TAK Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)

18.49
-0.06  -0%
Previous Close 18.55
Open 18.53
52 Week Low 12.43
52 Week High 20.925
Market Cap $57,803,498,092
Shares 3,126,203,250
Float 3,126,203,250
Enterprise Value $100,363,578,316
Volume 498,014
Av. Daily Volume 1,105,776
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Cabozantinib - COSMIC-311
Thyroid Carcinoma
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
TAK-609
Hunter Syndrome
NDA Filing
NDA Filing
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Cabozantinib
Medullary Thyroid Cancer
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
CB-839 + Cabozantinib (CANTATA)
Renal cell carcinoma
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Pevonedistat (TAK-924)
Higher-risk myelodysplastic syndromes (HR-MDS)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Cabozantinib and Nivolumab and Ipilimumab (COSMIC-313)
Renal Cell Carcinoma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
CoVIg-19
COVID-19
Phase 1
Phase 1
Registration-enabling trial to commence in the coming weeks - noted July 31, 2020.
TAK-831
Negative symptoms of schizophrenia
Phase 2
Phase 2
Phase 2 trial is ongoing.
Ponatinib (OPTIC)
Chronic Myeloid Leukemia
Phase 2
Phase 2
Phase 2 data presented at EHA June 2020.
TAK-041
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned.
TAK-653
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial planned.
ALUNBRIG (brigatinib)
ALK+ Metastatic Non-Small Cell Lung Cancer
Approved
Approved
FDA Approval announced May 22, 2020.
Ixazomib - TOURMALINE-MM4
Multiple myeloma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 8, 2019.
Vedolizumab
Crohn's Disease
Phase 3
Phase 3
Phase 3 trial met primary endpoint - July 22, 2020.
Entyvio
Ulcerative Colitis
CRL
CRL
CRL issued December 21, 2020.
NINLARO (ixazomib) lenalidomide and dexamethasone - TOURMALINE-MM2
Multiple myeloma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 10, 2020.
Cabozantinib
Medullary thyroid cancer
Approved
Approved
Approved November 29, 2012.
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Approved
Approved
FDA Approval announced January 14, 2019.
CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER
First-line renal cell carcinoma
Phase 3
Phase 3
Phase 3 trial met PFS and OS endpoints - April 20, 2020.
ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approved
Approval announced August 19, 2011.
ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved
Approved August 17, 2015 under priority review.
ADCETRIS in combination with chemotherapy - ECHELON-2
Frontline CD30-positive mature T-cell lymphomas - cancer
Approved
Approved
FDA Approval announced November 16, 2018.
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Approved
Approved
sBLA approval announced March 20, 2018. PDUFA date under priority review was May 1, 2018.
ALUNBRIG versus alectinib ALTA 3
ALK+ Advanced NSCLC
Phase 3
Phase 3
Phase 3 trial is enrolling.
Mobocertinib (TAK-788)
Non-Small Cell Lung Cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial has completed enrolment.
Mobocertinib (TAK-788) - EXCLAIM
non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 trial has completed enrolment.
Mobocertinib EXCLAIM-2
NSCLC with EGFR exon 20 insertion mutations
Phase 3
Phase 3
Phase 3 trial is enrolling.

Latest News

  1. A series of public service announcements, which feature award-winning actress, writer, and bleeding disorder advocate Alex Borstein, will elevate the understanding and awareness of von Willebrand disease – the most common hereditary bleeding disorder, affecting up to 1% of Americans1

    Up to one in every 100 Americans is affected by von Willebrand disease1 (VWD) – but how many have heard of this condition? A new series of public service announcements, featuring actress Alex Borstein, aims to educate the public about the symptoms of this inherited bleeding disorder and encourages those who think they may be affected to talk with their healthcare professional. The Public Service Announcement (PSA) series, launched during the National Hemophilia…

    A series of public service announcements, which feature award-winning actress, writer, and bleeding disorder advocate Alex Borstein, will elevate the understanding and awareness of von Willebrand disease – the most common hereditary bleeding disorder, affecting up to 1% of Americans1

