MNK

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Upcoming Catalysts

Drug Stage Catalyst Date
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
H.P. Acthar Gel
Amyotrophic Lateral Sclerosis
Phase 2
Phase 2
Phase 2 trial discontinued due to safety concerns - July 16, 2019.
Terlipressin
Hepatorenal syndrome (HRS) Type 1
CRL
CRL
CRL announced September 14, 2020.
MNK-6106
Hepatic Cirrhosis and Chronic Hepatic Encephalopathy (HE)
Phase 2a
Phase 2a
Phase 2 commencement of dosing announced August 12, 2019.
UVADEX (methoxsalen) and Therakos
Acute Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 enrolment to stop following interim analysis February 20, 2019.
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
Phase 3
Phase 3
Phase 3 data released May 7, 2019 did not meet primary endpoint.
MNK-812
Pain
CRL
CRL
CRL issued December 12, 2018.
VTS-270
Niemann-Pick Disease
Phase 3
Phase 3
Phase 3 trial did not show a statistically significant separation from placebo.
Stannsoporfin
Jaundice
CRL
CRL
CRL issued August 22, 2018.
RAPLIXA
Hemostasis
Approved
Approved
Approved April 30, 2015.

Latest News

  1. DUBLIN, Oct. 12, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK) ("Mallinckrodt" or the "Company") today announced that it has voluntarily initiated Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to modify its capital structure, including restructuring portions of its debt, and resolve several billion dollars of otherwise unmanageable potential legal liabilities. Mallinckrodt and all of its subsidiaries are continuing to operate and supply customers and patients with products as normal. 

    The entities that filed Chapter 11 petitions include Mallinckrodt plc, substantially all of its U.S. subsidiaries, including its specialty generics-focused subsidiaries (collectively, "Specialty Generics") and specialty brands-related subsidiaries (collectively, "Specialty Brands"), and certain of its international subsidiaries.

    The Company intends to use the Chapter 11 process to provide a fair, orderly, efficient and legally binding mechanism to implement a restructuring support agreement ("RSA") that, among other things, provides for an amended proposed opioid claims settlement and a financial restructuring that would:

    • Reduce the Company's total debt by approximately $1.3 billion, improving the Company's financial position and better positioning it for long-term growth;
    • Resolve opioid-related claims against the Company, its subsidiaries and related entities; and
    • Resolve various Acthar Gel-related matters, including the CMS Medicaid rebate dispute, an associated False Claims Act ("FCA") lawsuit and an FCA lawsuit relating to Acthar's previous owner's interactions with an independent charitable foundation.

    Taken together, these actions are intended to enable the Company to move forward with its vision to become an innovation-driven biopharmaceutical company meeting the needs of underserved patients with severe and critical conditions.

    Mark Trudeau, President and Chief Executive Officer of Mallinckrodt, said, "After many months of deliberation, negotiation and consideration of alternatives, Mallinckrodt's management and Board of Directors determined that implementing a Chapter 11 restructuring provides the best opportunity to maximize the value of the enterprise and position the Company for the future in light of the current challenges it faces. The actions we are taking are an important step forward for Mallinckrodt and our patients, employees, customers, suppliers and other partners. We have worked diligently over the last several months to evaluate all available options to achieve a comprehensive resolution to the significant litigation and debt issues overhanging our business. Having entered our restructuring support agreement and reached agreements in principle with a key group of opioid plaintiffs, other governmental parties and our guaranteed unsecured noteholders, we are beginning this process in a highly organized manner. We are now on a clear path to eliminating legal uncertainties, maximizing enterprise value, strengthening our balance sheet and moving ahead with our strategic plans. At the same time, we remain committed to improving health outcomes and developing and bringing to market therapies for patients with severe and critical conditions."

    Trudeau continued, "We are grateful to our employees for their continued commitment to our customers and the patients we serve. We also thank our suppliers and business partners for their support as we continue working together to improve the lives of patients." 

    Overview of Key RSA Terms 

    In connection with the Chapter 11 filing, the Company has entered into an RSA that provides for a financial restructuring designed to strengthen the Company's balance sheet and reduce its total debt by approximately $1.3 billion, improving the Company's financial position and allowing the Company to continue driving its strategic priorities and investing in the business to develop and commercialize therapies to improve health outcomes.

