somatrogon followed by somatropin], was to evaluate the treatment burden of a somatrogon once-weekly injection schedule and a somatropin once-daily injection schedule, as assessed by the difference in mean overall Life Interference total scores after each 12-week treatment schedule experience.

    About Somatrogon

    Somatrogon is a new molecular entity that contains the natural sequence of growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus. The CTPs extend the half-life of the molecule. Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

    About GENOTROPIN® (somatropin)

    GENOTROPIN (somatropin) is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

    Important GENOTROPIN® Safety Information

    • Growth hormone should not be used to increase height in children after the growth plates have closed.
    • Growth hormone should not be used in patients with diabetes who have certain types of diabetic retinopathy (eye problems).
    • Growth hormone should not be used in patients with cancer or who are being treated for cancer. Growth hormone deficiency can be caused by brain tumors. So, the presence of these brain tumors should be ruled out before treatment is started. Growth hormone should not be used if it is shown that a previous brain tumor has come back or is getting larger.
    • Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure.
    • Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.
    • GENOTROPIN should not be used by patients who have had an allergy or bad reaction to somatropin or any of the other ingredients in GENOTROPIN.
    • Some patients have developed diabetes mellitus while taking GENOTROPIN. Dosage of diabetes medicines may need to be adjusted during growth hormone treatment. Patients should be watched carefully if growth hormone is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.
    • In childhood cancer survivors, treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors. This risk may be higher in patients who were treated with cranial radiation. Also, patients and their doctors should check regularly for any skin changes.
    • A small number of patients treated with growth hormone have had increased pressure in the brain. This can cause headaches and problems with vision. Treatment should be stopped and reassessed in these patients. Patients with Turner syndrome and Prader-Willi syndrome may be at higher risk of developing increased pressure in the brain.
    • Thyroid function should be checked regularly during growth hormone therapy. Thyroid hormone replacement therapy should be started or adjusted if needed.
    • Patients treated with growth hormone should be checked regularly if they are receiving standard hormone replacement therapy to treat a lack of more than one hormone.
    • In children experiencing rapid growth, curvature of the spine may develop or worsen. This is also called scoliosis. Patients with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy.
    • In children experiencing rapid growth, limping or hip or knee pain may occur. If a child getting growth hormone therapy starts to limp or gets hip or knee pain, the child's doctor should be notified and the child should be examined.
    • Growth hormone should only be used during pregnancy if clearly needed. It should be used with caution in nursing mothers because it is not known whether growth hormone is passed into human milk.
    • Use a different place on the body each day for growth hormone injections. This can help to prevent skin problems such as lumpiness or soreness.
    • Some cases of pancreatitis (inflamed pancreas) have been reported rarely in children and adults receiving growth hormone. There is some evidence that there is a greater risk of this in children than in adults. Literature suggests that girls who have Turner syndrome may have a greater risk of pancreatitis than other children taking growth hormone. In any child who develops lasting, severe abdominal pain, pancreatitis should be considered.
    • In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash. Other side effects were fat loss, headache, blood in the urine, low thyroid activity, and mildly increased blood sugar.
    • In studies of GENOTROPIN in children born SGA, side effects included temporarily elevated blood sugar, increased pressure in the brain, early puberty, abnormal jaw growth, injection site reactions, growth of moles, and worsening of scoliosis (curvature of the spine).
    • Deaths have been reported with the use of growth hormone in children with Prader-Willi syndrome. These children were extremely overweight, had breathing problems, and/or lung infection. All patients with Prader-Willi syndrome should be examined for these problems. They should also establish healthy weight control.
    • In studies of GENOTROPIN in children with PWS, side effects included fluid retention, aggressiveness, joint and muscle pain, hair loss, headache, and increased pressure in the brain.
    • Turner syndrome patients taking growth hormone therapy may be more likely to get ear infections. This is also called otitis media.
    • In studies of GENOTROPIN in children with Turner syndrome, side effects included flu, throat, ear, or sinus infection, runny nose, joint pain, and urinary tract infection.
    • In studies of GENOTROPIN in children with ISS, side effects included respiratory illnesses, flu, throat infection, inflammation of the nose and throat, stomach pain, headaches, increased appetite, fever, fracture, mood changes, and joint pain.
    • Women who are taking estrogen by mouth may take GENOTROPIN. They may need a larger dose of growth hormone.
    • GENOTROPIN may be taken by the elderly. Elderly patients may be more likely to have side effects with growth hormone therapy.
    • In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation. Usually these side effects did not last long and depended on the dose of GENOTROPIN being taken.
    • GENOTROPIN cartridges contain m-Cresol and should not be used by patients allergic to it.
    • A health care provider will help you with the first injection. He or she will also train you on how to inject GENOTROPIN.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For the full Prescribing Information for GENOTROPIN, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=577.

    GENOTROPIN Indications and Usage in the U.S.

    GENOTROPIN is a prescription product for the treatment of growth failure in children:

    • Who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).
    • With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor.
    • Who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2 years. This condition is called small for gestational age (SGA).
    • With a genetic condition called Turner syndrome (TS).
    • With idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height, and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause.

    GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.

    About Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    Pfizer Inc.: Breakthroughs that change patients' lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    DISCLOSURE NOTICE:

    The information contained in this release is as of October 6, 2020. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications for any potential indications for somatrogon may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's or OPKO's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2019 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results" and "Cautionary Statement Regarding Forward-Looking Statements", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and, as applicable, www.pfizer.com and www.OPKO.com.

    View Full Article Hide Full Article
  27. MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announces the initiation of a Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.

    The trial will be conducted at multiple COVID-19 outpatient clinics in the U.S.  The initial sites are located primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest…

    MIAMI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announces the initiation of a Phase 2 trial with RAYALDEE® as a treatment for mild-to-moderate COVID-19.  The trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is expected to enroll approximately 160 subjects, many with stage 3 or 4 chronic kidney disease (CKD) who are at higher risk for developing more severe illness.

    The trial will be conducted at multiple COVID-19 outpatient clinics in the U.S.  The initial sites are located primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest. The first subjects are expected to be enrolled within the next few weeks.

    The REsCue trial will randomize COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up. Dosing with RAYALDEE will commence with 300 mcg per day on Days 1, 2 and 3 followed by 60 mcg per day on Days 4 through 27. Primary efficacy endpoints are raising and maintaining serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL and time to resolution of COVID-19 symptoms.  Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation below 94%, need for and duration of hospitalizations, requirement for mechanical ventilation, mortality rate, and severity and duration of illness evidenced by quality-of-life measures.  More information about this trial will soon become available on https://clinicaltrials.gov/.

    Numerous independent studies have reported a correlation between vitamin D status and COVID-19 risk and severity.  OPKO expects to report topline results from this Phase 2 trial before year-end.

    About RAYALDEE

    RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.  The product is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH).  RAYALDEE, approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in November 2016. 

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements



    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "could," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including product development efforts and the expected benefits of RAYALDEE, whether and when we will initiate and complete the clinical studies contemplated for RAYALDEE and whether final study data will be positive, our ability to develop and commercialize RAYALDEE for COVID-19 patients, whether RAYALDEE is capable of treating  patients with COVID-19 including whether RAYALDEE could impact the SARS-CoV-2 virus or cytokine storm,  or have any impact on the severity of the disease or that it will effectively raise and maintain serum total 25D consistently at or above 50ng/mL, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects.   Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners for RAYALDEE, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    CONTACTS:

    Investors

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  28. MIAMI, Sept. 02, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in two upcoming virtual investor conferences.

    • 13th Annual Barrington Research Fall Conference, September 9, 2020. Management will be available for one-on-one and small group video conference calls with investors during the event.
       
    • H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 14 - 16, 2020. Management will deliver a company presentation on Tuesday, September 15th at 10:00 a.m. ET and will be available for one-on-one meetings. A live webcast of the presentation will be available on the investor section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical…

    MIAMI, Sept. 02, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will be participating in two upcoming virtual investor conferences.

    • 13th Annual Barrington Research Fall Conference, September 9, 2020. Management will be available for one-on-one and small group video conference calls with investors during the event.

       
    • H.C. Wainwright 22nd Annual Global Investment Virtual Conference, September 14 - 16, 2020. Management will deliver a company presentation on Tuesday, September 15th at 10:00 a.m. ET and will be available for one-on-one meetings. A live webcast of the presentation will be available on the investor section of OPKO's website here.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

     

    Primary Logo

    View Full Article Hide Full Article
  29. ELMWOOD PARK, N.J., Sept. 2, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today began testing New York City principals, teachers and other staff for COVID-19, across the five boroughs, in preparation for a safer back-to-school environment.

    Through a strategic collaboration with BioReference, New York City, the Department of Health and New York City Health and Hospital Corporation (NYC Health + Hospitals) will collect specimens from principals, teachers and staff members across eight locations. BioReference will then perform COVID-19 PCR tests for the principals, teachers and other school staff at its Elmwood Park, New Jersey laboratory facility. The hours of operation for collection of specimens will be 8:00 a.m. to 8:00 p.m. ET, Monday through Sunday, beginning today and concluding Monday, September 7. Registration and appointment selection is required. To register for collection of a specimen for a COVID-19 test, visit: https://appointments.bioreference.com/nycschools.

    "As NYC schools prepare for the upcoming year, COVID-19 testing will play a pivotal role in supporting a safer overall classroom environment for educators, students and their families," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The systematic measures put in place by New York City reaffirm the dedication to safety and education in New York City."

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the role COVID-19 testing will play in supporting a safer classroom environment, the accuracy and availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of educators, students and their families, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-announces-new-york-city-schools-covid-19-testing-program-301122624.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  30. ELMWOOD PARK, N.J., Sept. 1, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), along with its specialty oncology division, GenPath, today announced the launch of OnkoSight AdvancedTM, a next-generation sequencing (NGS) assay that enables revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples.

    OnkoSight Advanced NGS testing provides targeted gene content that is aligned with the latest National Comprehensive Cancer Network (NCCN) and World Health Organization (WHO) guideline recommendations, to provide critical insights into many of the most common cancer types. Additionally, OnkoSight Advanced panels each include key biomarkers: Tumor Mutation Burden (TMB) and Tumor-Only Microsatellite (MSI), which are critical when profiling advanced stage tumor malignancies to guide potential immunotherapy.

    "OnkoSight Advanced NGS panels are tumor-type specific and optimized to exclude extraneous gene content, significantly improving clinical actionability and relevance of the data to effectively guide real-world oncology patient management," said Bevan Tandon, M.D., Hematopathologist and Molecular Pathologist, Director of Cancer Genomics at BioReference Laboratories. "Coupled with BioReference and GenPath's comprehensive oncology test menu, OnkoSight Advanced empowers physicians to make informed decisions effectively and efficiently."

    "A cancer diagnosis and treatment path are difficult to address with patients and their families, which drives the importance of understanding a patient's risk group and accurately diagnosing the type of cancer, to result in a targeted treatment strategy and prognosis assessment," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The latest advancement from BioReference's oncology division underscores the commitment to patient-centric care through our industry-leading result turnaround time with enhanced accuracy."

    For more information about OnkoSight Advanced, visit: https://www.genpathdiagnostics.com/hcp/onkosight-advanced-tm-next-generation-sequencing/.