    Up to one in every 100 Americans is affected by von Willebrand disease1 (VWD) – but how many have heard of this condition? A new series of public service announcements, featuring actress Alex Borstein, aims to educate the public about the symptoms of this inherited bleeding disorder and encourages those who think they may be affected to talk with their healthcare professional. The Public Service Announcement (PSA) series, launched during the National Hemophilia Foundation's (NHF) Virtual Bleeding Disorders Conference (August 1-8, 2020), was produced by Takeda ((TAK) in partnership with the NHF, and will be running nationwide for the next six months.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200810005030/en/

    Alex Borstein — star of the hit series The Marvelous Mrs. Maisel — has first hand experience caring for those with bleeding disorders. Her brother and uncle live with hemophilia A, her daughter has mild hemophilia, and Alex herself is a carrier of the disease. Knowing just how devastating an inherited bleeding disorder can be, Alex has taken it upon herself to find ways to support the bleeding disorder community and offer encouragement and advocacy where she can as a spokesperson for the NHF. She is particularly excited to personally participate in the launch of the PSA series in tandem with this year's annual NHF conference.

    "Taking an active role in the bleeding disorder community isn't a choice for me; it's a responsibility," said Borstein. "Von Willebrand disease affects millions of Americans but is often overlooked, even by some healthcare professionals. I am here to encourage others to advocate for themselves, their families and their loved ones - if they suspect they may have a bleeding disorder, speak up and ask their doctor to be tested."

    People living with VWD lack proper quantities or quality of a clotting protein in the blood called von Willebrand factor, and they may or may not have a secondary factor VIII (FVIII) deficiency.1,2 They can experience frequent nosebleeds, easy bruising, heavy/long menstrual bleeding and excessive bleeding during and after invasive procedures, such as tooth extractions and other surgeries.1 To be diagnosed, the NHF recommends visiting a hemophilia treatment center (HTC).3 There, a hematologist will perform various tests to evaluate clotting capability, platelet function and factor protein levels.3 If you are diagnosed with VWD, work closely with your healthcare team to establish a management plan that works for you and allows you to manage your condition.3

    "While von Willebrand disease can cause serious health issues for patients, it can be managed if properly and promptly diagnosed. Unfortunately, diagnosis is where we're seeing the biggest disconnect," said Dr. Leonard Valentino, President and Chief Executive Officer of NHF. "We're so grateful that Alex is willing to share her time and platform to help raise awareness of this disease and encourage those who think they may have a bleeding disorder to talk to their doctor about getting tested."

    "Takeda is proud to partner with NHF to help raise awareness around VWD. There's a saying: ‘You can't be what you can't see.' It is through the courage of advocates like Alex Borstein coming forward and sharing their stories, that others who may be experiencing similar issues feel empowered to take their health concerns into their own hands and proactively talk with their healthcare team about a possible diagnosis and appropriate treatment plan," said Joanna Stevens, Vice President and US Hematology Franchise Head at Takeda. "It is critically important for patients and their caregivers to educate themselves about bleeding disorders, such as VWD, so that they feel prepared to ask questions and work with their healthcare team to develop a treatment plan that works for them."

    Following the launch of the PSA campaign on August 7, 2020, additional education and resources will be available on ThinkVWD.com.

    About von Willebrand disease (VWD)

    VWD is the most common inherited bleeding disorder, affecting up to one percent of the U.S. population.1 VWD is caused by a deficiency or dysfunction of von Willebrand factor (VWF), one of several types of proteins in the blood that are needed to facilitate proper blood clotting.1 Due to this defect or deficiency in VWF, blood is not able to clot effectively in people with VWD, which may result in heavy menstrual periods, easy bruising or frequent nose bleeds.1 Bleeding caused by VWD varies greatly among patients with this disease.4

    About National Hemophilia Foundation

    The National Hemophilia Foundation (NHF) is dedicated to finding better treatments and cures for inheritable bleeding disorders and to preventing the complications of these disorders through education, advocacy and research. Established in 1948, the National Hemophilia Foundation has chapters throughout the country. Its programs and initiatives are made possible through the generosity of individuals, corporations and foundations as well as through a cooperative agreement with the Centers for Disease Control and Prevention (CDC).