    Parties to the RSA include:

    • Holders of approximately 84% of the Company's guaranteed unsecured notes;
    • 50 states and territories; and
    • The court-appointed plaintiffs' executive committee representing the interests of thousands of plaintiffs in the opioid multidistrict litigation1 ("Opioid MDL"), which has agreed to recommend that the more than 1,000 counties, municipalities (including cities, towns and villages), Native American tribes and other opioid claimants in the Opioid MDL support the RSA.

    Under the terms of the RSA, at the end of the court-supervised process:

    • All allowed First Lien Credit Agreement Claims, First Lien Note Claims and Second Lien Note Claims are expected to be reinstated at existing rates and maturities;
    • Holders of allowed Guaranteed Unsecured Note Claims are expected to receive their pro rata share of $375 million of new secured second lien notes due seven years after emergence and 100% of New Mallinckrodt Ordinary Shares, subject to dilution by the warrants described below and certain other equity;
    • Trade creditors and holders of allowed General Unsecured Claims are expected to share in
    • $150 million in cash; and
    • Equity holders and non-guaranteed unsecured noteholders are expected to receive no recovery.

    Amended Proposed Opioid Settlement

    The Company has reached an agreement in principle on the terms of an amended proposed settlement that would resolve opioid-related claims against Mallinckrodt and its subsidiaries and eliminate billions of dollars in alleged liabilities. The amended proposed settlement is supported by a broad array of opioid plaintiffs as detailed above.

    Under the terms of the amended proposed settlement, which would become effective upon Mallinckrodt's emergence from the Chapter 11 process, subject to court approval and other conditions:

    • Opioid claims would be channeled to one or more trusts, which would receive $1.6 billion in structured payments.
      • $450 million would be received upon the Company's emergence from Chapter 11;
      • $200 million would be received on each of the first and second anniversaries of emergence; and
      • $150 million would be received on each of the third through seventh anniversaries of emergence with a one-year prepayment option at a discount for all but the first payment.
    • Opioid claimants would also receive warrants for approximately 19.99% of the Company's fully diluted outstanding shares, including after giving effect to the exercise of the warrants, exercisable at a strike price reflecting an aggregate equity value of $1.551 billion.
    • Upon commencing the Chapter 11 filing, the Company will comply with an agreed-upon operating injunction with respect to the operation of its opioid business.

    Copies of term sheets outlining the terms of the RSA and the amended opioid settlement, as well as materials with additional information relating to the Company and its Chapter 11 filing, are available on www.advancingmnk.com. The term sheets and additional materials are expected be filed as an exhibit to a Current Report on Form 8-K with the U.S. Securities and Exchange Commission tomorrow.

    Resolution of Certain Acthar Gel-Related Matters

    Mallinckrodt has reached an agreement in principle with certain governmental parties to resolve certain disputes relating to Acthar Gel. The agreement in principle is conditioned upon Mallinckrodt entering the Chapter 11 restructuring process. The Company has agreed to pay $260 million over seven years and reset Acthar Gel's Medicaid rebate calculation as of July 1, 2020, such that state Medicaid programs will receive 100% rebates on Acthar Gel Medicaid sales, based on current Acthar Gel pricing. Additionally, upon execution of the settlement, the Company will dismiss its appeal of the CMS Medicaid rebate ruling currently pending in the U.S. Court of Appeals for the D.C. Circuit. The settlement would resolve the CMS Medicaid rebate dispute, the associated FCA lawsuit in Boston and an FCA lawsuit in the Eastern District of Pennsylvania relating to Acthar's previous owner's interactions with an independent charitable foundation.

    Mallinckrodt expects to complete the settlement over the next several months, subject to Bankruptcy Court approval.

    Continuing to Serve Patients and Customers as Normal

    The current consolidated cash balance of the Chapter 11 filing entities is more than $650 million. Together with cash generated from ongoing operations, this is expected to provide ample liquidity to support continued operations during the court-supervised process.

