Business Wire

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan

Share

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced today that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan. Earlier this month, Takeda completed enrollment in the company’s Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan.

“Early in the pandemic, we made the decision to partner with other companies and leverage our substantial vaccine experience and capabilities to make COVID-19 vaccines available in Japan,” said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. “We have been pleased to see the outstanding Phase 3 efficacy data from the Moderna and Novavax programs and are excited to work with each company and the Government of Japan to help bring the pandemic to an end.”

Takeda previously announced its commitment to providing rapid and sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Takeda will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of over 250 million doses of TAK-019. The company will also import and distribute 50 million doses of TAK-919 as part of a joint partnership with Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW).

Results from the TAK-919 study are expected in the first half of 2021 and results from the TAK-019 study in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as part of the NDA filing process. Pending regulatory approval, Takeda intends to start distributing TAK-919 in the first half of 2021 and aims to start distributing TAK-019 in late 2021.

TAK-919 clinical trial

This placebo-controlled Phase 1/2 study in Japan will evaluate the safety and immunogenicity of two vaccinations of TAK-919 given 28 days apart. Each participant was assigned to receive a placebo or a 0.5 ml dose of TAK-919 at both vaccinations. The trial completed enrollment of 200 participants aged 20 years and older on February 3, 2021. Participants will be followed for 12 months after the second vaccination.

The ClinicalTrials.gov identifier for this trial is NCT04677660.

TAK-019 clinical trial

This placebo-controlled Phase 1/2 study in Japan will evaluate the safety and immunogenicity of two vaccinations of TAK-019 given 21 days apart. The first subject in the TAK-019 trial was dosed in Japan on February 24, 2021 and Takeda intends to enroll 200 participants aged 20 years and older. Each participant will be assigned to receive a placebo or a 0.5 ml dose of TAK-019 at both vaccinations. Participants will be followed for 12 months after the second vaccination.

The ClinicalTrials.gov identifier for this trial is NCT04712110.

About Takeda’s COVID-19 Efforts

Takeda is taking a comprehensive approach to treat and prevent COVID-19 through multiple activities and partnerships focused on advancing development of a variety of potential therapies and vaccines. Takeda co-founded the CoVig-19 Plasma Alliance and joined forces with other leading plasma companies to develop and manufacture a hyperimmune globulin medicine which is currently being evaluated in a clinical trial. The Alliance is also participating in The Fight Is In Us coalition and related convalescent plasma donation campaign. The company is also assessing existing Takeda products and those in development for activity against the COVID-19 virus, and has joined the COVID R&D Alliance, the IMI Care Alliance and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership. Takeda has partnered with the Government of Japan, Novavax and Moderna, to help accelerate the availability of a COVID-19 vaccine. 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 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 Genetic 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.

Contact information

Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media Outside Japan
Rachel Wiese
rachel.wiese@takeda.com
+1 917-796-8703

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

High-Quality Healthcare, Education Systems Highlighted in China's Two Sessions7.3.2021 04:41:00 CETPress release

Building Healthy China and a high-quality education system are both important content in the draft outline of the 14th Five-Year Plan (2021-2025) for national economic and social development and the long-range objectives through the year 2035, which will be reviewed by lawmakers at the ongoing National People's Congress (NPC) session. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210306005020/en/ On the second day of this year's annual session of the NPC, China's national legislature, President Xi Jinping joined a group meeting with national political advisors from the education, medical and health sectors. He attended joint group meetings with national political advisors from various sectors during the Two Sessions eight times from 2013 to 2020, hearing their comments and suggestions. Ensuring people's health Talking about work in medical and health areas, Xi reiterated holding people's health as a strategic priority, call

CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 14:02:00 CETPress release

China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi

Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 13:30:00 CETPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif

COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 10:00:00 CETPress release

Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan

International Fashion Designer Anna Chybisova Draws Major Investments Worth $9 Million for her Brand Maison d’Angelann5.3.2021 09:52:00 CETPress release

Following a series of successful market takeovers, Anna Chybisova takes another step towards success by securing another major investment for Maison D’angelann. The Gate Business Service, a private family office based out of the United Arab Emirates, has been announced as the latest investor to back Anna’s brand globally. After having invested $7 million late last year, Gate Business Service secures an additional $2 million worth of investment against a majority stake in Maison d’Angelann fashion brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005133/en/ Anna Chybisova, Fashion Designer & Owner, Maison d’Angelann (Photo: AETOSWire) Anna Chybisova’s designs and business acumen are the foremost reasons behind such heavy investments by the new partner. Reporting sales over $2 million within UAE alone and a sold-out Spring/Summer 2021 collection has strengthened the investor confidence. This growing success and custo

Xlife Sciences AG (XLS): Joint Venture With anfass Life Technologies5.3.2021 08:48:00 CETPress release

Xlife Sciences AG and Solothurn-based anfass Life Technologies AG have entered a joint venture. Hence, the jointly founded Quadira Biosciences AG has access to the 3D CoSeedis(TM) technology platform of abc biopply ag. This unique 3D cell technology enables the replication of human tissue for reliable testing and characterization of antibodies without animal testing. Xlife's technology platform for the development of antibodies will be used even more efficiently. As of today, Xlife Sciences AG has already identified 30 compounds with blockbuster potential with its antibody screening platform. These therapeutic antibodies have already shown to be safe and effective in humans. Xlife can modify these antibodies with utmost accuracy and increase the quality of the active ingredient. These are mainly advanced, highly potent antibodies with higher cytotoxic activity and improved side effect profile for cancer therapy. The target market potential of the pre-selected antibodies is in the range

Moody’s Analytics Wins IFRS 9 Solution Provider of the Year5.3.2021 08:30:00 CETPress release

Moody’s Analytics has won IFRS 9 Solution Provider of the Year in the 2021 Insurance Asset Risk Awards. It is the latest recognition for our capabilities in this space following wins for IFRS 9 – Enterprise Solution of the Year and IFRS 9 – ECL Modelling Solution of the Year at last year’s Risk Technology Awards. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304006204/en/ Central to our offering for insurers is the ImpairmentStudio™ for IFRS 9 solution, a cloud-based platform that brings together our award-winning economic scenarios, data, models, and enterprise software. Financial institutions use it to automate the credit loss impairment calculations mandated by the new IFRS 9 accounting standard. For insurers, these new financial reporting requirements call for much more granular data than was previously needed. The Moody’s Analytics offering helps them access and use all of the required data while managing and monito