    About Takeda Hematology

    Takeda is a leader in hemophilia with the longest heritage and a market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years of experience driving innovation for patients and a broad portfolio of 11 products across multiple bleeding disorders. Our experience as leaders in hematology means we are well prepared to meet today's needs as we pursue future developments in the treatment of bleeding disorders. Together with the hematology community, we are committed to raising expectations for the future, including earlier diagnosis, earlier and better protection against bleeds, and more personalized patient care.

    About Takeda Pharmaceutical Company

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit http://www.hemophilia.org or https://www.takeda.com.

    References

    1. National Hemophilia Foundation. "Von Willebrand Disease." National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Von-Willebrand-Disease. Last accessed January 2020.
    2. Favaloro E. "Towards personalised therapy for von Willebrand disease: a future role for recombinant products." Blood Transfusion. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4918558/. Last accessed January 2020.
    3. National Hemophilia Foundation. 2014. Introduction to von Willebrand Disease [Brochure]. Retrieved from https://www.hemophilia.org/sites/default/files/basic-page/documents/Introduction-to-von-Willibrand-Disease-Brochure-2014.pdf. Last accessed January 2020.
    4. National Hemophilia Foundation. "VWD Summit Highlights." HEMAWARE website. https://hemaware.org/story/vwd-summit-highights. Last accessed January 2020.
    5. Takeda. "Rare Diseases." Takeda Website. https://www.takeda.com/what-we-do/areas-of-focus/rare-diseases/. Last accessed January 2020.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takeda's estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s), any of which may cause Takeda's actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda's results, performance, achievements, or financial position, see "Item 3. Key Information—D. Risk Factors" in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda's future results.

    View Full Article Hide Full Article
    • Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan
    • Matrix-M adjuvant to be supplied from Novavax
    • Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing
    • Adds to Takeda's ongoing support of influenza pandemic preparedness in Japan

    GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax' COVID‑19 vaccine…

    • Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan

    • Matrix-M adjuvant to be supplied from Novavax
    • Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing
    • Adds to Takeda's ongoing support of influenza pandemic preparedness in Japan

    GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan's Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1.

    "Takeda's leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX‑CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan."

    Novavax and Takeda are partnering on manufacturing, clinical development and regulatory activities in Japan. Novavax will license and transfer manufacturing technologies to enable Takeda to manufacture the vaccine antigen and will supply the Matrix-M adjuvant to Takeda. Takeda will be responsible for regulatory submission to the MHLW and will produce and distribute NVX‑CoV2373 in Japan.

    "Nothing is more important right now than protecting the world against COVID-19. We are excited to collaborate with Novavax to bring their promising vaccine candidate to Japan," said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. "Today's announcement builds upon our ongoing support of pandemic preparedness and demonstrates Takeda's commitment to the health and well-being of the Japanese population."

    Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Takeda's Commitment to Vaccines

    Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, Zika and norovirus. Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs. For more information, visit www.TakedaVaccines.com.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the rights and responsibilities of each of Novavax and Takeda in their partnership, plans related to manufacturing [(including vaccine antigen dose amounts)], development, regulatory and commercial activities in Japan, potential payments to Novavax from Takeda, Novavax' expectations of third-party funding and anticipated timing of Novavax' clinical trial results are forward-looking statements. These statements may be identified by words such as "expect," "look forward," "potential," "will" and similar references to future periods. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include uncertainty of success in the development and potential commercialization of NVX-CoV2373, unexpected delays in clinical trials or regulatory review of NVX-CoV2373, potential set backs in scaling up manufacturing of NVX-CoV2373, adverse impacts of the ongoing COVID-19 pandemic on Novavax' business, Novavax' future capital requirements and availability of funding, as well as those risks identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC), and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.