    The Company has filed a number of customary motions seeking court authorization to continue to support its business operations during the court-supervised process, including the continued payment of employee wages and benefits without interruption. The Company intends to pay vendors and suppliers in full under normal terms for goods received and services rendered on or after the filing date. The Company expects to receive court approval for all of these routine requests. The Company's foreign non-debtor affiliates will continue to operate their businesses in the ordinary course.

    Separating the Specialty Generics and Specialty Brands businesses remains one of Mallinckrodt's goals. The Company will continue to evaluate strategic options for the Specialty Generics business at an appropriate time and when market conditions are favorable.

    Additional Information

    Additional information about the court-supervised process is available at www.advancingmnk.com. Court filings and other information related to the court-supervised process are available on a separate website administered by the Company's claims agent, Prime Clerk, at http://restructuring.primeclerk.com/Mallinckrodt; by calling Prime Clerk representatives toll-free in the U.S. and Canada at 877-467-1570 or 347-817-4093 for international calls; or by emailing Prime Clerk at .  

    For supplier-related inquiries, please call the Company toll-free in the U.S. at +1-833-954-2209 or +1-314-654-3008 for international calls, or email the Company at .  

    Advisors

    Latham & Watkins LLP, Ropes & Gray LLP and Wachtell, Lipton, Rosen & Katz are serving as counsel, Guggenheim Securities, LLC is serving as investment banker and AlixPartners LLP is serving as restructuring advisor to Mallinckrodt. Hogan Lovells is serving as counsel with respect to the Acthar Gel matter.

    About Mallinckrodt

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    Statements in this document that are not strictly historical, including statements regarding future financial condition and operating results, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments the company believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.

    There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the proposed settlement with governmental parties to resolve certain disputes relating to Acthar Gel; the possibility that such settlement will not be consummated and the risks and uncertainties related thereto, including the time and expense of continuing to litigate this dispute and the impact of this dispute on Mallinckrodt's financial condition and expectations for performance; the impact of the outbreak of the COVID-19 coronavirus; the bankruptcy process, the ability of Mallinckrodt and its subsidiaries to obtain approval from the bankruptcy court with respect to motions or other requests made to the bankruptcy court throughout the course of the Chapter 11 cases and to negotiate, develop, obtain court approval of, confirm and consummate the plan of reorganization contemplated by the restructuring support agreement or any other plan that may be proposed, the effects of the Chapter 11 cases, including increased professional costs, on the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; the consummation of the transactions contemplated by the restructuring support agreement, including the ability of the parties to negotiate definitive agreements with respect to the matters covered by the term sheets included in the restructuring support agreement, the occurrence of events that may give rise to a right of any of the parties to terminate the restructuring support agreement and the ability of the parties to receive the required approval by the bankruptcy court and to satisfy the other conditions of the restructuring support agreement; governmental investigations and inquiries, regulatory actions and lawsuits brought against Mallinckrodt by government agencies and private parties with respect to its historical commercialization of opioids, including the amended non-binding agreement in principle reached by Mallinckrodt in connection with the announcement of its filing of the Chapter 11 petitions regarding the terms and conditions of a global settlement to resolve all current and future opioid-related claims; Mallinckrodt's ability to comply with the continued listing criteria of the New York Stock Exchange (the "NYSE") and risks arising from the potential suspension of trading of Mallinckrodt's ordinary shares on, or delisting from, the NYSE and the effects of Chapter 11 on the interests of various constituents; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; Mallinckrodt's and its partners' ability to successfully develop or commercialize new products or expand commercial opportunities; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; potential indemnification liabilities to Covidien pursuant to the separation and distribution agreement; business development activities; retention of key personnel; the effectiveness of information technology infrastructure including cybersecurity and data leakage risks; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; labor and employment laws and regulations; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness and its ability to generate sufficient cash to reduce its indebtedness; future changes to U.S. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

    These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2019 and Form 10-Q for the fiscal quarter ended June 26, 2020. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACTS

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Media

    Michael Freitag / Aaron Palash / Aura Reinhard

    Joele Frank, Wilkinson Brimmer Katcher

    212-355-4449

    Government Affairs

    Mark Tyndall

    Senior Vice President, Government Affairs

    & Chief Counsel, Litigation

    202-459-4141

    1Captioned In re National Prescription Opiate Litigation, Case No. 17-md-2804 (N.D. Ohio).