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding our NGS assay, whether it will prove to be best-in-class or revolutionary, whether the test will perform or be as accurate as anticipated,  the role and value of the information provided and its impact on decisions to be made by physicians, and statements about our result turnaround time and accuracy, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-best-in-class-next-generation-sequencing-ngs-assay-301122384.html

    SOURCE BioReference Laboratories, Inc.

    View Full Article Hide Full Article
  31. GAITHERSBURG, Md., Aug. 12, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), the global leader in neonatal and pediatric genetic testing, announced the entrance into an agreement with Pediatrix Medical Group ("Pediatrix"), the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units ("NICUs") staffed by Pediatrix's affiliated neonatologists. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and facilitate the development of novel precision medicine…

    GAITHERSBURG, Md., Aug. 12, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), the global leader in neonatal and pediatric genetic testing, announced the entrance into an agreement with Pediatrix Medical Group ("Pediatrix"), the nation's leading provider of maternal-fetal, and pediatric medical and surgical subspecialty physician services, to offer state-of-the-art, next-generation genomic sequencing to support clinical diagnosis in neonatal intensive care units ("NICUs") staffed by Pediatrix's affiliated neonatologists. The sequencing is designed to enhance diagnostic capabilities in order to lessen the impact of disease and facilitate the development of novel precision medicine solutions for pediatric care. The initial offering will include whole exome and whole genome sequencing and genomic support services under the brand Detect Genomix and the initial clinical diagnostic support services will be made available to hospitals and patients across the country.

    "Our innovative technology, advanced analytics, customized genomic reports and genetic counseling offerings coupled with Pediatrix's vast neonatal clinical experience and expansive coverage across the country set the stage for this arrangement to provide the first comprehensive offering of this type to hospitals and health systems nationwide," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories and GeneDx. 

    "Our combined network of more than 2,200 affiliated physicians and GeneDx's more than 100 genetic counselors will make Detect Genomix one of the nation's largest neonatal genomics platforms," said Ingrid Vasiliu-Feltes, M.D., MBA, Chief Quality and Innovation Officer at Pediatrix. "Genetic disorders and congenital anomalies are a leading cause of neonatal morbidity and mortality, and time to diagnosis is a crucial factor in the treatment of the patient. This arrangement is designed to provide Pediatrix-affiliated neonatologists with access to the latest sequencing technology."

    About GeneDx, Inc.

    GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.  

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the strengths and resources of GeneDx and its counterparty, the role and value of genomic sequencing and whether such sequencing will significantly enhance diagnostic capabilities or lessen the impact of disease or facilitate the development of novel precision medicine solutions for pediatric care; rapid whole exome and genome sequencing in neonatal intensive care units; statements about the experience and technology of each of GeneDx and its counterparty; statements about the uniqueness of the proposed offerings of Detect Genomix; as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product and service development, federal and state regulations and legislation, and the regulatory process for testing and services, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-genedx-enters-into-agreement-with-pediatrix-medical-group-to-offer-neonatal-genomic-services-301110912.html

    SOURCE GeneDx, Inc.

    View Full Article Hide Full Article
  32. GAITHERSBURG, Md., Aug. 6, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the launch of GenomeXpress, a rapid genome sequencing test. Verbal GenomeXpress results of pathogenic and/or likely pathogenic variants in known disease causing genes are delivered to the ordering healthcare provider within approximately seven days after the start of testing. A written report for all confirmed variants is sent to the provider within approximately 14 days after start of testing. With the addition of GenomeXpress, GeneDx expands its industry-leading clinical genomics portfolio to now include three rapid sequencing options.

    GAITHERSBURG, Md., Aug. 6, 2020 /PRNewswire/ -- GeneDx, Inc., a subsidiary of BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the launch of GenomeXpress, a rapid genome sequencing test. Verbal GenomeXpress results of pathogenic and/or likely pathogenic variants in known disease causing genes are delivered to the ordering healthcare provider within approximately seven days after the start of testing. A written report for all confirmed variants is sent to the provider within approximately 14 days after start of testing. With the addition of GenomeXpress, GeneDx expands its industry-leading clinical genomics portfolio to now include three rapid sequencing options.

    Genome sequencing is a test used to identify variations in any part of the genome and is an important tool for diagnosing genetic diseases. By including both protein-coding and non-coding regions of the human genome including promoter, intronic, and untranslated regions, GenomeXpress allows for the detection of characterized/pathogenic variants in regions that are not assessed by exome sequencing. Genetic changes can cause over 13,000 different diseases and patients often present with overlapping symptoms.1 Finding the correct diagnosis is not always straight-forward and may require multiple tests, costly evaluations, invasive procedures and long hospital stays. A rapid diagnosis can alter management, shorten the length of hospital stays, reduce healthcare costs and save lives. 

    "With the new offering of GenomeXpress, we are advancing healthcare," said Jane Juusola, Ph.D., FACMG, Director of Clinical Genomics for GeneDx. "Rapid genome sequencing paired with GeneDx's massive and ever-expanding genomic database provides clinicians, patients and their families with more meaningful information. As our database grows, we are better able to distinguish likely pathogenic variants from likely benign variants and subsequently identify new disease-causing genes. Every patient who receives a GenomeXpress test will benefit from both our current and future knowledge of genetic disease."

    "New and emerging scientific understanding is an imperative aspect of genomics," said Adam Logal, President of GeneDx and Chief Financial Officer of OPKO Health. "Leveraging GeneDx's diverse database with a rapid genome sequencing test may provide patients and their families with options they did not have before. GenomeXpress utilizes GeneDx's clinical genomics expertise, laboratory excellence and the limitless value of the genome, as a future-facing sequencing technology."

    Genome sequencing has a diagnostic utility of 42-73%1-6 with a higher yield for cases that specifically include other family members.2,5,7-11 With a clinical utility of greater than four times that of chromosomal microarray, genome sequencing should be considered a first-line genomics test for children with suspected genetic diseases.2

    About GeneDx, Inc.

    GeneDx, Inc. is a global leader in genomics, providing testing to patients and their families from more than 55 countries. Led by its world-renowned clinical genomics program, GeneDx has an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx offers a suite of additional genetic testing services, including diagnostic testing for hereditary cancers, cardiac, mitochondrial, neurological disorders, prenatal diagnostics and targeted variant testing. GeneDx is a subsidiary of BioReference Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity, our ability to increase COVID 19 testing availability nationwide, as well as the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    References:

    1. Clark et al., 2019
    2. Clark et al., 2018
    3. Soden et al. 2014
    4. Rady Children's Hospital-San Diego (2020). Project Baby Bear Final Report
    5. Petrikin et al., 2018
    6. Gilissen et al. 2014
    7. Bick et al., 2017
    8. Willig et al., 2015
    9. Farnaes et al., 2018
    10. Kingsmore et al., 2019
    11. Scocchia et al., 2019

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-genedx-adds-genomexpress-to-its-industry-leading-clinical-genomics-portfolio-301107276.html

    SOURCE GeneDx, Inc.

    View Full Article Hide Full Article
  33. MIAMI, Aug. 05, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 9:00 a.m. Eastern time.  In addition, management will be hosting one-on-one meetings with investors via organized conference calls.

    A live webcast of the fireside chat can be accessed from the investor section of OPKO's website here. A replay of the event will be available for a period of time.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise…

    MIAMI, Aug. 05, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that management will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 9:00 a.m. Eastern time.  In addition, management will be hosting one-on-one meetings with investors via organized conference calls.

    A live webcast of the fireside chat can be accessed from the investor section of OPKO's website here. A replay of the event will be available for a period of time.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  34. MIAMI , July 30, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended June 30, 2020.

    Second Quarter Business Highlights

    • BioReference Laboratories increased COVID-19 testing nationwide:  During the second quarter, BioReference Laboratories (BRL) announced numerous partnerships and testing agreements with states, cities, professional sports associations and healthcare organizations, including the New York State Department of Health, New York City Health and Hospital Corporation and MagnaCare.  Further, BRL provided testing services for more than 500 drive-thru and retail testing sites around the country.  In July 2020, the Company announced that the…

    MIAMI , July 30, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended June 30, 2020.

    Second Quarter Business Highlights

    • BioReference Laboratories increased COVID-19 testing nationwide:  During the second quarter, BioReference Laboratories (BRL) announced numerous partnerships and testing agreements with states, cities, professional sports associations and healthcare organizations, including the New York State Department of Health, New York City Health and Hospital Corporation and MagnaCare.  Further, BRL provided testing services for more than 500 drive-thru and retail testing sites around the country.  In July 2020, the Company announced that the Centers for Disease Control and Prevention (CDC) awarded BRL an Indefinite Delivery Indefinite Quantity contract to provide Commercial Surge Capacity Testing for COVID-19, under which BRL will perform antibody testing to determine COVID-19 seroprevalence and other testing with key demographic data for the next four months.



      BRL processed approximately 2.2 million COVID-19 molecular tests during the second quarter and currently has a capacity of more than 50,000 daily. Since late April, when BRL began offering COVID-19 serology testing to measure SARS-CoV-2 specific antibody levels, it has performed approximately 331,600 tests with a significantly greater capacity.



    • Successful 4Kscore® Medicare appeal for tests performed during 2019:  As previously announced, Novitas Solutions issued its final Local Coverage Determination for Medicare payments for the 4Kscore test with defined coverage criteria, effective December 30, 2019. The Company received a favorable Medicare appeal decision from Novitas for previously denied Medicare claims for 4Kscore tests performed in 2019.  The COVID-19 pandemic impacted utilization of 4Kscore during the second quarter as many urology practices were either closed or operating at reduced capacity.  More than 8,400 tests were performed during the quarter despite fewer patient visits and access to physicians. The volume of 4Kscore tests has been increasing in recent weeks with the gradual re-opening of the economy and patients resuming visits to their physicians.



    • Positive somatrogon topline results reported from Japan pediatric Phase 3 efficacy and safety study:  In June, OPKO announced that its Japan Phase 3 clinical trial met its primary and secondary objectives, and demonstrated that the efficacy and safety of somatrogon administered once-weekly were comparable to GENOTROPIN® (somatropin) administered once-daily as measured by annual height velocity after 12 months of treatment in treatment-naïve Japanese pre-pubertal children with growth hormone deficiency. The findings were consistent with the results previously reported from the Company's global Phase 3 study.

       
    • Somatrogon abstracts presented at Endocrine Society's ENDO Online 2020:  Two abstracts regarding the somatrogon global Phase 3 trial were presented at ENDO Online 2020 by Cheri Deal, PhD, MD, FRCPC, Chief of Pediatric Endocrinology and Diabetes at CHU Sainte-Justine and Tenured Professor of Pediatrics at Université de Montréal, the Principal Investigator of the study.  The two abstracts, "Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency:  Results of the Pivotal Phase 3", and "Interpretation of Insulin-like Growth Factor (IGF-1) Levels Following Administration of Somatrogon (a long-acting Growth Hormone-hGH-CTP)," were published online in the April-May supplemental issue of the Journal of Endocrine Society. Dr. Deal's presentation included data demonstrating that somatrogon administered once weekly, met its endpoint of non-inferiority to daily GENOTROPIN® (somatropin) in height velocity and height standard deviation score (SDS).  In addition, Dr. Deal presented new data demonstrating that over 95% of patients had mean IGF-1 SDS levels within the normal range. IGF-1 SDS is a biomarker to evaluate efficacy and safety of human growth hormone replacement therapy.