    Takeda Pharmaceutical Company Limited Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Takeda Pharmaceuticals

    Media in Japan

    Kazumi Kobayashi

    +81 (0) 3-3278-2095





    Media Outside Japan

    Amy Atwood

    +1 774-571-3316




    1.     The projected capacity is an estimate only based on current assumptions from Novavax.

    Primary Logo

    View Full Article Hide Full Article
  2. New center in Baton Rouge opens to support an urgent patient need for human plasma

    BioLife Plasma Services, part of the global biopharmaceutical company Takeda Pharmaceutical Company Limited, today announced the opening of a new plasma collection center in Baton Rouge to collect standard plasma from healthy donors.

    "Now, more than ever, donors in the Baton Rouge area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications," said Jason Kilpatrick, manager of the BioLife Plasma Services Baton Rouge center. "Plasma is a lifeline for thousands of people with rare, chronic and complex diseases…

    New center in Baton Rouge opens to support an urgent patient need for human plasma

    BioLife Plasma Services, part of the global biopharmaceutical company Takeda Pharmaceutical Company Limited, today announced the opening of a new plasma collection center in Baton Rouge to collect standard plasma from healthy donors.

    "Now, more than ever, donors in the Baton Rouge area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications," said Jason Kilpatrick, manager of the BioLife Plasma Services Baton Rouge center. "Plasma is a lifeline for thousands of people with rare, chronic and complex diseases, and we are excited to open the first BioLife plasma collection center in Louisiana."

    Through a simple, low-risk process called plasmapheresis, plasma is separated from the blood and the blood elements are returned back into the donor's body. Screened plasma collected from healthy individuals is processed into a wide variety of therapeutics for people around the world with rare, life-threatening diseases, such as immunodeficiency disorders, hemophilia and hereditary angioedema.

    Due to the COVID-19 pandemic, BioLife Plasma Services has implemented additional screening and safety measures in line with public health guidance to help guarantee the safety and health of donors and employees, as well as the safety of the collected plasma. All donors will need to wear a mask or other cloth face covering inside a BioLife Plasma center.

    Prospective donors can make online appointments to visit the Baton Rouge center (11620 Coursey Blvd., Baton Rouge, LA 70816), which opens on Saturday, August 8. They must pass a physical examination at their first visit and are screened at each visit to ensure they meet eligibility criteria. All donors are compensated for their time and commitment.

    The Baton Rouge center is approximately 14,000 square feet, and the state-of-the-art facility provides access to free Wi-Fi and a clean, professional, smoke-free environment. The new center is the first BioLife center to open in Louisiana and expects to bring more than 60 new jobs to the community.

    To learn more about BioLife Plasma Services, the donation process, and to schedule an appointment, please visit the BioLife website.

    About Plasma

    Plasma is the clear, straw-colored liquid portion of blood that can be easily replaced by the body. Plasma makes up more than half of whole blood and consists primarily of water and proteins. During plasma donation, a donor's blood is collected into an automated device that separates the plasma from the other whole blood components, including red and white blood cells and platelets. While the plasma is collected, the other blood components are returned to the donor. Each donation procedure uses sterile and disposable collection materials. The body quickly replaces the plasma removed during the donation process, which allows healthy individuals to donate as often as twice in a seven-day period, with at least one day between donations.

    About BioLife Plasma Services

    BioLife Plasma Services is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies. Founded in 2002, BioLife has been in operation for 18 years. We operate approximately 150 state-of-the-art plasma collection facilities across the United States and Europe. BioLife Plasma Services is part of Takeda Pharmaceutical Company Limited (NYSE:TAK), a global values-based, R&D-driven pharmaceutical company that produces and delivers plasma-derived therapies among other specialty medicines.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

    View Full Article Hide Full Article
  3. SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Today, members of the COVID R&D Alliance AbbVie, Inc. (NYSE:ABBV), Amgen Inc. (NASDAQ:AMGN), and Takeda Pharmaceutical Co. Ltd. (NYSE:TAK) announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.

    SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Today, members of the COVID R&D Alliance AbbVie, Inc. (NYSE:ABBV), Amgen Inc. (NASDAQ:AMGN), and Takeda Pharmaceutical Co. Ltd. (NYSE:TAK) announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.

    The I-SPY COVID Trial utilizes Quantum Leap Healthcare Collaborative's adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.

    "Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19," said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation."

    The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. Food and Drug Administration (FDA). AbbVie, Amgen, and Takeda are members of the COVID R&D Alliance (COVID R&D), a group of more than 20 of the world's leading biopharmaceutical and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.

    "Sick patients in hospitals cannot wait; options are urgently needed. I'm proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID," remarked Andy Plump, President of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. "The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that upon investigation, may show efficacy in this devastating disease."

    The therapies under investigation were selected based on their potential to impact the immune system response of COVID-19 patients who need respiratory support. Approximately 10-15 percent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 percent of those patients admitted to an ICU require ventilation for an average of two weeks. It is estimated that half of those patients will not survive. Based on the respective mechanisms of action, Otezla® may suppress inflammation resulting from an immune response, Firazyr® may ameliorate bradykinin-driven pulmonary edema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of ARDS response in severely ill COVID-19 patients.

    Dr. Laura Esserman, co-founder of Quantum Leap Healthcare Collaborative and lead investigator of the I-SPY Trials stated, "The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed. We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most."

    I-SPY COVID is one of several platform studies being pursued by members of COVID R&D to test promising therapeutic candidates faster than any single company could do operating alone. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action may have a potential treatment effect in COVID-19 patients. The group is employing adaptive platform trial methodologies that enable the ability to test multiple therapies simultaneously and modify protocols in real-time based on outcomes observed.

    In addition to designing and sponsoring several platform trials, the COVID R&D Alliance is:

    • Evaluating more than 1,900 preclinical candidates against active controls to uncover which hold the greatest promise for COVID-19.
    • Reviewing promising early-stage candidates that may show potential efficacy against COVID-19, and connecting them with potential funders from venture capital or pharmaceutical developers to enable rapid advancement.
    • Working with TransCelerate's DataCelerate® platform to enable real-time data sharing and real-world evidence to inform ongoing and future studies in COVID-19, so research communities benefit from learnings and avoid duplication.
    • Operating as an interlocutor with governments, regulators, and non-governmental organizations to share insights and engage in other platform trials.

    About the I-SPY COVID Trial

    The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8 point ordinal scale of clinical severity status. The primary endpoint of I-SPY COVID is time to achieve level 4 (or less) for at least 48 hours on the WHO COVID scale. Key secondary endpoints include duration of time on ventilator and mortality.

    The I-SPY COVID Trial is sponsored and managed by Quantum Leap Healthcare Collaborative. For more information, visit www.quantumleaphealth.org or www.ispytrials.org

    About the COVID R&D Alliance

    Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for severely ill patients who need options. Future activities will expand to testing re-purposed molecules, early stage candidates, and therapeutic drug combinations.

    Additional information on the COVID R&D Alliance is available at www.CovidRDAlliance.com.

    About Cenicriviroc (CVC)

    CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in nonalcoholic steatohepatitis (NASH) known to cause liver damage including cirrhosis, liver cancer, or liver failure. These pathways have also been shown to be closely involved with the respiratory sequelae of COVID-19 and of related viral infections. Because of CVC's unique mechanisms of action, the drug has been viewed as having a potential role in the treatment of COVID-19 patients, in addition to its potential in the management liver fibrosis due to NASH, including as a part of combination-treatment strategies. CVC has been studied in both NASH patients and in HIV+ patients, and is in Phase 3 development for NASH. CVC has been granted Fast Track status in adults with liver fibrosis due to NASH, the population at highest risk of progression to cirrhosis.