    2Mallinckrodt, the "M" brand mark and the Mallinckrodt pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2020 10/20.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-secures-broad-consensus-with-key-stakeholders-on-comprehensive-chapter-11-restructuring-301149931.html

    SOURCE Mallinckrodt plc

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  2. DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

    The CRL stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1. HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis1 for which there is currently no FDA-approved treatment.2 HRS-1 is estimated to affect between 30,000 and 40,000 Americans annually,3,4 and often is a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion.5 If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.5,6 U.S. discharge data in a recently published study indicated an in-hospital mortality rate of 34.2% (n=1,133), while an additional 14.4% (n=475) of patients were discharged to hospice.7

    "While we are disappointed that the FDA issued a complete response letter for terlipressin, we remain confident in the strength of the data from our Phase 3 CONFIRM study, which is the largest clinical trial ever conducted in this rare condition," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "HRS-1 is a complex disease that affects a critically ill patient population with no approved treatment in the U.S. at present. We are surprised by and disagree with the FDA's decision and remain committed to pursuing all available options as we continue working with the FDA toward approval of terlipressin in order to help address this difficult and life-threatening syndrome."

    Terlipressin is an investigational agent being evaluated for the treatment of HRS-1 in the U.S., and its safety and effectiveness have not yet been established by the FDA.

    Terlipressin is approved in many countries outside the United States, where it has been a standard of care for decades in the treatment of patients with HRS-1.8,9 Terlipressin, together with albumin, is currently the standard of care for HRS-1 in countries where it is available.10

    In 2005, terlipressin was granted Fast Track designation by the FDA, which provides for expedited review to facilitate development of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need.11 In 2016, Mallinckrodt and the FDA reached agreement on the Phase 3 CONFIRM trial protocol design and data analysis under the agency's special protocol assessment (SPA) process. A SPA is an advance agreement with the FDA for the acceptability of the clinical design, endpoints and statistical data analyses for a Phase 3 trial before the start of the trial.

    On July 15, 2020, the company announced that the Cardiovascular and Renal Drugs Advisory Committee of the FDA voted to recommend approval of its investigational agent terlipressin to treat adults with HRS-1 based, in part, on results from the Phase 3 CONFIRM trial. The CONFIRM trial was the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of terlipressin in patients with HRS-1 for potential use in the U.S. and Canada. Initial results were presented in a late-breaking session at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

    About Terlipressin

    Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and Canada.

    ABOUT MALLINCKRODT 

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    This release includes forward-looking statements with regard to terlipressin, including with regard to interactions with regulators as well as its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACT

    Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2020 Mallinckrodt. US-2001369 09/20

    References

    1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed September 12, 2020.

    2 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials. 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT

    3 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. Journal of Investigative Medicine. 2016; 64:33–38.

    4 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed September 12, 2020.

    5 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018;4:23. 

    6 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Review of Gastroenterology & Hepatology. 2018;12(2):173-188. DOI: 10.1080/17474124.2018.1417034. 

    7 Jamil K, Lodaya K, Tavares R, Huang X, Hayashida D. The hepatorenal syndrome patient journey: Portrait of an often-fatal path for those with liver disease. Presented at Digestive Disease Week® (DDW) Chicago, IL. May 2, 2020May 5, 2020.

    8 De Franchis R. Evolving Consensus in Portal Hypertension Report of the Baveno IV Consensus Workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2005;43:167-176.

    9 Ioannou GN, Doust J, Rockey DC. Terlipressin for acute esophageal variceal hemorrhage. Cochrane Database of Systematic Reviews. 2003;1. doi: 10.1002/14651858.CD002147.

    10 European Association for the Study of the Liver (EASL). Clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69(2):406-460.

    11 U.S. Food and Drug Administration (FDA). Fast Track. Available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. Accessed September 12, 2020.  

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-receives-a-complete-response-letter-from-the-us-food-and-drug-administration-fda-for-terlipressin-for-the-treatment-of-hepatorenal-syndrome-type-1-hrs-1-301129813.html

    SOURCE Mallinckrodt Pharmaceuticals

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  3. New York, United States, Fri, 28 Aug 2020 03:29:23 / Comserve Inc. / -- The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028.