       
    • Somatrogon global regulatory submissions:  The somatrogon Biologics License Application (BLA) submission in the U.S. is anticipated to occur in the fall of 2020.  In Europe, the Company's open-label study demonstrating benefit and compliance with reduced treatment burden will be completed this quarter, enabling Pfizer to submit for regulatory approval in Europe early next year. The somatrogon regulatory submission in Japan is expected during the first half of 2021.

       
    • RAYALDEE total prescriptions reported by IQVIA increased 45% in the second quarter of 2020 compared with the second quarter of 2019:  Total prescriptions for the three months ended June 30, 2020 increased to approximately 18,400, compared to approximately 12,700 for the second quarter of 2019.  During the second quarter of 2020, demand for RAYALDEE remained strong but prescription growth was impacted by limited access to physician offices by both patients and OPKO's sales representatives. 

       
    • RAYALDEE authorized for Phase 2 clinical trial in patients with mild-to-moderate COVID-19:  On June 1, 2020, OPKO announced that the U.S. Food and Drug Administration (FDA) authorized the Company to undertake a Phase 2 trial with RAYALDEE as a treatment for patients with mild-to moderate COVID-19.  The trial, entitled "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," will enroll approximately 160 subjects, including many with stage 3 or 4 chronic kidney disease. The REsCue trial will have four weeks of treatment with RAYALDEE or placebo and two weeks of follow-up.  There are two primary efficacy endpoints:  time to resolution of COVID-19 symptoms; and consistent attainment of serum total 25-hydroxyvitamin D levels greater than or equal to 50 ng/mL during the last week of treatment. The trial is expected to begin enrolling subjects later this quarter.

    Second Quarter Financial Results

    • Consolidated revenues for the second quarter of 2020 were $301.2 million compared with $226.4 million for the comparable period of 2019.   Net income for the second quarter of 2020 was $33.7 million, or $0.05 per diluted share, compared with a net loss of $59.8 million, or $0.10 per share, for the comparable period of 2019.   

       
    • Diagnostics:  Revenue from services in the second quarter of 2020 was $251.0 million compared with $178.5 million in the prior-year period, primarily due to increased COVID-19 testing volumes, partially offset by reduced clinical and genomic test volumes due to physician office closures and stay-at-home orders relating to the pandemic. In addition, the Company received a $6.2 million grant from the CARES Act in the second quarter. Total costs and expenses were $216.2 million in the second quarter of 2020 compared with $206.5 million in the second quarter of 2019.  Operating income was $40.9 million in the second quarter of 2020 compared with an operating loss of $28.0 million in the prior-year period, an improvement of $68.9 million.

       
    • Pharmaceuticals: Revenue from products in the second quarter of 2020 was $29.3 million compared with $28.7 million in in the second quarter of 2019, with the increase primarily attributable to higher sales of RAYALDEE of $8.6 million in the second quarter of 2020 compared with $5.7 million in the prior-year period. Revenue from licensing and intellectual property was $14.7 million in the second quarter of 2020 compared with $19.2 million in the second quarter of 2019, with the reduction primarily due to a decrease in the amortization of payments received from Pfizer, OPKO's commercial partner for its long-acting human growth hormone product, somatrogon. Total costs and expenses were $50.0 million in the second quarter of 2020 compared with $56.5 million in the prior-year period, with the decline primarily attributable to lower research and development expenses due to the completion of the pediatric Phase 3 trial. The operating loss was $6.0 million in the second quarter of 2020 compared with $8.6 million in the second quarter of 2019.



    • Cash and equivalents: Cash, cash equivalents and marketable securities were $21.6 million as of June 30, 2020.  In addition, the Company has availability under its line of credit with JP Morgan of $15.3 million and an unutilized $100 million credit facility that provides access to incremental capital on a non-dilutive basis. 

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast at 4:45 p.m. Eastern time today, July 30, 2020. Participants are requested to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 6946539. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 2Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 2Q20 Results Conference Call.  A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6946539.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, the demand for testing, our capacity for testing and expected turnaround time, the impact of COVID-19 on all of our businesses, positively and negatively, our ability to expand our capacity should there be additional demand, the availability of resources, including labor, equipment and supplies, to meet demand for testing and the potential impact on us should these resources be constrained, whether our turnaround time be extended or our performance quality decline, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of unfavorable new clinical data and further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether we will be able to make the expected regulatory submissions for somatrogon during the expected time periods or at all, whether the applicable regulatory agencies will accept our submissions,  whether the Rayaldee study for patients with mild-to moderate COVID-19 will initiate or begin enrolling subjects later this quarter or be completed at all, whether our other ongoing and future clinical trials will be successfully enrolled or completed on a timely basis or at all and whether the data from any of our trials will support submission or approval, validation and/or reimbursement for our products, whether RAYALDEE prescriptions will continue to increase, our ability to market and sell any of our products in development, whether the volume of 4Kscore tests will increase as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, the 4Kscore, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    —Tables to Follow—



    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Balance Sheets

    (in millions)

    (unaudited)

     As of
     June 30,

    2020
     December 31,

    2019
    Assets:       
    Cash and cash equivalents$21.6  $85.5 
    Other current assets 338.4   238.5 
    Total Current Assets 360.0   324.0 
    In-process Research and Development and Goodwill 1,261.8   1,262.1 
    Other assets 701.9   723.2 
    Total Assets$2,323.7  $2,309.3 
            
    Liabilities and Equity:       
    Current liabilities$279.5  $249.1 
    Convertible Notes 216.5   211.2 
    Deferred tax liabilities, net 119.0   118.7 
    Other long-term liabilities, principally contract liabilities, contingent consideration and lines of credit 120.4   115.5 
    Total Liabilities 735.4   694.5 
    Total Equity 1,588.3   1,614.8 
    Total Liabilities and Equity$2,323.7  $2,309.3 





    OPKO Health, Inc. and Subsidiaries

    Condensed Consolidated Statements of Operations

    (in millions, except share and per share data)

    (unaudited)

     For the three months ended

    June 30,
     For the six months ended

    June 30,
      2020   2019   2020   2019 
    Revenues               
    Revenue from services$251.0  $178.5  $421.8  $357.3 
    Revenue from products 29.3   28.7   60.4   54.0 
    Revenue from transfer of intellectual property  20.9    19.2    30.5    37.5 
    Total revenues 301.2   226.4   512.7   448.8 
    Costs and expenses               
    Cost of revenues 162.7   144.2   302.9   288.3 
    Selling, general and administrative 77.7   88.5   153.8   183.6 
    Research and development 17.6   28.3   39.4   64.8 
    Contingent consideration 1.1   (3.8)  0.3   1.0 
    Amortization of intangible assets 14.9   16.4   29.9   33.0 
    Asset impairment charges 0.0   0.0   0.0   0.7 
    Total Costs and expenses 274.0   273.6   526.3   571.4 
    Operating income (loss) 27.2   (47.2)  (13.6)  (122.6)
    Other income and (expense), net 12.7     (11.2)  (4.3)  (14.0)
    Income (loss) before income taxes and investment losses  39.9    (58.4)   (17.9)   (136.6)
    Income tax provision (6.0)  (1.1)  (7.2)  (1.9)
    Net income (loss) before investment losses  33.9    (59.5)   (25.1)   (138.5)
    Loss from investments in investees (0.2)  (0.3)  (0.3)  (2.1)
    Net income (loss)$33.7  $(59.8) $(25.4) $(140.6)
    Income (loss) per share, basic and diluted$0.05  $(0.10) $(0.04) $(0.24)
    Weighted average common shares outstanding, basic and diluted 640,578,794   586,351,045    640,578,794    586,347,645 



    Primary Logo

    View Full Article Hide Full Article
  35. MIAMI, July 27, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended June 30, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, July 30, 2020. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on July 30 beginning at 4:45 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 6946539. Upon registering, participants will receive dial-in numbers, an event passcode…

    MIAMI, July 27, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended June 30, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Thursday, July 30, 2020. OPKO's senior management will provide a business update and discuss results in greater detail during a conference call and live audio webcast on July 30 beginning at 4:45 p.m. Eastern time.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO encourages participants to pre-register for the conference call using the link here, or dialing (888) 869-1189 or (706) 643-5902 and using conference ID 6946539. Upon registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call.

    To access the live call via webcast, please click on the link OPKO 2Q20 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call's Q&A session are encouraged to listen to the call via the webcast.

    For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO's website at OPKO 2Q20 Results Conference Call.  A telephone replay will be available beginning approximately two hours after the close of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6946539.

    About OPKO Health

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  36. ELMWOOD PARK, N.J., July 20, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced it will accept an Indefinite Delivery Indefinite Quantity (IDIQ) contract award to provide Commercial Surge Capacity Testing for COVID-19 Emergency Response to the Centers for Disease Control and Prevention (CDC).

    Under the contract with the CDC, BioReference will perform antibody testing to determine COVID-19 seroprevalence, and will provide results with key demographic information and analysis in collaboration with the CDC. The agreement's period of performance began July 20, 2020, and is ongoing through November 19, 2020.

    "Working with the CDC underscores the importance of public, private partnership to achieve a worthwhile COVID-19 response," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Many studies suggest that the majority of the public has not been infected with COVID-19, but multiple factors limit these findings. Together with the leading public health authority, we are leveraging extensive depth and breadth of testing expertise to increase overall understanding of the disease burden of the virus."

    For more information, visit https://www.bioreference.com/coronavirus

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.

    About OPKO Health

    OPKO Health, Inc., is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit  www.opko.com.  

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19, the benefits of the contract with the CDC, the timing of and availability of the test, the expected daily capacity for testing, and the actual demand for our test, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-awarded-commercial-surge-capacity-testing-for-covid-19-emergency-response-contract-by-centers-for-disease-control-and-prevention-cdc-301096374.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  37. ELMWOOD PARK, N.J., July 13, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), will provide COVID-19 testing oversight for the National Basketball Association's (NBA) players and referees, as well as team and league staff participating in the NBA's season restart in Orlando.

    Under the agreement with the NBA, BioReference will provide COVID-19 testing, which includes PCR diagnostics, rapid diagnostics and antibody testing.

    The NBA and BioReference collaborated on testing protocols to provide the safest possible environment to restart the 2019-20 NBA season, going to extraordinary lengths to understand both the threats of the virus and the best means to control its spread. Testing protocols were established in consultation with infectious disease experts to ensure the safety of players and employees.

    "Collaborating with the National Basketball Association throughout the COVID-19 pandemic has been a privilege for BioReference," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The extensive, detailed and systematic protocols put in place by the NBA leadership highlights the priority they are placing on the overall safety of the NBA players, referees and other team and league staff, as well as their families. Similar to testing for employers trying to get their employees back to work, professional sports entertainment is another integral part of the everyday American experience. We are proud to be part of the solution that can help the nation return to normal."

    For more information, visit https://www.bioreference.com/coronavirus/employers-and-government-authorities/.    

