• Novavax will license COVID-19 vaccine
technology to Takeda for local production and commercialization in Japan
• Matrix-M adjuvant to be supplied from Novavax
• Government of Japan will provide funding to Takeda for technology
transfer, establishment of infrastructure and scale-up of manufacturing
• Adds to Takeda’s ongoing support of influenza pandemic preparedness in Japan
GAITHERSBURG, Md. & OSAKA, Japan-Saturday 8 August 2020 [ AETOS Wire ]
(BUSINESS WIRE) --
Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company
developing next-generation vaccines for serious infectious diseases, and
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today
announced a partnership for the development, manufacturing and
commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate,
in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’
recombinant protein nanoparticle technology and includes Novavax’
proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the
Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to
support the technology transfer, establishment of infrastructure and
scale-up of manufacturing. Takeda anticipates the capacity to
manufacture over 250 million doses of the COVID-19 vaccine per year1.
“Takeda’s
leading position in Japan, technical expertise, regulatory know-how and
manufacturing capacity make the company an ideal partner to further
expand the global availability of NVX‑CoV2373,” said Stanley C. Erck,
President and Chief Executive Officer of Novavax. “We look forward to
collaborating with Takeda to rapidly develop, produce and commercialize
the vaccine in Japan.”
Novavax
and Takeda are partnering on manufacturing, clinical development and
regulatory activities in Japan. Novavax will license and transfer
manufacturing technologies to enable Takeda to manufacture the vaccine
antigen and will supply the Matrix-M adjuvant to Takeda. Takeda will be
responsible for regulatory submission to the MHLW and will produce and
distribute NVX‑CoV2373 in Japan.
“Nothing
is more important right now than protecting the world against COVID-19.
We are excited to collaborate with Novavax to bring their promising
vaccine candidate to Japan,” said Rajeev Venkayya, M.D., President of
the Global Vaccine Business Unit, Takeda. “Today’s announcement builds
upon our ongoing support of pandemic preparedness and demonstrates
Takeda’s commitment to the health and well-being of the Japanese
population.”
Novavax
will be entitled to receive payments based on the achievement of
certain development and commercial milestones, as well as a portion of
proceeds from the vaccine.
About NVX-CoV2373
NVX‑CoV2373
is a vaccine candidate engineered from the genetic sequence of
SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was
created using Novavax’ recombinant nanoparticle technology to generate
antigen derived from the coronavirus spike (S) protein and contains
Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing antibodies. In
preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies
that block binding of spike protein to receptors targeted by the virus, a
critical aspect for effective vaccine protection. In its Phase 1 data
of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally
well-tolerated and elicited robust antibody responses numerically
superior to that seen in human convalescent sera. Novavax was awarded
$1.6 billion by the federal government as part of Operation Warp Speed
(OWS), a U.S. government program to deliver millions of doses of a safe,
effective vaccine for COVID-19 to the U.S. population. The OWS funding
is being used by Novavax to complete late-stage clinical development,
including a pivotal Phase 3 clinical trial; establish large-scale
manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as
early as late 2020. The Coalition for Epidemic Preparedness Innovations
(CEPI) is also investing up to $388 million, and Department of Defense
(DoD) is investing up to $60 million of funding to advance clinical
development of NVX‑CoV2373.
About Matrix-M™
Novavax’
patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and
well-tolerated effect by stimulating the entry of antigen-presenting
cells into the injection site and enhancing antigen presentation in
local lymph nodes, boosting immune response.
About Novavax
Novavax,
Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes
improved health globally through the discovery, development, and
commercialization of innovative vaccines to prevent serious infectious
diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its
vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
NVX‑CoV2373 was generally well-tolerated and elicited robust antibody
responses numerically superior to that seen in human convalescent sera
in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its
quadrivalent influenza nanoparticle vaccine, met all primary objectives
in its pivotal Phase 3 clinical trial in older adults. Both vaccine
candidates incorporate Novavax’ proprietary saponin-based Matrix-M™
adjuvant in order to enhance the immune response and stimulate high
levels of neutralizing antibodies. Novavax is a leading innovator of
recombinant vaccines; its proprietary recombinant technology platform
combines the power and speed of genetic engineering to efficiently
produce highly immunogenic nanoparticles in order to address urgent
global health needs.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
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 bringing Better Health and a
Brighter Future to patients by translating science into
highly-innovative medicines. Takeda focuses its R&D efforts on four
therapeutic areas: Oncology, Rare Diseases, 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.
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, 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.
Novavax Forward-Looking Statements
Statements
herein relating to the future of Novavax and the ongoing development of
its vaccine and adjuvant products, including statements regarding the
rights and responsibilities of each of Novavax and Takeda in their
partnership, plans related to manufacturing [(including vaccine antigen
dose amounts)], development, regulatory and commercial activities in
Japan, potential payments to Novavax from Takeda, Novavax’ expectations
of third-party funding and anticipated timing of Novavax’ clinical trial
results are forward-looking statements. These statements may be
identified by words such as “expect,” “look forward,” “potential,”
“will” and similar references to future periods. Novavax cautions that
these forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ materially
from those expressed or implied by such statements. These risks and
uncertainties include uncertainty of success in the development and
potential commercialization of NVX-CoV2373, unexpected delays in
clinical trials or regulatory review of NVX-CoV2373, potential set backs
in scaling up manufacturing of NVX-CoV2373, adverse impacts of the
ongoing COVID-19 pandemic on Novavax’ business, Novavax’ future capital
requirements and availability of funding, as well as those risks
identified under the heading “Risk Factors” in the Novavax Annual Report
on Form 10-K for the year ended December 31, 2019, as filed with the
Securities and Exchange Commission (SEC), and updated by any Quarterly
Report on Form 10-Q, particularly the risks inherent to developing novel
vaccines. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties. We caution
investors not to place considerable reliance on the forward-looking
statements contained in this press release. You are encouraged to read
our filings with the SEC, available at sec.gov, for
a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of the
date of this document, and we undertake no obligation to update or
revise any of the statements.
Takeda Pharmaceutical Company Limited 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.
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The projected capacity is an estimate only based on current assumptions from Novavax.
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Contacts
Novavax
Investors
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022
Media
Brandzone/KOGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659
Takeda Pharmaceuticals
Media in Japan
Kazumi Kobayashi
+81 (0) 3-3278-2095
kazumi.kobayashi@takeda.com
Media Outside Japan
Amy Atwood
+1 774-571-3316
amy.atwood@takeda.com