    Research Nester released a report titled "Amphetamine Drug Market – Global Demand Analysis & Opportunity Outlook 2028" which delivers a detailed overview of the amphetamine drug market in terms of market segmentation by application, by demography, by distribution channel, and by region.

    Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis, and Porter's five force model.

    The amphetamine drug market is segmented by application, by demography, by distribution…

    New York, United States, Fri, 28 Aug 2020 03:29:23 / Comserve Inc. / -- The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028.

    Research Nester released a report titled "Amphetamine Drug Market – Global Demand Analysis & Opportunity Outlook 2028" which delivers a detailed overview of the amphetamine drug market in terms of market segmentation by application, by demography, by distribution channel, and by region.

    Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis, and Porter's five force model.

    The amphetamine drug market is segmented by application, by demography, by distribution channel, and by region. Based on the application, the amphetamine drug market is segmented into ADHD, narcolepsy, obesity, depression, and others, out of which the depression segment is anticipated to dominate the market owing to the increase in the prevalence of depression among adults and children around the world. On the basis of demographics, the amphetamine drug market has been bifurcated into children and adults. Among the demographic segment, the adult is anticipated to hold the largest share in the market attributed to a large adult patient population. The amphetamine drug market is anticipated to record a robust CAGR during the forecast period, i.e. 2020-2028. This market is thriving on the back of a rising number of ADHD patients and governments' approvals and initiatives to address the health related problems. Along with this, the investments into healthcare system for the betterment of the society further are anticipated to raise the market growth. According to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), in 2015, there were 17.2 million individuals who used stimulants, of which 1.8 million were youth and 4.9 million were adults.Request Here For Sample Copy

    "The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

    Based on the regional analysis, the amphetamine drug market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. The market in North America region is anticipated to dominate the global market and accounted for rising prevalence in the number of depression and ADHD patients globally. Additionally, the continuous focus of key market players is on the consumers, encouraging them to innovate in the market. Such factors are anticipated to boost the market growth of the region. The market in Europe is anticipated to hold the second-largest share owing to the presence of massive pharmaceutical firms in the region

    The increasing number of ADHD patients worldwide

    According to the survey done by the Centers for Disease Control and Prevention (CDC), 2016, 0.388 million children aged 2–5 years, 4 million children aged 6–11 years, and 3 million children aged 12–17 years, were diagnosed with ADHD in the U.S.

    The global surge in the number of incidences is associated with ADHD due to the dearth of established treatment for this disorder. People are left with long-running medication procedures for their treatment. The medicinal treatment through CNS stimulants such as amphetamine is the most preferred way to treat the patient. This is expected to incite the growth of the global amphetamine drug market. However, the side-effects and contraindications related to amphetamine drugs are some of the factors that are estimated to limit market growth. Download a PDF copy of this report:

    "The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

    This report also provides the existing competitive scenario of some of the key players of the amphetamine drug market which includes company profiling of Teva Pharmaceutical Industries Ltd. (TLV: TEVA), Pfizer Inc. (NYSE:PFE), Novartis AG (SWX: NOVN), Eli Lilly and Company (NYSE:LLY), GlaxoSmithKline plc (LON: GSK), Mallinckrodt Company (NYSE:MNK), Johnson & Johnson Services, Inc. (NYSE:JNJ), Hisamitsu Pharmaceutical Co., Inc. (TYO:4530), and Purdue Pharma L.P. The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials, and recent news and developments. On the whole, the report depicts a detailed overview of the amphetamine drug market that will help industry consultants, manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market-centric strategies accordingly to the ongoing and expected trends in the future.

    Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

    For more information, please contact:

    AJ Daniel

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  4. ST. LOUIS, Aug. 24, 2020 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE:MNK), a global biopharmaceutical company, today announced that its Specialty Generics business has been recognized as a Manufacturing Leadership Award winner for outstanding achievement by the National Association of Manufacturers (NAM).

    The Specialty Generics business' Hobart, N.Y. manufacturing site received awards for outstanding achievement in two categories – Operational Excellence Leadership and Engineering and Production Technology Leadership.

