CAMBRIDGE, Mass .– (BUSINESS WIRE) – Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced that Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) has submitted a new drug application to the Japanese government. Ministry of Health, Labor and Welfare (MHLW) to import and distribute Moderna’s candidate vaccine against COVID-19 (mRNA-1273 or TAK-919) in Japan. TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate.
“The submission of this NDA is an important step in the clinical development of our COVID-19 vaccine in Japan,” said Stéphane Bancel, CEO of Moderna. “The phase 1/2 study is the first clinical trial of a Moderna product in Japan. We thank Takeda, the MHLW, and study participants for helping advance our goal of protecting the Japanese population from COVID-19 with a vaccine. ”
Takeda is leading a placebo controlled Phase 1/2 to study designed to assess the safety and immunogenicity of two vaccinations of mRNA-1273 at a dose of 100 μg administered 28 days apart in 200 participants aged 20 years and older in Japan. Participants will be followed for 12 months after the second vaccination. The ClinicalTrials.gov identifier is NCT04677660. Takeda registration completed of this phase 1/2 study in February 2021. Once available, the results of the Phase 1/2 study will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
Takeda and Moderna before ad this Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate from the first half of 2021, pending approval in Japan.
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the promising but still unproven field of messenger RNA (mRNA), to a company with its first drug having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for diseases infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 24 development programs are underway in these therapeutic areas, with 13 programs having entered the clinic. Moderna was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the submission of a new drug application to the Japanese Ministry of Health, Labor and Employment. Wellbeing for the mRNA-1273, Moderna’s COVID -19 vaccine candidate, the conduct of clinical trials for the COVID-19 vaccine in Japan, the potential regulatory approval of the COVID-19 vaccine by Japanese regulators and the import and sale of 50 million doses of the COVID-19 vaccine in Japan. In some cases, forward-looking statements may be identified by words such as “will”, “may”, “should”, “could”, “expects”, “intends”, “intends”, “aims”, “ provides, “” Believe “,” estimate “,” predict “,” potential “,” continue “or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements contained in this press release are not promises or guarantees, and you should not place undue reliance on such forward-looking statements as they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, but are not limited to: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology used by Moderna is still under development and implementation; the safety, tolerability and efficacy profile of Moderna COVID-19 vaccine observed to date may change unfavorably in ongoing analyzes of trial data or post-marketing; the Moderna COVID-19 vaccine may prove to be less effective against variants of the SARS-CoV-2 virus, or the Company may not be successful in developing future versions of its vaccine against these variants; despite ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with the company’s regulatory approval strategies, components of our deposits, such as clinical trial designs, conduct and methodologies, or sufficiency of data submitted; Moderna may experience delays in meeting manufacturing or supply deadlines or disruptions in its distribution plans for the Moderna COVID-19 vaccine; whether and when biologic license applications and / or other emergency use authorization applications may be made in various jurisdictions and ultimately approved by regulatory authorities; potential negative impacts from the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain disruptions, adverse effects on health systems and disruption the world economy; and other risks and uncertainties described under “Risk Factors” in Moderna’s latest annual report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.