    About Otezla® (apremilast)

    OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

    Otezla is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including psoriasis, psoriatic arthritis and Behçet's disease. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Amgen plans to collaborate with platform trials to investigate Otezla's ability to prevent clinical deterioration in patients with COVID-19.

    Otezla® (apremilast) U.S. INDICATIONS

    Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

    Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

    Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

    Contraindications

    • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

    Warnings and Precautions

    • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
    • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur
      • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
      • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
      • Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
    • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
      • Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
      • Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
      • Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
    • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

    Adverse Reactions

    • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
    • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
    • Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

    Use in Specific Populations

    • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
    • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
    • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

    Please click here for Otezla® Full Prescribing Information.

    About Firazyr® (icatibant injection)

    FIRAZYR® (icatibant injection) is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Indication may vary by country. It is administered by subcutaneous injection. It is thought that icatibant may ameliorate bradykinin-driven pulmonary edema by blocking the bradykinin-2 receptors.

    Firazyr® (icatibant injection) IMPORTANT SAFETY INFORMATION

    Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject icatibant injection and then go to the nearest hospital emergency room right away.

    The most common side effects of icatibant injection include:

    • redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
    • fever
    • too much of an enzyme called transaminase in your blood
    • dizziness
    • nausea
    • headache
    • rash

    These are not all of the possible side effects of icatibant injection. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 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.

    Tell your healthcare provider if you have any other medical conditions, if you are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. Icatibant injection has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if icatibant injection is right for you.

    If your symptoms continue or come back, you may repeat your icatibant injection at least 6 hours apart. Do not use more than 3 doses of icatibant injection in a 24-hour period. Tiredness, drowsiness, and dizziness have been reported following the use of icatibant injection. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

    Please see the full Prescribing Information.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including Adaptive Biotechnologies (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing better health and a brighter future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Takeda Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

    About Quantum Leap Healthcare Collaborative

    Quantum Leap Healthcare Collaborative is a 501(C)(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to the I-SPY Trials. For more information, visit www.QuantumLeapHealth.org.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/members-of-the-covid-rd-alliance-and-quantum-leap-healthcare-collaborative-enroll-first-patients-in-i-spy-covid-trial-301104431.html

    SOURCE Quantum Leap Healthcare Collaborative

    View Full Article Hide Full Article
  4. Takeda Pharmaceutical Company Limited ((TAK) ("Takeda"), today presented three abstracts at the 72nd National Hemophilia Foundation's Bleeding Disorders Conference, underscoring the need for real-world evidence (RWE) to advance patient-centric treatment in bleeding disorders.

    RWE from these studies highlight the ongoing unmet clinical need for diagnosis, personalization and treatment optimization in patients with hemophilia and von Willebrand's disease (VWD). Takeda's presence at NHF Bleeding Disorders Conference includes the following presentations, which are intended for scientific discussion only:

    Hemophilia A and B

    • Adding the patient's voice to a hemophilia specific goal menu to facilitate Goal Attainment Scaling: a qualitative study…

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda"), today presented three abstracts at the 72nd National Hemophilia Foundation's Bleeding Disorders Conference, underscoring the need for real-world evidence (RWE) to advance patient-centric treatment in bleeding disorders.

    RWE from these studies highlight the ongoing unmet clinical need for diagnosis, personalization and treatment optimization in patients with hemophilia and von Willebrand's disease (VWD). Takeda's presence at NHF Bleeding Disorders Conference includes the following presentations, which are intended for scientific discussion only:

    Hemophilia A and B

    • Adding the patient's voice to a hemophilia specific goal menu to facilitate Goal Attainment Scaling: a qualitative study
      • Many outcome measures in hemophilia lack sensitivity, and few are patient centric. A refined Goal-Hēm hemophilia-specific goal menu was evaluated by patients with hemophilia to determine relevancy to the challenges they face. Participants endorsed the clarity and relevance of the revised menu and expressed enthusiasm for further interaction with the tool. Patient-centered tools such as this have the potential to detect clinically meaningful changes for both clinicians and individuals affected by hemophilia, while improving patient outcomes.1
    • Incidence and prevalence of diagnosed and undiagnosed hemophilia A and hemophilia B in the USA
      • This study highlights the thousands of patients remaining undiagnosed in the US and the need for improvement in diagnosis and/or reporting.2