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's antibody screening test, the availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of employees and customers, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-to-provide-covid-19-testing-for-national-basketball-association-players-and-employees-301091989.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  38. ELMWOOD PARK, N.J., July 9, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), will conduct COVID-19 testing for all Major League Soccer (MLS) players as well as match officials, and Club and League staff participating in the MLS is Back Tournament. MLS has chosen BioReference as its laboratory to assist in informing its return-to-play policies for the Tournament kicking off in Orlando in early July.

    In addition to providing testing to players, match officials, and staff, MLS is working with BioReference to provide COVID-19 antibody testing to the Orlando community. MLS is supporting the latest community collection location at the Orlando Vineland Premium Outlets, which began on July 6. The collection location is open Mondays through Saturdays from 8:00 AM to 6:00 PM ET.   

    "We are honored to be providing testing solutions to Major League Soccer as it prepares to restart its season," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The leadership of MLS worked diligently with us to develop a COVID-19 PCR and antibody testing strategy with the goal of providing the safest possible environment for the players, coaches and staff to begin to play again."

    For more information, visit https://www.bioreference.com/coronavirus/employers-and-government-authorities/.    

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's antibody screening test, the availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of employees and customers, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/major-league-soccer-chooses-opko-healths-bioreference-laboratories-to-provide-covid-19-testing-for-players-and-employees-301090547.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  39. ELMWOOD PARK, N.J., July 1, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the results of COVID-19 molecular PCR and antibody tests for nursing home and live-in facility employees.

    On May 10, New York State mandated that all personnel at nursing home and adult care facilities were to be tested for active COVID-19 infection using PCR-based molecular testing, twice per week. The personnel tested included all employees pursuant to a plan developed by the facility and filed with the Department of Health. At the start of the program, many nursing homes asked that employees be tested for antibodies at the same time. The majority of the nearly 3,500 antibody tests were performed within the…

    ELMWOOD PARK, N.J., July 1, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the results of COVID-19 molecular PCR and antibody tests for nursing home and live-in facility employees.

    On May 10, New York State mandated that all personnel at nursing home and adult care facilities were to be tested for active COVID-19 infection using PCR-based molecular testing, twice per week. The personnel tested included all employees pursuant to a plan developed by the facility and filed with the Department of Health. At the start of the program, many nursing homes asked that employees be tested for antibodies at the same time. The majority of the nearly 3,500 antibody tests were performed within the first two weeks of May. With 29% of employees testing positive for antibodies, an extrapolated estimate for the approximately 140,000 total nursing home staff in New York State suggests as many as 41,760 nursing home staff members in New York State could have had COVID-19 prior to early May.

    Test result summary:

    Overall 29.0% of nursing home employees tested positive for antibodies

    REGION

    TEST RESULTS

    POSITIVE

    % POSITIVE

    NYC

    376

    207

    55.1%

    WESTCHESTER/ROCKLAND

    450

    167

    37.1%

    LONG ISLAND

    1068

    378

    35.4%

    UPSTATE

    1594

    258

    16.2%

    STATEWIDE

    3488

    1010

    29.0%

    Overall 2.9% of employees tested positive for active infection (positive PCR)

    REGION

    TEST RESULTS

    POSITIVE

    % POSITIVE

    NYC

    73439

    3384

    4.60%

    WESTCHESTER/ROCKLAND

    29210

    901

    3.10%

    LONG ISLAND

    53371

    638

    1.20%

    UPSTATE

    65759

    1444

    2.20%

    STATEWIDE

    221779

    6367

    2.9%

    "Of the 3,500 nursing home staff that we tested, 29% were positive for antibodies. The very high positivity rate of antibodies in this employee group by early May would suggest that a significant number of nursing home employees had active COVID-19 disease early on in the outbreak. Although overall positivity rate for active infection is now low, over 6,000 employees were identified with active virus when we tested in May and June. By identifying these individuals, the mandatory testing program most likely prevented the further spread of the virus to thousands of vulnerable nursing home residents. Although it is impossible to calculate, many deaths had to have been prevented," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Throughout this unrelenting health crisis, BioReference has made it a priority to provide testing to those at an increased risk of COVID-19 infection, and we are proud of our efforts to help combat the spread of this virus."

    For more information, visit https://www.bioreference.com/coronavirus.  

    About BioReference Laboratories, Inc.

    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and an antibody test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit www.bioreference.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's antibody screening test, the availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of employees and customers, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-reports-results-of-covid-19-testing-for-almost-one-quarter-of-a-million-nursing-home-and-live-in-facility-employees-301086786.html

    SOURCE BioReference Laboratories, Inc.

    View Full Article Hide Full Article
  40. MIAMI, June 09, 2020 (GLOBE NEWSWIRE) -- Following last October's announcement of successful results of the global Phase 3 study of once-weekly somatrogon, an investigational agent for the treatment of pediatric growth hormone deficiency (pGHD), OPKO Health Inc. (NASDAQ:OPK) announced today that the Japan Phase 3 clinical trial met its primary and secondary objectives, and demonstrated that the efficacy and safety of somatrogon administered weekly was comparable to GENOTROPIN® (somatropin) for injection administered once-daily as measured by annual height velocity after 12 months of treatment in treatment-naïve Japanese pre-pubertal children with GHD. The findings were consistent with the results previously reported in the Phase 3 global study…

    MIAMI, June 09, 2020 (GLOBE NEWSWIRE) -- Following last October's announcement of successful results of the global Phase 3 study of once-weekly somatrogon, an investigational agent for the treatment of pediatric growth hormone deficiency (pGHD), OPKO Health Inc. (NASDAQ:OPK) announced today that the Japan Phase 3 clinical trial met its primary and secondary objectives, and demonstrated that the efficacy and safety of somatrogon administered weekly was comparable to GENOTROPIN® (somatropin) for injection administered once-daily as measured by annual height velocity after 12 months of treatment in treatment-naïve Japanese pre-pubertal children with GHD. The findings were consistent with the results previously reported in the Phase 3 global study.

    Using the Full Analysis Set, the least squared means for the annual height velocity was higher in the somatrogon group (9.65 cm/year) than in the GENOTROPIN group (7.87 cm/year). The point estimate of the treatment difference was 1.79 cm/year with the two-sided 95% confidence interval of (0.97, 2.60). Similarly, greater change in height standard deviation score from baseline at 12 months was observed for the somatrogon group (0.94) compared to the GENOTROPIN group (0.52), indicating that both somatrogon and GENOTROPIN were associated with catch-up growth in treated patients.

    Most adverse events were mild to moderate in severity with no notable differences between the treatment groups, and weekly somatrogon administration was generally well-tolerated. A total of six serious adverse events were reported in four patients (two in the somatrogon arm and two in the GENOTROPIN arm). One patient in the GENOTROPIN group discontinued treatment in the study due to adverse events.

    "We are pleased to announce positive top-line results from the Japanese Phase 3 clinical study of somatrogon. We have reached an additional clinical development milestone of somatrogon with the demonstration of comparable efficacy and safety of somatrogon administered once-weekly to daily administration of GENOTROPIN in pediatric patients with growth hormone deficiency," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "Positive results in both the Japanese and pivotal global Phase 3 pediatric trials are promising for children with pGHD. Treatment with once-weekly somatrogon represents a significant advance, which has the potential to enhance patient adherence and quality of life."

    "The data from the Japan Phase 3 trial are very encouraging and point to the potential of bringing a once-weekly treatment option to children with pGHD. We are committed to furthering treatment advances for people living with rare growth hormone disorders and this is an exciting advance that may help ease the daily disease burden for children and their caregivers," said Brenda Cooperstone, M.D., Chief Development Officer, Rare Disease, Pfizer Global Product Development.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product. The companies will evaluate the potential for additional pediatric and adult indications, as appropriate.

    About the Study

    The Phase 3 study of somatrogon in 44 treatment-naïve Japanese pre-pubertal children with pGHD was a 12-month, open-label, randomized, active-controlled, parallel-group study of the efficacy and safety of weekly somatrogon compared to recombinant human growth hormone (r-hGH), GENOTROPIN® (somatropin) for injection treatment administered once-daily. Eligible patients were randomized in a 1:1 ratio to receive either once-weekly somatrogon or GENOTROPIN administered once-daily (reference therapy, 0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week). To obtain pharmacokinetic information of three different weekly doses in Japanese pGHD patients, somatrogon treated patients received 0.25 mg/kg/week for 2 weeks, followed by 0.48 mg/kg/week for 2 weeks followed by 0.66 mg/kg/week for the remaining 46 weeks.  Somatrogon was administered subcutaneously using a single patient use, multi-dose, disposable, pre-filled pen, the same pen used in the global study, while GENOTROPIN was administered using approved commercial products in Japan.

    Patients who completed the 12-month Main Study Period and met the inclusion criteria were given the opportunity to continue in a long-term open label extension period with once-weekly somatrogon until marketing approval. All patients in the GENOTROPIN group have been switched to weekly somatrogon treatment.

    About Somatrogon

    Somatrogon is a new molecular entity that contains the natural sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic hCG at the N-terminus and two copies at the C-terminus. The CTPs extend the half-life of the molecule. Somatrogon received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood and may experience other health problems.

    About GENOTROPIN®

    GENOTROPIN is a recombinant growth hormone as a replacement treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved in the United States to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs.  GENOTROPIN is distributed by Pharmacia and Upjohn Co., a division of Pfizer, Inc.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This release contains forward-looking information about a product candidate, somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (or GHD), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for somatrogon; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; and competitive developments.

    A further description of risks and uncertainties can be found in OPKO's Annual Reports on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results", "Cautionary Statement Regarding Forward-Looking Statements", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.OPKO.com.

    Contacts:

    LHA Investor Relations

    Yvonne Briggs, 310-691-7100



    or

    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  41. MIAMI, June 01, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for patients with mild-to-moderate COVID-19.  The trial, entitled "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease (CKD).

    The REsCue trial will have 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up.  The objective is to raise and maintain serum total 25-hydroxyvitamin…

    MIAMI, June 01, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE® as a treatment for patients with mild-to-moderate COVID-19.  The trial, entitled "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue)," is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease (CKD).

    The REsCue trial will have 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up.  The objective is to raise and maintain serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL in order to mitigate COVID-19 severity.

    "Raising serum 25D enables macrophages, a type of white blood cell of the immune system, to secrete potent antiviral proteins that can destroy SARS-CoV-2, the virus that causes COVID-19," explained Charles W. Bishop, PhD, CEO of OPKO's Renal Division.  "It also can suppress the cytokine storm triggered by viral infection."

    COVID-19 disproportionately afflicts patients with obesity, older age, darker skin or CKD, all of which are risk factors for reduced serum 25D. Raising 25D sufficiently with supplements is difficult.

    About RAYALDEE®

    RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.  The product is the first and only medicine approved by the U.S. FDA for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE, approved to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in November 2016. 

