Novavax Announces COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India, Increasing Novavax’ Global Produc...
September 15 2020 - 7:00AM
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced an amendment to its existing agreement
with Serum Institute of India Private Limited (SIIPL) under which
SIIPL will also manufacture the antigen component of NVX‑CoV2373,
Novavax’ COVID‑19 vaccine candidate. With this agreement, Novavax
increases its manufacturing capacity of NVX-CoV2373 to
over two billion doses annually, when all planned capacity has
been brought online by mid-2021. NVX‑CoV2373 is a stable, prefusion
protein made using Novavax’ recombinant protein nanoparticle
technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.
“Today’s agreement with Serum Institute enhances
Novavax’ commitment to equitable global delivery of our COVID-19
vaccine. With this arrangement, we have now put in place a global
supply chain that includes the recently acquired Praha Vaccines and
partnerships with leading biologics manufacturers, enabling
production on three continents,” said Stanley C. Erck, President
and Chief Executive Officer of Novavax. “We continue to work with
extraordinary urgency to develop our vaccine, now in Phase 2
clinical trials, and for which we anticipate starting Phase 3
efficacy trials around the world in the coming weeks.”
The agreement with SIIPL augments a global
supply chain that will deliver over two billion doses of
NVX-CoV2373 annually as of 2021.
The antigen component of NVX-CoV2373 is being
manufactured at Novavax CZ in Bohumil, Czech Republic (formerly
Praha Vaccines), as well as at the following partnered
manufacturing sites:
- Biofabri in Spain
- FUJIFILM Diosynth Biotechnologies (FDB) in both North
Carolina and Texas in the United States
- FDB in the United Kingdom
- SIIPL in India
- SK Bioscience in the Republic of Korea
- Takeda Pharmaceutical Company Limited in Japan
Novavax’ Matrix-M adjuvant is now being
manufactured at Novavax AB in Uppsala, Sweden and the
following partnered manufacturing sites:
- AGC Biologics in the United States and Denmark
- PolyPeptide Group will manufacture two key intermediaries used
in Matrix-M in the United States and Sweden
“Signing of the manufacturing agreement with
Novavax for NVX-CoV2373 is another great milestone for both
companies, which will further strengthen our existing relationship.
SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help
ensure the supply of this most-needed vaccine,” said Adar
Poonawalla, Chief Executive Officer of Serum Institute of
India.
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 portion 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. Phase 2 clinical trials began in August 2020.
Novavax has secured $2 billion in funding for its global
coronavirus vaccine program, including up to $388 million in
funding from the Coalition for Epidemic Preparedness Innovations
(CEPI).
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.
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 Serum Institute of
India
Serum Institute of India Pvt. Ltd. was founded
in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing
life-saving immuno-biologics. Serum is the world's largest vaccine
manufacturer by number of doses produced and sold globally (more
than 1.3 billion doses). It is estimated that about 65% of the
children in the world receive at least one vaccine manufactured by
Serum Institute. Vaccines manufactured by Serum are accredited by
the World Health Organization, Geneva and are being used in
approximately 170 countries across the globe.
Serum is ranked as India's No. 1 biotechnology
company, manufacturing highly specialized lifesaving biologics like
vaccines using cutting edge genetic and cell-based technologies,
antisera and other medical specialties.
The philanthropic philosophy of Serum continues
with its work on newer vaccines and biologicals.
Learn more about Serum Institute of India at
https://www.seruminstitute.com/.
About CEPI
CEPI is an innovative partnership between
public, private, philanthropic, and civil society organizations,
launched at Davos in 2017, to develop vaccines to stop future
epidemics. CEPI has moved with great urgency and in coordination
with WHO in response to the emergence of COVID-19. CEPI has
initiated 9 partnerships to develop vaccines against the novel
coronavirus. The programs will leverage rapid response platforms
already supported by CEPI as well as new partnerships. The aim is
to advance COVID-19 vaccine candidates into clinical testing as
quickly as possible.
Before the emergence of COVID-19 CEPI's priority
diseases included Ebola virus, Lassa virus, Middle East Respiratory
Syndrome coronavirus, Nipah virus, Rift Valley Fever and
Chikungunya virus. CEPI also invested in platform technologies that
can be used for rapid vaccine and immunoprophylactic development
against unknown pathogens (Disease X).
Novavax Forward-Looking
Statements
Statements herein relating to the future of
Novavax and the ongoing development of its vaccine and adjuvant
products are forward-looking statements. 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 those identified under the
heading “Risk Factors” in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2019, and Quarterly Report on Form
8-K for the period ended June 30, 2020, as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on 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. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Contacts:
Novavax
InvestorsSilvia Taylor and Erika
Trahanir@novavax.com240-268-2022
MediaBrandzone/KOGS CommunicationEdna
Kaplankaplan@kogspr.com617-974-8659
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