Business Wire

Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan

Share

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)(“Takeda”) today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. The approval is based on positive clinical data from Takeda’s Phase 1/2 immunogenicity and safety clinical trial of Moderna’s COVID-19 vaccine in Japan, which showed an immune response consistent with results from Moderna’s pivotal Phase 3 COVE trial conducted in the United States. Takeda plans to begin distribution in Japan immediately.

“This is an important step in Takeda’s support of Japan’s pandemic response,” said Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda. “Moderna’s vaccine has demonstrated an excellent safety and effectiveness profile to date, and we are excited to make it available to the Japanese population.”

The approval is the result of a three-way agreement announced in October 2020 with Moderna and Government of Japan’s Ministry of Health Labour and Welfare (MHLW) to distribute 50 million doses of TAK-919 in Japan in the first half of 2021. Takeda also entered into a collaboration with Novavax to develop, manufacture and commercialize Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan.

Takeda’s efforts to bring the COVID-19 Vaccine Moderna Intramuscular Injection and Novavax’ vaccine candidates to Japan are supported by the MHLW and the Japan Agency for Medical Research and Development (AMED).

TAK-919 Clinical Trialand Results

Takeda is conducting a placebo-controlled Phase 1/2 study in Japan to evaluate the safety and immunogenicity of two vaccinations of TAK-919 given 28 days apart. Takeda enrolled 200 participants aged 20 years and older. Each participant was assigned to receive a placebo or a 0.5 ml dose of TAK-919 at both vaccinations. Participants will be followed for 12 months after the second vaccination.

This interim analysis showed that binding antibody and neutralizing antibody titers were elevated at 28 days after the second dose in 100% of people vaccinated with two 0.5ml doses of TAK-919 given 28 days apart. The vaccine candidate was generally well-tolerated with no significant safety concerns reported. Takeda intends to publish additional data in a peer-reviewed journal.

About Takeda’s COVID-19 Efforts

Takeda is taking a comprehensive approach to treat and prevent COVID-19 today, and future pandemics through multiple activities and partnerships including, but not limited to:

  • Hyperimmune globulin: Takeda co-founded the CoVIg-19 Plasma Alliance and joined forces with other leading plasma companies to evaluate a hyperimmune globulin medicine in a global clinical trial. While the data did not meet its endpoints, the program has contributed to the scientific understanding of antibody-based treatment to address the virus and highlighted the broader therapeutic value and importance of plasma to treat rare diseases.
  • Additional therapeutics: The company has assessed existing Takeda products for activity against the COVID-19 virus and co-founded the COVID R&D Alliance. In addition, Takeda has joined the Innovative Medicines Initiative (IMI) CARE consortium, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership and the COVID RED project.
  • Vaccines: Takeda has partnered with the Government of Japan, Novavax and Moderna, to help accelerate the availability of COVID-19 vaccines. We are leveraging our extensive and well-established global manufacturing and supply capabilities and building upon our existing influenza pandemic preparedness efforts in Japan. Takeda also announced a mutual agreement with IDT Biologika GmbH (IDT) to utilize capacity at IDT for three months previously reserved for Takeda’s dengue vaccine candidate to manufacture the single-shot COVID-19 vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson. Takeda supports our partners and alliances in a shared goal to rapidly discover, develop and deliver effective treatments and vaccines for COVID-19 and ensure preparedness for future pandemics.

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, COVID-19, 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.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, 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.

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. 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.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Japanese Media
Ryoko Matsumoto
ryoko.matsumoto@takeda.com
+81 (0) 3-3278-3414

Media Outside Japan
Catherine Wilson
catherine.wilson@takeda.com
+1 440-488-6242

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Verimatrix Protects Recode Health’s STRIVE Benefits Mobile App16.6.2021 17:45:00 CEST | Press release

Regulatory News: Verimatrix, (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced its application shielding solutions were selected by Oakland, California-based Recode Health to protect its STRIVE Benefits mobile app. Serving as the SaaS benefits communication platform of choice for thousands of businesses throughout the United States, STRIVE’s mobile app aims to modernize employer-employee relations by seamlessly educating employees so that they stay ahead of the curve and have fingertip access to their benefits guides, balances, financial information and other customizable data. Due to the sensitive nature of the information within the app, such as telemedicine and Rx integrations to save on healthcare costs, the STRIVE management team prioritizes its cybersecurity stance and looked to ensure that its mobile app is as secure as possible. “The protection of employer and employee data is paramount at STRIVE,

Biolog-id Partners With AirMed to Help Enhance Visibility, Availability, and Traceability of Life-saving Blood Components16.6.2021 17:18:00 CEST | Press release

Biolog-id LLC, a developer and service provider of connected healthcare solutions, announced today its partnership with AirMed – one of the first air medical transport programs in the US. As part of this partnership, biolog-id’s cutting-edge technology will provide digital visibility to the inventory of red blood cells and liquid plasma across 5 locations in the state of Utah, covering one of the largest geographical areas in the nation, routinely transporting patients not only from Utah, but also from Colorado, Wyoming, Nevada, Montana, and Idaho. Biolog-id’s blood components management platform will support the inventory replenishment of the different bases, as well as the traceability and documentation of the units selected by the teams at the AirMed bases. “We are pleased to cooperate with the biolog-id team on the deployment of this technology across our operation,” said Cory Cox, AirMed Outreach Coordinator & Flight Paramedic at AirMed. “We are committed to delivering the highest

