Moderna Announces New Drug Application Submitted to Import and Distribute Moderna’s COVID-19 Vaccine Candidate in Japan
March 05 2021 - 1:30AM
Business Wire
50 million doses of Moderna’s COVID-19 vaccine
candidate expected to be distributed beginning in the first half of
2021, pending licensure in Japan
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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Moderna
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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