Moderna Announces New Drug Application Submitted to Import and Distribute Moderna’s COVID-19 Vaccine Candidate in Japan
Moderna (Nasdaq: MRNA) announced that Takeda Pharmaceutical (NYSE: TAK) submitted a New Drug Application (NDA) to the Japanese government for importing and distributing Moderna's COVID-19 vaccine candidate (mRNA-1273 or TAK-919). This NDA marks a significant step in the vaccine's clinical development in Japan. The Phase 1/2 study, involving 200 participants, is assessing the vaccine's safety and immunogenicity. Pending licensure, Takeda is set to distribute 50 million doses starting in the first half of 2021.
- Submission of a New Drug Application (NDA) for mRNA-1273 in Japan enhances the company's market expansion.
- Successful Phase 1/2 trial completion indicates progress in vaccine development.
- Potential distribution of 50 million vaccine doses in Japan could significantly boost revenue.
- Dependence on regulatory approval is a risk for timely vaccine distribution.
- Potential safety and efficacy concerns may arise as trial data is analyzed.
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Takeda Pharmaceutical Co., Ltd (NYSE: TAK) submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan. TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate.
“Submitting this NDA is an important step in the clinical development of our COVID-19 vaccine in Japan,” said Stéphane Bancel, Chief Executive Officer of Moderna. “The Phase 1/2 study is the first clinical trial of a Moderna product in Japan. We thank Takeda, the MHLW and the participants in the study for helping advance our goal to protect the Japanese population from COVID-19 with a vaccine.”
Takeda is conducting a placebo-controlled Phase 1/2 study designed to evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. Participants will be followed through 12 months after the second vaccination. The ClinicalTrials.gov identifier is NCT04677660. Takeda completed enrollment of this Phase 1/2 study in February, 2021. Once available, the Phase 1/2 study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.
About Moderna
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized 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 allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
Forward-Looking Statements
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 Japan’s Ministry of Health, Labour and Welfare for 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 importation and sale of 50 million doses of the COVID-19 vaccine in Japan. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “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 in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because 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 these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made 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 for updating or revising 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.
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