Moody’s ESG Solutions Launches Bespoke Dataset to Help Market Participants Meet SFDR Requirements16.6.2021 17:10:00 CEST | Press release

Moody’s ESG Solutions today launched a bespoke ESG data solution to help market participants meet the European Union (EU) Sustainable Finance Disclosure Regulation (SFDR) requirements. Harnessing Moody’s ESG Solutions’ analytical rigor and advanced data capture processes, the product was built from the ground up, making it one of only a few purpose-built SFDR data solutions in the market. In effect since March 2021, SFDR introduces disclosure requirements on a set of Principle Adverse Impact (PAI) indicators, which outline the environmental, social and governance (ESG) factors that lead to adverse sustainability impacts. PAI disclosures will become mandatory for all financial market participants, including advisers, from 2022 as part of the EU’s strategy to combat greenwashing and incentivize funding of green projects. “We are committed to advancing sustainability objectives and providing essential data that market participants can rely on,” said Sabine Lochmann, Global Head of Moody’s

Piper Sandler Advises EverArc on its Acquisition of Perimeter Solutions16.6.2021 16:18:00 CEST | Press release

Piper Sandler & Co. chemicals & materials investment banking group (The Valence Group) has advised EverArc Holdings on its announced acquisition of 100% of Perimeter Solutions from SK Capital. EverArc Holdings Limited (LSE: EVRA / EVWA) has entered into a definitive agreement with SK Invictus Holdings S.à.r.l. an affiliate of funds advised by SK Capital Partners, to acquire 100% of SK Invictus Intermediate S.à.r.l., the ultimate parent company of Perimeter Solutions, a leading global manufacturer of high-quality firefighting products and lubricant additives, for total consideration of approximately $2 billion, consisting of cash and preferred shares, subject to customary closing conditions. The transaction is expected to close in Q4 2021. EverArc Holdings Limited (LSE: EVRA / EVWA) is a publicly-listed acquisition company that was formed in November 2019 to undertake an acquisition of a target company or business. Perimeter is a leading global manufacturer of high-quality firefighting

UVD Robots Selected by Global Facility Management Company ISS to Provide Autonomous Disinfection Robots16.6.2021 15:02:00 CEST | Press release

Today, Blue Ocean Robotics the manufacturer of UVD Robots for autonomous UV-C disinfection announced that it was selected by ISS World Services, a world leading global workplace experience and facility management company, to provide autonomous robots for disinfection as part of ISS’ global offering. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210616005504/en/ UVD Robots are helping to ensure outstanding cleaning and disinfection excellence. Unlike many stationary disinfection systems, the UVD Robot is a mobile, fully autonomous robot integrating UV-C light to disinfect against all known bacteria and viruses including Covid-19 not only on surfaces, but the air as well, providing a fully comprehensive infection control and prevention solution. UVD Robots enable facilities to reduce disease transmission by eliminating 99.99 percent of bacteria and viruses in any room. The robots have been rolled out to more than 70 countries

Auth0 Releases State of Secure Identity Report, Highlighting the Most Pervasive Threats to Digital Identities16.6.2021 15:01:00 CEST | Press release

Auth0, the modern identity platform, today announced the launch of its inaugural security report: The State of Secure Identity. This detailed report highlights key areas of concern for security professionals responsible for managing digital identities, including the exponential rise of credential stuffing attacks (automated attempts to compromise a large number of user accounts with stolen credentials), fraudulent registrations, and the widespread use of breached credentials. Recent headlines and high-profile cyber attacks give today’s security professionals a wide swath of serious threats to worry about. The primary goal of cybercriminal activity is to access critical resources, systems, and personal data, yet systems that can be put into place to minimize the risk of attack — like identity management — often get deprioritized. Lack of budget, resourcing, or attention on managing digital identities give threat actors a prime opportunity to take advantage of these discrepancies and sur

Ray Fernandez-Andes Named CFO at Next Level Aviation16.6.2021 15:00:00 CEST | Press release

Seasoned finance executive Ray Fernandez-Andes has been named Chief Financial Officer at Next Level Aviation, a leader in the global distribution of used serviceable material (USM) for commercial aircraft and jet engines. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210616005177/en/ Ray Fernandez-Andes has been named Chief Financial Officer of Next Level Aviation. He will help create financial strategies to support the company’s planned growth in the coming years, both organically and through acquisition. (Photo: Business Wire) Fernandez-Andes brings a high level of finance expertise in the airline and commercial aviation aftermarket to NLA. He has extensive experience in improving financial results, providing strategic advice for growth and capital deployment, as well as managing banking and investor relationships. Fernandez-Andes is a certified public accountant (CPA) in the state of Florida, and a former auditor at Arth