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "could," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including product development efforts and the expected benefits of RAYALDEE, whether and when we will initiate and complete the clinical studies contemplated for RAYALDEE and whether final study data will be positive, our ability to develop and commercialize RAYALDEE for COVID-19 patients, whether RAYALDEE is capable of treating patients with COVID-19, impacting the SARS-CoV-2 virus or cytokine storm, or have any impact on the severity of the disease or that it will effectively raise and maintain serum total 25D consistently at or above 50ng/mL, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects.  Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners for RAYALDEE, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    CONTACTS:
    Investors
    LHA Investor Relations
    Yvonne Briggs, 310-691-7100

    or
    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  42. NEW YORK, May 18, 2020 /PRNewswire/ -- MagnaCare today announced a collaboration with BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), to bring COVID-19 antibody testing to their Labor clients in the New York metropolitan area. Through this collaboration with BioReference, MagnaCare will offer on-site antibody blood testing to Labor members, delivering valuable information as the city, employers and individuals plan return-to-work strategies.

    "As New York's coronavirus outbreak has continued to unfold, our Labor partners have been eager for information and guidance on COVID-19 antibody testing — particularly since skilled trade groups will be among the first to return-to-work and begin re-energizing the local economy…

    NEW YORK, May 18, 2020 /PRNewswire/ -- MagnaCare today announced a collaboration with BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), to bring COVID-19 antibody testing to their Labor clients in the New York metropolitan area. Through this collaboration with BioReference, MagnaCare will offer on-site antibody blood testing to Labor members, delivering valuable information as the city, employers and individuals plan return-to-work strategies.

    "As New York's coronavirus outbreak has continued to unfold, our Labor partners have been eager for information and guidance on COVID-19 antibody testing — particularly since skilled trade groups will be among the first to return-to-work and begin re-energizing the local economy," said MagnaCare President Michelle Zettergren. "Antibody testing can support decision making about back-to-work procedures and safety measures for protecting workers and the public. We're proud to bring this service to our clients so they have more knowledge, and hopefully some peace of mind, in this challenging environment."

    BioReference Laboratories, which recently worked with New York State and New York City to provide COVID-19 antibody testing, offers a blood test that measures SARS-CoV-2 specific antibody levels to help determine an individual's immune response after COVID-19 infection. Although the presence of antibodies are typically associated with immunity, the scientific community is still working to understand what level of antibodies might be needed for protection from reinfection with COVID-19, and how long that protection might last.

    The collaboration will begin with on-site testing for the District Council 9 of the International Union of Painters and Allied Trades (IUPAT) on May 18-20. The on-site testing is available to DC 9 members, who must go online to pre-register and schedule their test. The cost will be fully covered by the union, and results will be emailed directly to members within 72 hours.

    "Our goal is to get our members back to work with comfort and confidence," said Joseph Azzopardi, Business Manager and Secretary Treasurer of DC 9. "We're grateful to MagnaCare for providing a convenient testing option so we can all decide how best to move forward in the days and weeks ahead."

    MagnaCare is also working with some of its other New York-based Labor partners to establish additional on-site testing locations this month.

    About MagnaCare
    For more than 25 years, MagnaCare has been building healthy communities together with Taft-Hartley funds, TPAs, carriers, and workers' compensation and no-fault payors in the New York, New Jersey, and Connecticut tristate area. Its broad and wholly owned network, full health plan management services, comprehensive in-house medical management, and leading outcomes-based casualty solutions offer the ultimate flexibility and customization that help customers control health care costs, improve health, and achieve exceptional value. MagnaCare is a division of Brighton Health Plan Solutions, LLC

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

    Media Contact for MagnaCare:
    Erin George
     
    615-946-9914

    Media Contact for BioReference Laboratories:
    Hillary Titus

    201-406-9968

    Cision View original content:http://www.prnewswire.com/news-releases/magnacare-and-bioreference-laboratories-bring-covid-19-antibody-testing-to-new-york-labor-groups-301060258.html

    SOURCE Brighton Health Plan Solutions

    View Full Article Hide Full Article
  43. ELMWOOD PARK, N.J., May 13, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today launched the BioReference Employer Solution, a COVID-19 screening program that assists employers' decisions about return-to-work policies.

    Test results play a critical role in the fight against COVID-19 by identifying who has detectable antibodies, and providing the amount of antibodies measured. Combining other clinical information and guidance from health authorities, these results can inform decisions on enhancing the safety of employees and customers. 

    To support return-to-work strategies and COVID-19 antibody screening efforts, BioReference is offering flexible specimen collection options tailored to each employer, including a plug-and-play program in a designated location for employees or at one of BioReference's large pop-up sites. The first pop-up site will open at the Livingston Mall in Livingston, New Jersey, beginning on May 15.

    Livingston Mall COVID-19 Testing Location:
    112 Eisenhower Parkway, Livingston, NJ 07039
    In the parking lot between Lord & Taylor and Macy's
    Mondays through Saturdays beginning May 15, 2020
    8AM6PM ET

    The BioReference Employer Solution provides digital registration and check-in, onsite testing and processing, and online result access. BioReference can tailor the offering of testing depending on an organization's size and preference, which can include site identification and set-up services, and phlebotomy services. 

    "For employers, COVID-19 screening for antibodies is one additional piece of information to help guide decisions about moving forward," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Antibody testing can provide employers key information about who might have been exposed or infected, and who may potentially be immune from re-infection. It's our responsibility to add to the body of knowledge for this virus, and we believe antibody screening can be helpful to guide us toward a new normal."

    For more information, visit https://www.bioreference.com/coronavirus/employers-and-government-authorities/.    

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit https://www.bioreference.com.

    About OPKO Health, Inc.
    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's antibody screening test, the availability of the test and the role and value of the information provided and its impact on decisions relative to the safety of employees and customers, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-covid-19-employer-solution-301058864.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  44. ELMWOOD PARK, N.J., May 13, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a strategic collaboration with the Westchester Medical Center Health Network (WMCHealth), a 1,700-bed healthcare system headquartered in Valhalla, New York, to provide full laboratory administrative services, laboratory operations, reference testing and outpatient laboratory services.

    WMCHealth has 10 hospitals on eight campuses spanning 6,200 square miles of the Hudson Valley, including Westchester Medical Center, Maria Fareri Children's Hospital, Behavioral Health Center, Bon Secours Community Hospital, Good Samaritan Hospital, HealthAlliance, Margaretville Hospital, MidHudson Regional Hospital and St. Anthony Community Hospital. WMCHealth performs over seven million laboratory tests per year.

    Under the agreement, BioReference will provide administrative services, laboratory equipment, supplies and procurement processes initially for Westchester Medical Center, in addition to immediately providing reference testing and outreach for the entire hospital network. This collaboration allows healthcare providers and patients of WMCHealth expanded access to analytics tools, scientific expertise, and patient experience platforms, resulting in improved patient outcomes.

    "At WMCHealth, our commitment is to provide the finest and most advanced care and services to the communities we serve," said Michael D. Israel, President and CEO of WMCHealth. "We are continually looking for partners that enable us to tailor solutions and match our commitment to deliver high-quality services to patients. Our agreement with BioReference enables us to offer a consistent and cohesive level of care through our laboratories for the patients seen at Westchester Medical Center and throughout WMCHealth each year."

    "Leading health systems are prioritizing their business operations and are leveraging partners such as BioReference to support operations, evaluate and execute their laboratory strategy, allowing them to focus on their patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "This collaboration reinforces our model of delivering industry-leading diagnostic services to partners across the country."

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine. For more information, visit https://www.bioreference.com.

    About OPKO Health, Inc.
    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected benefits of our collaboration with WMC Health, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-and-westchester-medical-center-health-network-enter-into-strategic-laboratory-collaboration-to-deliver-operational-and-diagnostic-services-301058235.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  45. ELMWOOD PARK, N.J., May 8, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced the launch of COVID-19 antibody screening available to New York City residents in partnership with New York City Health and Hospital Corporation (NYC Health + Hospitals). Testing will initially be performed for 140,000 residents at five locations across all five boroughs, with more testing sites to open in the next several weeks. Test results will be available through BioReference's Patient Portal, accessible by smartphone, tablet, desktop or traditional US Mail and become available within 1-3 days, on average.

    "So many New Yorkers are wondering whether they've had the virus, or if they've exposed their own families," said Mayor Bill de Blasio during a press announcement. "While antibody tests are not a fix-all solution, they will give our communities the knowledge they need to help us defeat this virus together."

    "BioReference is supporting the city in its epidemiology studies of the presence of COVID-19 throughout large segments of the New York City population," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "For New York, a city that has been seriously impacted by the COVID-19 pandemic, this type of information will be of great value in helping healthcare professionals to analyze the presence and progression of the disease in order to identify at risk populations for possible early intervention." 

    Antibody screening is not intended to detect an active COVID-19 infection and individuals experiencing symptoms of an active COVID-19 infection should not visit these screening sites, which are not equipped to collect respiratory specimens for molecular COVID-19 diagnostic testing. Individuals experiencing COVID-19 symptoms are encouraged to contact their healthcare providers.

    For more information, visit https://www.bioreference.com/coronavirus.

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.

    About OPKO Health
    OPKO Health, Inc., is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's antibody screening test, the availability of the test and the turnaround time for test results, the expected daily capacity for testing, and the actual demand for our test, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-launches-covid-19-antibody-screening-for-new-york-city-residents-301055507.html

    SOURCE BioReference Laboratories, Inc.

    View Full Article Hide Full Article
  46. MIAMI, May 06, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended March 31, 2020.

    Business Highlights

    • BioReference Laboratories launched COVID-19 testing nationwide:  On March 13, 2020, BioReference Laboratories launched a Real-Time Reverse Transcription Polymerase Chain Reaction assay with an approximate 24-72 hour turnaround time to promote earlier diagnosis of the SARS-CoV-2 virus to aid in limiting the spread of infection. In addition to its nationwide COVID-19 test offering, BioReference announced testing partnerships with the New York State Department of Health, New York City Health and Hospital Corporation, the State of New Jersey, the State of Florida…

    MIAMI, May 06, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) reports business highlights and financial results for the three months ended March 31, 2020.

    Business Highlights

    • BioReference Laboratories launched COVID-19 testing nationwide:  On March 13, 2020, BioReference Laboratories launched a Real-Time Reverse Transcription Polymerase Chain Reaction assay with an approximate 24-72 hour turnaround time to promote earlier diagnosis of the SARS-CoV-2 virus to aid in limiting the spread of infection. In addition to its nationwide COVID-19 test offering, BioReference announced testing partnerships with the New York State Department of Health, New York City Health and Hospital Corporation, the State of New Jersey, the State of Florida and the cities of Detroit and Miami, among others. Additionally, Rite Aid Corporation selected BioReference to provide COVID-19 laboratory testing to its drive-up locations with the goal of flattening the curve through widely accessible diagnostic testing. To date, BioReference has run approximately 700,000 COVID-19 tests and currently has a COVID-19 testing capacity of 35,000 tests per day. As of April 27, 2020, BioReference Laboratories started offering COVID-19 antibody testing, a semi-quantitative immunoassay that measures SARS-CoV-2 specific IgG antibody levels, correlating with the patient's immune response after COVID-19 infection.  Within the next two weeks, BioReference expects to expand its capacity to be able to process up to 400,000 tests per day.
       