    Von Willebrand Disease

    • Analysis of Bleeding and Treatment Patterns in Children and Adolescents before and after von Willebrand Disease Diagnosis Using Data from a US Medical Claims Database
      • This abstract underscores US medical claims data that characterize the diagnosis, bleeding and treatment patterns in children and adolescents with VWD and points to the need for improved treatment and care of this patient population.3

    "Real-world evidence plays a crucial role in understanding patterns of care and the patient's holistic experience outside of rigorous clinical studies," said Michael Denne, VP of Medical Affairs, Hematology Rare Disease Unit at Takeda Pharmaceuticals. "Takeda is a passionate patient advocate and is working to provide critically-important personalized support that helps ensure that patients find, and remain on, the right therapy. These data highlight the gaps in diagnosis and treatment still prevalent in the bleeding disorders community today, and spotlight opportunities for Takeda to better support these patients."

    About Hemophilia

    Hemophilia is a challenging chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood.4 Hemophilia A is more common than hemophilia B; hemophilia A affects about 158,225 people, whereas hemophilia B affects about 31,247 people worldwide.5

    People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.4 Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.4,5

    About von Willebrand disease (VWD)

    VWD is the most common inherited bleeding disorder, affecting up to one percent of the U.S. population. VWD is caused by a deficiency or dysfunction of von Willebrand factor (VWF), one of several types of proteins in the blood that are needed to facilitate proper blood clotting.6 Due to this defect or deficiency in VWF, blood is not able to clot effectively in people with VWD, which may result in heavy menstrual periods, easy bruising or frequent nose bleeds. Bleeding caused by VWD varies greatly among patients with this disease.7

    About Takeda Hematology

    Takeda is a leader in hemophilia with the longest heritage and a market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years of experience driving innovation for patients and a broad portfolio of 11 products across multiple bleeding disorders. Our experience as leaders in hematology means we are well prepared to meet today's needs as we pursue future developments in the treatment of bleeding disorders. Together with the hematology community, we are committed to raising expectations for the future, including earlier diagnosis, earlier and better protection against bleeds, and more personalized patient care.

    About Takeda Pharmaceutical Company

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    References

    1. Roberts, J. C. et al. (2019). Adding the patient's voice to a hemophilia-specific goal menu to facilitate Goal Attainment Scaling: a qualitative study.
    2. Gretchen R. Chiu, MS1 et al. (2019). Incidence and Prevalence of Diagnosed and Undiagnosed Hemophilia A and Hemophilia B in the USA.
    3. Roberts, J. C. et al. (2019). Analysis of Bleeding and Treatment Patterns in Children and Adolescents before and after Von Willebrand Disease Diagnosis Using Data from a US Medical Claims Database.
    4. World Federation of Hemophilia. "What is hemophilia?" World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=646. Last Accessed April 2019.
    5. World Federation of Hemophilia. Report on the Annual Global Survey 2017. World Federation of Hemophilia website. http://www1.wfh.org/publications/files/pdf-1714.pdf Last Accessed April 2019.
    6. National Hemophilia Foundation. "Von Willebrand Disease." National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Von-Willebrand-Disease. Last accessed January 2020.
    7. National Hemophilia Foundation. "VWD Summit Highlights." HEMAWARE website. https://hemaware.org/story/vwd-summit-highights . Last accessed January 2020.
    8. Takeda Website. Rare Diseases. Website: https://www.takeda.com/what-we-do/areas-of-focus/rare-diseases/ Last Accessed June 2020.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takeda's estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s), any of which may cause Takeda's actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda's results, performance, achievements, or financial position, see "Item 3. Key Information—D. Risk Factors" in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda's future results.

    View Full Article Hide Full Article
View All Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of) News