OSAKA, Japan – (BUSINESS WIRE) – Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) (“Takeda”) announced today that the Ministry of Health, Labor and Welfare (MHLW) has granted special approval under section 14-3 of the Pharmaceuticals and Welfare Act. medical devices for emergency use of Moderna’s COVID-19 mRNA vaccine, TAK-919, now known as Moderna Intramuscular Injection COVID-19 vaccine, 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 the results of the 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 for Japan’s response to the pandemic,” said Rajeev Venkayya, president of the global vaccine business unit at Takeda. “Moderna’s vaccine has demonstrated an excellent safety and efficacy profile to date, and we are delighted to make it available to the Japanese population.”
The approval is the result of a tripartite agreement announced in October 2020 with Moderna and the Japanese Ministry of Health, Labor and Welfare (MHLW) to distribute 50 million doses of TAK-919 in Japan in the first half of the year. 2021. Takeda also has entered into a collaboration with Novavax to develop, manufacture and market Novavax’s COVID-19 vaccine candidate (TAK-019) in Japan.
Takeda’s efforts to bring the COVID-19 Moderna Intramuscular Injection vaccine and Novavax vaccine candidates to Japan are supported by MHLW and the Japan Agency for Medical Research and Development (AMED).
TAK-919 clinical trial and results
Takeda is conducting a phase 1/2 placebo-controlled study in Japan to evaluate the safety and immunogenicity of two TAK-919 vaccinations 28 days apart. Takeda has entered 200 participants aged 20 and over. Each participant received either a placebo or 0.5 ml dose of TAK-919 in both vaccinations. Participants will be followed for 12 months after the second vaccination.
This interim analysis showed that the titers of binding and neutralizing antibodies were elevated 28 days after the second dose in 100% of people vaccinated with two 0.5 ml doses of TAK-919 administered at 28 days after the second dose. interval. The vaccine candidate was generally well tolerated and no significant safety concerns were reported. Takeda intends to publish additional data in a peer-reviewed journal.
About Takeda’s COVID-19 Efforts
Takeda takes a holistic approach to addressing and preventing COVID-19 today and future pandemics through multiple activities and partnerships, including, but not limited to:
- Hyperimmunized globulin: Takeda co-founded the CoVIg-19 Plasma Alliance and partnered with other leading plasma companies to evaluate a hyperimmune globulin drug in a global clinical trial. Although the data did not meet its targets, the program contributed to the scientific understanding of antibody therapy to fight the virus and highlighted the broader therapeutic value and importance of plasma to treat rare diseases.
- Additional therapeutics: The company evaluated the activity of existing Takeda products against the COVID-19 virus and co-founded the COVID R&D Alliance. In addition, Takeda joined the CARE consortium of the Innovative Medicines Initiative (IMI), the Accelerate the partnership on therapeutic interventions and COVID-19 vaccines (ACTIV) 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 on our influenza pandemic preparedness efforts in Japan. Takeda also announced a mutual agreement with IDT Biologika GmbH (IDT) to use IDT’s three-month capacity previously reserved for Takeda’s dengue vaccine candidate to manufacture the COVID-19 single-injection vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. Takeda supports our partners and alliances with a common goal: to discover, develop and rapidly deliver effective treatments and vaccines against COVID-19 and to ensure preparedness for future pandemics.
Takeda’s commitment to vaccines
Vaccines prevent 2-3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has provided vaccines to protect the health of the people of Japan. Today, Takeda’s global vaccine business is applying innovation to fight some of the world’s most difficult infectious diseases, such as dengue, COVID-19, Zika and norovirus. The Takeda team brings exceptional experience and a wealth of knowledge in the development, manufacture and global access of vaccines to advance a vaccine portfolio to meet 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 discovering and delivering 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 investments in R&D in plasma-derived therapies and vaccines. We are focused on developing highly innovative medicines that help make a difference in people’s lives by pushing the frontier of new treatment options and leveraging our enhanced collaborative research and development engine and capabilities to create a robust and varied pipeline. Our employees are committed to improving the quality of life for patients and working with our healthcare partners in approximately 80 countries. For more information visit https://www.takeda.com.
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”) in connection with this release. This press release (including any oral briefing and any related question and answer) 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, exchange, sell or otherwise dispose of securities or seek a vote or approval in any jurisdiction. No shares or other securities are offered to the public through this press release. No offer of securities will be made in the United States except pursuant to registration under the US Securities Act of 1933, as amended, or an exemption therefrom. This press release is given (together with any additional information that may be provided to the recipient) on the condition that it is intended to be used by the recipient for informational purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any breach of these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda has direct and indirect investments are separate entities. In this press release, “Takeda” is sometimes used for convenience when references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “our” and “our” are also used to designate subsidiaries in general or those which work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any material 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. , goals 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” “anticipate”, “estimate”, “plan” or similar expressions or their negative. 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: economic circumstances surrounding the global business Takeda, including general economic conditions in Japan and the United States; competitive pressures and developments; changes in applicable laws and regulations; the success or failure of product development programs; the decisions of the regulatory authorities and their timetable; fluctuations in interest rates and exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, such as the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in the countries in which Takeda operates, or on other aspects of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not essential to Takeda’s business and the timing of such divestments; and other factors identified in Takeda’s latest annual report on Form 20-F and other Takeda reports filed with the United States Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/ reports / sec-filings / or to www.sec.gov. Takeda does not undertake to update any forward-looking statements contained in this press release or any other forward-looking statements it may make, except to the extent required by law or stock exchange rules. Past performance is not an indicator of future results and Takeda’s results or statements in this press release may not be indicative and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
This press release contains information on products which may not be available in all countries, or which may be available under different brands, for different indications, at different strengths or at different strengths. Nothing contained in this material should be construed as a solicitation, promotion or advertisement for prescription drugs, including those in development.