    • Somatrogon abstract to be presented at Endocrine Society's ENDO Online 2020:  On April 22, 2020, OPKO announced the data from its two abstracts regarding the global Phase 3 pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency will be combined into a single presentation at ENDO Online 2020, a virtual event being held June 8 through 22 featuring on-demand and live programming. The results of the pivotal Phase 3 study will be delivered on June 8, 2020 at 11:00 a.m. Eastern time by Dr. Cheri Deal, the Principal Investigator of the pediatric study.  The two abstracts entitled "Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency:  Results of the Pivotal Phase 3" and "Interpretation of Insulin-like Growth Factor (IGF-1) Levels Following Administration of Somatrogon (a long-acting Growth Hormone-hGH-CTP)" will be published online in the April-May supplemental issue of the Journal of Endocrine Society.
       
    • Somatrogon global regulatory submissions:  Somatrogon regulatory submission in the U.S. is anticipated to occur in the second half of 2020.  In Europe, regulatory submission will follow completion of the open-label study demonstrating benefit and compliance with reduced treatment burden, which is expected to be completed in the third quarter of 2020. The registration study in Japan for pediatric growth hormone deficiency patients was completed in early March and topline data is expected in mid-2020.
       
    • RAYALDEE total prescriptions reported by IQVIA increased 78% in the first quarter of 2020 compared with the first quarter in 2019:  Total prescriptions for the three months ended March 31, 2020 increased to approximately 18,327, compared with approximately 10,307 during the comparable period of 2019.
       
    • Interim results from two ongoing RAYALDEE studies reported:  On March 25, 2020, OPKO announced positive preliminary data from the ongoing Phase 4 comparative trial, which suggest that RAYALDEE may be more effective in raising serum total 25-hydroxyvitamin D to the level required to effectively suppress elevated plasma intact parathyroid hormone (iPTH) in stage 3 or 4 chronic kidney patients.  Final results are expected in the second half of 2020. In addition, OPKO announced positive proof-of-concept data from the ongoing Phase 2 trial in patients with stage 5 chronic kidney disease demonstrating RAYALDEE may be useful in treating secondary hyperparathyroidism in dialysis patients. The Phase 2 trial in hemodialysis patients is on track to complete enrollment in the third quarter of 2020 with full topline data expected in the first quarter of 2021.
       
    • Nearly 16,000 4Kscore® tests performed during the first quarter of 2020: Novitas Solutions issued its final Local Coverage Determination for Medicare payments for the 4Kscore test with defined coverage criteria, effective December 30, 2019.  With Medicare reimbursement in place, the Company began its salesforce expansion for the 4Kscore during the first quarter of 2020; however, COVID-19 impacted utilization during the month of March. 

    Financial Results

    • Consolidated revenues for the first quarter of 2020 were $211.5 million compared with $222.5 million for the comparable period of 2019.  The net loss for the first quarter of 2020 was $59.1 million, or $0.09 per share, compared with a net loss of $80.8 million, or $0.14 per share, for the comparable period of 2019.   
       
    • Diagnostics:  Revenue from services in the first quarter of 2020 was $170.8 million compared with $178.9 million for the comparable period in 2019. Although revenue from services was positively affected by increased reimbursement amounts and improved operational procedures, in the last two weeks of March 2020, the Company experienced a decline in testing volumes net of COVID-19 testing services due to the COVID-19 pandemic. Total costs and expenses were $189.0 million in the first quarter of 2020 compared with $212.5 million for the comparable period in 2019 with the reduction primarily attributable to lower selling, general and administrative expenses due to cost-reduction initiatives. In addition, the 2019 period included a $10.6 million legal accrual.  As a result, operating loss was $18.1 million in the first quarter of 2020 compared with $33.6 million in the first quarter of 2019.
       
    • Pharmaceuticals: Revenue from products in the first quarter of 2020 was $31.1 million compared with $25.3 million in the first quarter of 2019 with the increase primarily attributable to higher sales of RAYALDEE of $9.9 million in the first quarter of 2020 compared with $5.8 million in the prior year period. Revenue from licensing and intellectual property was $9.6 million in the first quarter of 2020 compared to $18.3 million in the first quarter of 2019 with the reduction primarily due to a decrease in the amortization of payments received from Pfizer, OPKO's commercial partner for its long-acting human growth hormone product, Somatrogon. Total cost and expenses were $54.8 million in the first quarter of 2020 compared with $73.0 million for the prior year period, with the decline primarily attributable to lower research and development expenses due to the completion of the pediatric Phase 3 study for somatrogon. The operating loss was $14.1 million in the first quarter of 2020 compared to $29.5 million in the first quarter of 2019.

    • Cash and equivalents: Cash, cash equivalents and marketable securities were $34.5 million as of March 31, 2020.   In addition, the Company has an unutilized $100 million credit facility which provides the company with access to incremental capital on a non-dilutive basis.  In April 2020, the Company also accessed additional capital available under the CARES Act which provided the company with approximately $30 million of short-term liquidity through various provisions under the Act.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today, May 6, 2020. The conference call dial-in and webcast information is as follows:

    DOMESTIC DIAL-IN:   (877) 783-8475 
    INTERNATIONAL DIAL-IN:   (614) 999-1827
    PASSCODE:   9095275
    WEBCAST:   OPKO 1Q20 Results Conference Call

    For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 9095275. The replay can be accessed for a period of time on OPKO's website at OPKO 1Q20 Results Conference Call.

    About OPKO Health

    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad. 

    Cautionary Statement Regarding Forward Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, expectations about COVID-19 testing, our capacity for testing and expected turnaround time, our ability to expand our capacity to be able to process up to 400,000 antibody tests per day, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, the possibility of unfavorable new clinical data and further analyses of existing clinical data, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities, whether regulatory authorities will be satisfied with the design of and results from our clinical studies, whether the two Rayaldee studies or our other ongoing and future clinical trials will be successfully enrolled or completed on a timely basis or at all and whether the data from any of our trials will support submission or approval, validation and/or reimbursement for our products, whether RAYALDEE prescriptions will continue to increase, expectations regarding timing for commencing and concluding our clinical trials and releasing data, the timing of our regulatory submissions, including for somatrogon, our ability to market and sell any of our products in development, and expectations about developing RAYALDEE for dialysis patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading "Risk Factors" in our other filings with the Securities and Exchange Commission, as well as the ongoing effects of the COVID-19 pandemic, the continuation and success of our relationship with Pfizer and our other partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that somatrogon, the 4Kscore, RAYALDEE, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations
    Yvonne Briggs, 310-691-7100

    or
    Bruce Voss, 310-691-7100
     

    —Tables to Follow—



    OPKO Health, Inc. and Subsidiaries
    Condensed Consolidated Balance Sheets (Unaudited)
    (in millions)

      As of
      March 31,
    2020
      December 31,
    2019
    Assets:              
      Cash, cash equivalents and marketable securities $ 34.5     $ 85.5  
      Other current assets   239.9       238.5  
    Total Current Assets   274.4       324.0  
    In-process Research and Development and Goodwill   1,259.8       1,262.1  
    Other assets   698.3       723.2  
      Total Assets $ 2,232.5     $ 2,309.3  
                   
    Liabilities and Equity:              
      Current liabilities $ 245.1     $ 249.1  
      Convertible Notes   213.8       211.2  
      Deferred tax liabilities, net   118.6       118.7  
        Other long-term liabilities, principally contract liabilities, contingent consideration and lines of credit   106.4       115.5  
      Total Liabilities   683.9       694.5  
      Equity   1,548.6       1,614.8  
      Total Liabilities and Equity $ 2,232.5     $ 2,309.3  
     
     

    OPKO Health, Inc. and Subsidiaries
    Condensed Consolidated Statements of Operations (Unaudited)
    (in millions, except share and per share data)

      For the three months ended
    March 31, 
      2020    2019 
    Revenues  
    Revenue from services   $ 170.8     $ 178.9  
    Revenue from products     31.1       25.3  
    Revenue from transfer of intellectual property     9.6       18.3  
    Total revenues     211.5       222.5  
    Costs and expenses              
    Cost of revenues     140.3       144.0  
    Selling, general and administrative     76.1       95.2  
    Research and development     21.8       36.5  
    Contingent consideration     (0.9 )     4.8  
    Amortization of intangible assets     14.9       16.6  
    Asset impairment charges     0.0       0.7  
    Total Costs and expenses     252.2       297.8  
    Operating loss     (40.7     (75.3 )
    Other income and (expense), net     (17.1     (2.8 )
    Loss before income taxes and investment losses     (57.8     (78.1 )
    Income tax provision     (1.2     (0.8 )
    Loss before investment losses     (59.0     (78.9 )
    Loss from investments in investees     (0.1     (1.9 )
    Net loss   $ (59.1   $ (80.8 )
    Loss per share, basic and diluted   $ (0.09   $ (0.14 )
    Weighted average common shares outstanding, basic and diluted      640,578,794        586,344,207  

    Primary Logo

    View Full Article Hide Full Article
  47. MIAMI, April 30, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended March 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Wednesday, May 6, 2020.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, May 6, 2020. The conference call dial-in and webcast information is as follows:

    DOMESTIC DIAL-IN:
    INTERNATIONAL DIAL-IN:
    PASSCODE:
    WEBCAST:
          (877) 783-8475
    (614) 999-1827
    9095275
    OPKO 1Q20 Results Conference Call
         

    For those unable to participate in the…

    MIAMI, April 30, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) plans to report operating and financial results for the three months ended March 31, 2020, as well as discuss financial guidance, after the close of the U.S. financial markets on Wednesday, May 6, 2020.

    CONFERENCE CALL & WEBCAST INFORMATION

    OPKO's senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, May 6, 2020. The conference call dial-in and webcast information is as follows:

    DOMESTIC DIAL-IN:
    INTERNATIONAL DIAL-IN:
    PASSCODE:
    WEBCAST:
          (877) 783-8475
    (614) 999-1827
    9095275
    OPKO 1Q20 Results Conference Call
         

    For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 9095275. The replay can be accessed for a period of time on OPKO's website at OPKO 1Q20 Results Conference Call.

    About OPKO Health

    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad. 

    Contacts:

    LHA Investor Relations
    Yvonne Briggs, 310-691-7100

    or
    Bruce Voss, 310-691-7100

    Primary Logo

    View Full Article Hide Full Article
  48. ELMWOOD PARK, N.J., April 29, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), announced that beginning today it will offer antibody blood tests to detect an immune response after infection with the COVID-19 virus. Antibody testing and molecular diagnostic testing for COVID-19 are available to healthcare providers nationwide. In addition, under an agreement with New York State, BioReference will begin testing thousands of people per day for COVID-19 antibodies, starting today with MTA employees.

    BioReference began antibody testing last week with a focus on testing its employees. This week, BioReference launches COVID-19 antibody testing nationwide and is working expeditiously to be able to test 400,000 patients per day by mid-May.

    "Testing for antibodies is the next logical step to help employers and employees countrywide make decisions as to how to move forward with their jobs and personal lives," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "We are proud to partner with New York State to identify employees' antibody levels and areas of the population with varying levels of antibodies, types of populations that may be at a higher risk of infection, individuals who may be possible plasma donors of convalescent serum and data that can be helpful when deciding on how to roll out a vaccine when it becomes available."