    Spiro Gavaris, President, Mallinckrodt Specialty Generics said, "We are extremely proud to receive the National Association of Manufacturers' prestigious manufacturing leadership awards for the third consecutive year. This recognition further demonstrates Mallinckrodt's history of innovative manufacturing solutions, our focus on being the US-based supplier of choice for specialty generic drugs and active pharmaceutical ingredients, and our commitment to providing patients access to quality medicines."

    This year, Mallinckrodt's Hobart, N.Y. manufacturing site was recognized in the Operational Excellence Leadership category for its Packaging Changeover Improvement Project that successfully reduced the changeover time of packaging lines by 50% and decreased the variability of time to completion.

    The Hobart site's Packaging Serialization Project was an award winner in the Engineering & Production Technology Leadership category for its achievement in upgrading the facility's packaging lines, which enabled production of fully serialized pharmaceutical finished product with full pallet aggregation two years ahead of FDA requirements.

    "We are very pleased that NAM's Leadership Council has recognized our Hobart site for manufacturing leadership in operational excellence, as well as engineering and production technology," said David Hollingshead, Senior Director of Manufacturing. "Achieving six awards in the last three years is testimony to our employees' dedication to the strategy development and deployment process in becoming a premier manufacturing site. Continuous improvement is core in the mindsets and behaviors of our most important asset – our people."

    Mallinckrodt will be recognized at the 16th Annual Manufacturing Leadership Awards Gala which will be held virtually on October 8, 2020.

    About Mallinckrodt 

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    About the Manufacturing Leadership Awards

    The Manufacturing Leadership Awards honor manufacturing companies and individual manufacturing leaders that are shaping the future of global manufacturing. Winning projects and individual manufacturing leaders have demonstrated achievement in one of a wide range of categories, and are chosen by a panel of expert judges for results that have delivered clear and compelling value, return on investment, and other tangible outcomes. For more information on the Manufacturing Leadership Awards Gala or Rethink: The Manufacturing Leadership Council Summit, please go to www.MLCRethink.com.

    About the National Association of Manufacturers

    The National Association of Manufacturers (NAM) is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states.

    The NAM's world-class staff of policy experts provide unmatched access and information on the key issues affecting your business and bottom line. It is on the front lines of a wide range of policy battles, from immigration reform and labor relations, to energy and the environment, to trade policy and taxes.

    www.nam.org 

    CONTACTS

    For Financial/Dailies Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813-545-2399

     

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and IRO

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2020 Mallinckrodt. US-2000671 08/20

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    SOURCE Mallinckrodt Pharmaceuticals

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  5. STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021.

    Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.

    "Treatment advances are needed that can help minimize or eliminate the need for autografting. The FDA's acceptance of the BLA submission for StrataGraft skin tissue for review takes us one step closer to providing adult burn patients in the United States with a potential new treatment option for deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering solutions to patients with severe and critical conditions, and look forward to working with the FDA during the regulatory review process for StrataGraft skin tissue."

    The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016 clinical trial, previously published as an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in Burns. Top-line results from the Phase 3 trial of StrataGraft skin tissue, which met both primary endpoints in adults with deep partial-thickness thermal burns, including autograft sparing and durable wound closure, were announced in September 2019.

    The completion of the BLA rolling submission was announced on June 9, 2020. The FDA granted StrataGraft skin tissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

    About StrataGraft

    StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

    Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations. 

    StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    The continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the BLA process for StrataGraft skin tissue in the United States, is being supported through a partnership with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

    About Deep Partial-Thickness Thermal Burns

    Deep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

    Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

    About Mallinckrodt

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    Cautionary Statements Related to Forward-Looking Statements

    This release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including the anticipated regulatory review process, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACTS

    For Trade Media Inquiries

    Sheryl Seapy

    W2O

    213-262-9390

    For Financial/Dailies Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813 545 2399

      

    Investor Relations

    Daniel J. Speciale

    Vice President, Investor Relations and IRO

    314-654-3638

    Government Affairs

    Mark Tyndall

    Senior Vice President, Government Affairs & Chief Counsel, Litigation

    202-459-4141

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

    ©2020 Mallinckrodt. US-2001226 07/20.

    ________________________

    1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.

    2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

     

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    SOURCE Mallinckrodt plc

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