    BioReference is offering a semi-quantitative immunoassay that measures SARS-CoV-2 specific antibody levels to determine the patient's immune response after COVID-19 infection. While antibody tests are helpful to understand if an individual has developed antibodies and a potential immune response, antibody testing should not be used as the sole basis to diagnose or exclude infection. Test results should be interpreted in connection with other factors, such as symptoms and history. Results signify that antibodies are present, but protective immunity based on these results has yet to be established in clinical trials.

    Blood antibody tests offered by BioReference are performed on high-throughput instruments, have been validated for sensitivity and specificity, have been reviewed by appropriate state Departments of Health and are registered with the U.S. Food and Drug Administration (FDA).

    Specimens will be accepted from physician offices, hospitals, other clinic settings and officially sanctioned screening programs.

    For more information, visit https://www.bioreference.com/coronavirus.

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.

    About OPKO Health
    OPKO Health, Inc., is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity to 400,000 tests per day, our ability to increase COVID 19 testing availability nationwide, as well as the timeline for doing so, the actual demand for our test, the number of New York residents which may be tested under the terms of the agreement with New York State, the viability, sensitivity, specificity and utility of our antibody test and whether a positive antibody test indicates any immunity against re-infection, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-in-partnership-with-new-york-state-initiates-testing-for-covid-19-antibodies-301049559.html

    SOURCE BioReference Laboratories, Inc.

    View Full Article Hide Full Article
  49. MIAMI, April 22, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:  OPK) today provided an update on two abstracts regarding the global Phase 3 somatrogon pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (GHD).  The data from the two abstracts, which were previously accepted for oral presentation at the Endocrine Society's (ENDO) 2020 meeting, will now be combined into a single presentation at ENDO Online 2020, a virtual event being held June 8 through 22 that will feature on-demand and live programming. The virtual event will incorporate select content from the ENDO 2020 meeting previously scheduled for March 29 through 30 in San Francisco, which was cancelled due to the COVID-19…

    MIAMI, April 22, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:  OPK) today provided an update on two abstracts regarding the global Phase 3 somatrogon pediatric trial evaluating somatrogon dosed once weekly in pre-pubertal children with growth hormone deficiency (GHD).  The data from the two abstracts, which were previously accepted for oral presentation at the Endocrine Society's (ENDO) 2020 meeting, will now be combined into a single presentation at ENDO Online 2020, a virtual event being held June 8 through 22 that will feature on-demand and live programming. The virtual event will incorporate select content from the ENDO 2020 meeting previously scheduled for March 29 through 30 in San Francisco, which was cancelled due to the COVID-19 outbreak. 

    The results of the pivotal Phase 3 study will be delivered on June 8, 2020 at 11:00 a.m. Eastern time by Dr. Cheri Deal, the Principal Investigator of the Pediatric study.  The presentation will be available to those registered for ENDO Online 2020.

    The two abstracts entitled "Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency:  Results of the Pivotal Phase 3" and "Interpretation of Insulin-like Growth Factor (IGF-1) Levels Following Administration of Somatrogon (a long-acting Growth Hormone-hGH-CTP)" will be published online in the April-May supplemental issue of the Journal of Endocrinology Society.

    On October 21, 2019, OPKO Health and Pfizer Inc. announced that the global Phase 3 trial met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

    About OPKO Health, Inc.
    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects, as well as statements about expected benefits of hGH-CTP. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Contacts:

    LHA Investor Relations
    Yvonne Briggs, 310-691-7100

    or
    Bruce Voss, 310-691-7100

     

    Primary Logo

    View Full Article Hide Full Article
  50. ELMWOOD PARK, N.J., April 6, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced that it will continue to prioritize COVID-19 testing for hospital inpatients and critically ill patients around the country.

    "Our goal is to maintain the current 24 hour turnaround time for these patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Nothing is more important than getting a timely result back to the medical personnel on the front lines making treatment decisions on a minute-to-minute basis."

    "Multiple types of hospitals, for-profit, not-for-profit, large health systems, individual hospitals, academic medical centers, and community hospitals have all reached out to get their results in a timely fashion. We have now tested almost 200,000 patients and will continue to grow our capacity from 20,000 tests/day to 35,000 tests/day within the next week. While prioritizing hospital patients, at the same time we will continue to strive to keep our current turnaround time for non-hospital patients at 2-3 days from the time we receive the specimen," said Dr. Cohen.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html

    About COVID-19 Testing at BioReference Laboratories, Inc.
    BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey, the State of Florida and the cities of Detroit and Miami to provide COVID-19 testing.

    BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-72 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 20,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.  

    About OPKO Health
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity and the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-partners-with-hospitals-nationwide-to-provide-prioritized-testing-to-inpatients-with-suspected-coronavirus-disease-2019-covid-19-301035608.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  51. Insider buying can be an encouraging signal for potential investors.

    A number of insiders made return trips to the buy windows last week.

    Resort and railroad operators were among those seeing insider buying.

    Conventional wisdom says that insiders and 10% owners really only buy shares of a company for one reason — they believe the stock price will rise and they want to profit. So insider buying can be an encouraging signal for potential investors, particularly during periods of uncertainty.

    Insiders continued to take advantage of fallen share prices last week. The following are some of the most noteworthy insider purchases reported in the past week.

    A pair of beneficial owners took advantage of a direct offering to add a total…

    Insider buying can be an encouraging signal for potential investors.

    A number of insiders made return trips to the buy windows last week.

    Resort and railroad operators were among those seeing insider buying.

    Conventional wisdom says that insiders and 10% owners really only buy shares of a company for one reason — they believe the stock price will rise and they want to profit. So insider buying can be an encouraging signal for potential investors, particularly during periods of uncertainty.

    Insiders continued to take advantage of fallen share prices last week. The following are some of the most noteworthy insider purchases reported in the past week.

    A pair of beneficial owners took advantage of a direct offering to add a total of 955,500 or so Carvana Co (NASDAQ:CVNA) shares. At $45 per share, that cost them around $43 million. The used car company said it raised money for a restructuring effort.

    MGM Resorts International (NYSE:MGM) saw President William Hornbuckle and other insiders pick up almost 2.2 million shares for $10.60 to $12.35 each. That totaled over $25.51 million. Hornbuckle's stake is up to over 148,700 shares.

    Virginia-based tech company Appian Corp (NASDAQ:AAPN) saw a beneficial owner return to the buy window. At prices ranging from $35 to $42 for 384,400 or so shares, the latest purchases added up to more than $14.75 million.

    A director sold 8,000 shares last week too.

    A director at SYNNEX Corporation (NYSE:SNX) bought 52,000 shares of this IT services company, and a 10% owner also added 50,000 shares. At $73.10 to $74.47 per share, that came to more than $7.57 million altogether. Note that the chief financial officer sold less than 300 shares as well.

    A director of HD Supply Holdings Inc (NASDAQ:HDS) indirectly purchased over 308,700 shares of this Atlanta-based industrial distributor at between $25.76 and $26.98 each. That totaled nearly $7.02 million. That director also bought more than 314,000 shares last month.

    A Union Pacific Corporation (NYSE:UNP) director shelled out $138.20 each for 15,000 shares of this Omaha-based railroad operator. That cost him more than $2.07 million and was pursuant to a Rule 10b5-1 trading plan.

    Opko Health Inc. (NASDAQ:OPK) CEO Phillip Frost, a frequent buyer, indirectly purchased almost 1.13 million shares of this biotech at $1.14 to $1.35 each. That totaled more than $1.59 million. Frost also added 300,000 shares the prior week.

    An executive acquired almost 9,800 Baxter International Inc (NYSE:BAX) shares last week, and a pair of directors sold some shares of this health care company. That buyer paid $82.09 to $82.25 per share, which cost him more than $803,800.

    An Energy Transfer LP (NYSE:ET) director acquired some shares of this master limited partnership recently. At about $4.88 each, the 120,000 shares added up to more than $586,900. A number of insiders were buyers throughout March.

    See also: Bulls And Bears Of The Week: Amazon, Boeing, Microsoft, Twitter And More

    In addition, note that there was some recent insider buying at Cracker Barrel Old Country Store, Inc. (NASDAQ:CBRL) and Schlumberger Limited. (NYSE:SLB).

    At the time of this writing, the author had no position in the mentioned equities.

    Keep up with all the latest breaking news and trading ideas by following Benzinga on Twitter.

    View Full Article Hide Full Article
  52. Phase 4 Head-to-Head Study in Patients with Stage 3 or 4 Chronic Kidney Disease 
    Phase 2 Trial in Patients with Stage 5 Chronic Kidney Disease on Dialysis

    MIAMI, March 25, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today reported interim results from an ongoing Phase 4 clinical trial comparing RAYALDEE® with three common treatment regimens for secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, as well as interim results from an ongoing Phase 2 clinical trial exploring the safety and efficacy of a high-strength formulation of RAYALDEE as a new treatment for SHPT in adult patients with stage 5 CKD requiring hemodialysis and vitamin D insufficiency. 

    Phase 4 Head-to-Head Study in Patients with Stage 3 or 4 Chronic Kidney Disease 
    Phase 2 Trial in Patients with Stage 5 Chronic Kidney Disease on Dialysis

    MIAMI, March 25, 2020 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today reported interim results from an ongoing Phase 4 clinical trial comparing RAYALDEE® with three common treatment regimens for secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, as well as interim results from an ongoing Phase 2 clinical trial exploring the safety and efficacy of a high-strength formulation of RAYALDEE as a new treatment for SHPT in adult patients with stage 5 CKD requiring hemodialysis and vitamin D insufficiency. 

    Phase 4 Head-to-Head Study in Patients with Stage 3 or 4 CKD

    In this Phase 4 study, approximately 80 patients from multiple U.S. clinics will be treated for 2 months in a randomized, open-label fashion with RAYALDEE, high-dose cholecalciferol, immediate-release calcifediol, or a combination of paricalcitol and low-dose cholecalciferol.  To date, 67 subjects have been enrolled and 62 have completed treatment.  Enrollment is expected to be completed by the end of the second quarter of this year.

    The interim results from all subjects undergoing or completing treatment indicate that a daily dose of 60 mcg of RAYALDEE is the only one of the four treatment regimens tested that reliably raises serum total 25-hydroxyvitamin D to the range of 50 to 100 ng/mL, a level required to effectively suppress elevated plasma intact parathyroid hormone (iPTH) in CKD patients (Ennis et at 2016, Strugnell et al 2019).

    The mean iPTH reduction observed so far with RAYALDEE has exceeded 25% from pre-treatment baseline.  Cholecalciferol, at a dose of 300,000 international units (IU) per month, and immediate-release calcifediol, at a dose of 265 mcg/month as approved in Europe, have raised mean serum 25-hydroxyvitamin D levels to just over 30 ng/mL and reduced mean plasma iPTH by less than 10%.  The inability of cholecalciferol to raise serum 25-hydroxyvitamin D to the desired target range appears to be due to the higher body weights seen in CKD patients.  The combination of paricalcitol (1 mcg per day escalating to 2 mcg per day) and cholecalciferol (800 IU per day) has had no effect on serum 25-hydroxyvitamin D, but has lowered plasma iPTH to approximately the same extent as RAYALDEE.  Vitamin D receptor activators, such as paricalcitol, can effectively suppress iPTH without increasing serum 25-hydroxyvitamin D, but are no longer suggested for routine use in patients with stage 3 or 4 CKD according to the Kidney Disease Improving Global Outcomes (KDIGO) 2017 Clinical Practice Guideline Update for CKD-Mineral and Bone Disorder (CKD-MBD).

    Final results from the ongoing Phase 4 trial are expected in the second half of 2020.

    Phase 2 Trial in Patients with Stage 5 CKD on Dialysis

    This Phase 2 trial is being conducted in two successive cohorts, the first of which will involve up to approximately 44 patients from multiple U.S. dialysis centers treated in a randomized, open-label fashion with either RAYALDEE or placebo for 26 weeks.  The second cohort will involve approximately 300 patients in multiple countries treated in a randomized, double-blind fashion with one of three different doses of RAYALDEE or placebo for 26 weeks, followed by another 26 weeks in an open label extension.

    The goals of the first cohort are as follows: (1) to evaluate whether patients can tolerate the highest dose of RAYALDEE (900 mcg/week) to be used in the second cohort; (2) to verify that calcifediol, the active ingredient in RAYALDEE, can be activated in the absence of functional kidneys; and (3) to determine whether RAYALDEE is capable of treating SHPT in patients with end-stage renal disease.

    Interim results from 20 subjects who have completed at least 3 months of treatment indicate that all three goals are being met.  Specifically, RAYALDEE is (1) well tolerated (absence of significant changes in serum calcium and phosphorus or increased incidence of adverse events), (2) activated (serum levels of calcitriol, the active metabolite, are elevated) and (3) capable of treating SHPT (≥30% decreases in iPTH are observed from pre-treatment baseline).

    Full enrollment is expected in the second quarter of 2020, and final topline data are expected in the third quarter of 2020.

    "We are pleased to announce positive preliminary data from the ongoing Phase 4 comparative trial, which suggest that RAYALDEE may more effectively raise serum total 25-hydroxyvitamin D to the level required to effectively suppress elevated iPTH," commented Charles W. Bishop, PhD, Chief Executive Officer of OPKO's Renal Division.  "We are also pleased to announce positive proof-of-concept data from the ongoing Phase 2 trial.  These data are at odds with conventional wisdom that calcifediol is unlikely to be activated in patients who lack functional kidneys, and, while early, they indicate that RAYALDEE may be useful in treating SHPT in the growing global population of dialysis patients."

    About RAYALDEE

    RAYALDEE is an extended release formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.  The product is the only medicine approved by the U.S. Food and Drug Administration that raises serum total 25-hydroxyvitamin D and lowers blood levels of iPTH.  RAYALDEE, approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency, was launched in November 2016.  It is not yet approved for patients with stage 5 CKD on dialysis.

    About OPKO Health, Inc.

    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "could," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including product development efforts and the expected benefits of RAYALDEE, whether and when we will complete the clinical studies contemplated for RAYALDEE and whether final study data will be positive, our ability to develop and commercialize RAYALDEE, whether RAYALDEE is capable of treating SHPT in patients with end-stage renal disease, whether RAYALDEE will prove effective in treating patients with stage 5 CKD undergoing hemodialysis, whether RAYALDEE will be more effective than comparator products in raising serum total 25-hydroxyvitamin D to the range of 50 to 100 ng/mL and suppressing elevated plasma intact parathyroid hormone, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners for RAYALDEE, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    CONTACTS:
    Investors
    LHA Investor Relations
    Yvonne Briggs, 310-691-7100

    or
    Bruce Voss, 310-691-7100
     

    Primary Logo

    View Full Article Hide Full Article
  53. ELMWOOD PARK, N.J., March 24, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a collaboration with the City of Miami to provide coronavirus disease 2019 (COVID-19) testing. BioReference will provide COVID-19 testing at drive-through locations for Miami residents by appointment.

    BioReference is also announcing that they are providing testing for drive-through testing centers in South Florida, Hialeah and Hollywood through a collaboration with Larkin Community Hospital.

    "We all are responsible for helping to control the spread of this virus," said Francis Suarez, Mayor of the City of Miami. "As an individual who tested positive for COVID-19, I have a duty to the City of Miami to bring my city's residents access to testing and information, and through our partnership with BioReference, we can help address this public health crisis."

    "BioReference continues to prioritize expanding public access to COVID-19 testing across the nation," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The importance of high-quality, reliable, scalable laboratory tests available is a critical part of the response in the effort to contain COVID-19."

    If you demonstrate symptoms related with COVID-19, please call the Florida Department of Health immediately: 1-866-779-6121 or call the City of Miami COVID-19 Center: 1-305-960-5027.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.  

    About COVID-19 Testing at BioReference Laboratories, Inc.
    BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey and the City of Detroit to provide COVID-19 testing.

    BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-48 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 15,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com

    About OPKO Health
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 in Miami and the timing of and availability of the test, the turn-around time for testing and test capacity, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, reagent and supply shortages, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-and-city-of-miami-provide-testing-for-coronavirus-disease-2019-covid-19-301028664.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  54. ELMWOOD PARK, N.J., March 23, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a collaboration with the City of Detroit to provide coronavirus disease 2019 (COVID-19) testing. BioReference will provide COVID-19 testing at drive-through locations for Detroit residents by appointment.

    "The impact that expanded testing will have on residents of the City of Detroit is immeasurable," said Mike Duggan, Mayor of the City of Detroit. "Myself, and the residents of this great city are grateful for our relationship and partnership with BioReference." 

    "This is another example of BioReference assisting local governments around the country to provide COVID-19 testing," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "In addition to providing the residents of Detroit increased access to testing, there are first responders in the city who are waiting to get tested and we are privileged to support the exposed men and women on the front-lines in Detroit."

    The Detroit Medical Center (DMC) established a COVID-19 hotline for anyone with questions regarding the virus. DMC COVID-19 Hotline: 1-888-DMC-3370.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.  

    About COVID-19 Testing at BioReference Laboratories, Inc.
    BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals) and the State of New Jersey to provide COVID-19 testing.

    BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-48 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 15,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com

    About OPKO Health
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 in Detroit and the timing of and availability of the test, the turn-around time for testing and test capacity, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, reagent and supply shortages, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-and-city-of-detroit-provide-testing-for-coronavirus-disease-2019-covid-19-301027958.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  55. ELMWOOD PARK, N.J., March 20, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a collaboration with the State of New Jersey to provide coronavirus disease 2019 (COVID-19) testing across the State. BioReference will provide testing for the first NJ drive-through facilities in Burlington, Essex, Hudson, Ocean and Union Counties.

    "Expanded testing is imperative to protecting the people most susceptible to this epidemic, specifically senior citizens, people with chronic health problems, and those with compromised immune systems," said New Jersey Governor Phil Murphy. "We are grateful for this partnership with BioReference, as it means the people of New Jersey will have increased access to testing and faster results, helping limit the spread of COVID-19."

    "To support the high demand for convenient and efficient COVID-19 testing, BioReference and the State of New Jersey, the home of our main laboratory, have collaborated to expand access to testing across the State by providing an additional 10,000 tests to New Jersey residents," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "In addition, we are working with five counties directly in opening drive-through testing locations and will expand from there. It is a privilege to offer testing to residents of New Jersey, where the majority of our 4,000 employees live."

    The NJ Poison Control Center and 211 have partnered with the State of New Jersey to provide general information to the public on COVID-19: call 1-800-962-1253 or text: NJCOVID to 898-211 and include your zip code for live text assistance. Visit www.nj.gov/health for additional information.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.  

    About COVID-19 Testing at BioReference Laboratories, Inc.
    BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast, as well as a collaboration with the New York City Health and Hospital Corporation (NYC Health + Hospitals), the largest public healthcare system in the nation serving more than one million New Yorkers annually, to provide COVID-19 testing.

    BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-48 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 5,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.  

    About OPKO Health
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 in New Jersey and the timing of and availability of the test, the turn-around time for testing, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-and-state-of-new-jersey-provide-testing-for-coronavirus-disease-2019-covid-19-301027585.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  56. ELMWOOD PARK, N.J., March 17, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), today announced a collaboration with the New York City Health and Hospital Corporation (NYC Health + Hospitals) to provide coronavirus disease 2019 (COVID-19) testing. NYC Health + Hospitals is the largest public health care system in the nation serving more than a million New Yorkers annually in more than 70 patient care locations across the city's five boroughs.

    "This expanded testing for H+H is critical to protecting the New Yorkers most at risk in this epidemic, especially our seniors and people with chronic health problems," said New York City Mayor Bill de Blasio. "We are in a race against time, and we are trying to rapidly make up the ground lost by the federal government in the initial weeks of this crisis. The new partnership between H+H and BioReference means increased testing and faster results—helping save lives."

    "In support of the public health system as they provide healthcare to vulnerable and at-risk populations, BioReference is committed to prioritizing hospital patients suspected of COVID-19 infections and aid front-line physicians and healthcare providers to quickly and efficiently diagnose patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "In addition to the drive-through facilities, this collaboration is yet another example of how the private sector can assist with government agencies to help combat this epidemic."

    For more information about BioReference Laboratories and coronavirus testing options, please visit www.bioreference.com/coronavirus.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.  

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.  

    About OPKO Health
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 and the timing of and availability of the test,  as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/opko-healths-bioreference-laboratories-and-nyc-health--hospitals-enter-into-laboratory-collaboration-to-provide-testing-for-coronavirus-disease-2019-covid-19-301025710.html

    SOURCE BioReference Laboratories, Inc

    View Full Article Hide Full Article
  57. ELMWOOD PARK, N.J., March 13, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), is now accepting specimens for testing of coronavirus disease 2019 (COVID-19) from healthcare providers, clinics and health systems throughout the United States. In addition, BioReference has announced a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast. The facility will be located in New Rochelle, NY, the epicenter for the New York State outbreak. BioReference, in partnership with the state of New York, also expects to begin offering up to 5,000 tests a day at additional satellite testing sites to be set up next week. 

    ELMWOOD PARK, N.J., March 13, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), is now accepting specimens for testing of coronavirus disease 2019 (COVID-19) from healthcare providers, clinics and health systems throughout the United States. In addition, BioReference has announced a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast. The facility will be located in New Rochelle, NY, the epicenter for the New York State outbreak. BioReference, in partnership with the state of New York, also expects to begin offering up to 5,000 tests a day at additional satellite testing sites to be set up next week. 

    "Cases of COVID-19 are increasing across the US, making access to testing a critical component in helping healthcare providers identify infected patients more quickly. BioReference has been working expeditiously to develop and offer this test that will yield high-quality and accurate results," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "I believe that the private sector should be part of the solution in controlling the COVID-19 outbreak and am proud that BioReference can assist Governor Cuomo as he leads New York State through this crisis."

    For more information about BioReference Laboratories and coronavirus testing options, please visit www.bioreference.com/coronavirus.

    Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html 

    About BioReference Laboratories, Inc.
    BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit www.bioreference.com.  

    About OPKO Health 
    OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore® test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA.  In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed.  OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial.  It's among a new class of GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distributi