Novavax Expands Large-Scale Global Manufacturing Capacity
27 May 2020 - 10:00PM
Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company
developing next-generation vaccines for serious infectious
diseases, today announced the acquisition of Praha Vaccines a.s.,
part of the Cyrus Poonawalla Group, in an all cash transaction of
approximately $167 million. The acquisition includes a biologics
manufacturing facility and associated assets in Bohumil, Czech
Republic. The facility is expected to provide an annual capacity of
over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373,
Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a
stable, prefusion protein antigen made using its proprietary
nanoparticle technology and includes Novavax’ proprietary Matrix‑M™
adjuvant.
“Manufacturing capacity is a critical component
of our strategy to deliver a vaccine for the COVID-19 pandemic,”
said Stanley C. Erck, President and Chief Executive Officer of
Novavax. “This acquisition provides the vital assets required to
produce more than 1 billion doses per year. In parallel with
ramping up production at Bohumil, we will continue efforts to
expand antigen capacity in the U.S. and Asia, and increase
production of Matrix-M to match antigen capacity at multiple sites
globally.”
The acquisition includes a 150,000-square foot
state of the art vaccine and biologics manufacturing facility and
other support buildings, along with the existing employees and all
related and required infrastructure. The facility is completing a
renovation that includes Biosafety Level-3 (BSL-3) capabilities. As
part of the transaction, approximately 150 employees with
significant experience in vaccine manufacturing and support have
joined Novavax.
The acquisition of Praha Vaccines is supported
by Novavax’ funding arrangement with the Coalition for Epidemic
Preparedness Innovations (CEPI), enabling Novavax to dramatically
expand its manufacturing capacity. Novavax will work
collaboratively with the Serum Institute of India (SII), part of
the Cyrus Poonawalla Group, to increase production levels at the
Bohumil facility by the end of 2020.
“We believe Novavax and Praha reflect the ideal
complement of capabilities and expertise to advance innovative
vaccines that are vitally needed at this critical time,” said Cyrus
Poonawalla, Chairman and Founder of the Cyrus Poonawalla Group. “We
are confident that the technologies and employees are in good hands
and look forward to continuing our collaborations with
Novavax.”
About Cyrus Poonawalla
Group
Cyrus Poonawalla Group is the parent company of
Serum Institute of India Pvt. Ltd., (SII), founded in 1966 by Dr.
Cyrus Poonawalla with the aim of manufacturing life-saving
immuno-biologicals. SII is the flagship company of the group based
in India and is now the world's largest vaccine manufacturer by
number of doses produced and sold globally (more than 1.3 billion
doses per annum), which include Polio vaccine as well as
Diphtheria, Tetanus, Pertussis, Hib, Pentavalent, BCG, r-Hepatitis
B, Measles, Mumps and Rubella, and Rotavirus vaccines. It is
estimated that approximately 65 percent of children globally
receive at least one vaccine manufactured by Serum Institute.
Vaccines manufactured by the Serum Institute are accredited by the
World Health Organization, Geneva and are being used in around 170
countries across the globe in their national immunization programs,
saving millions of lives throughout the world.
In March 2020, SII and Novavax announced a
commercial license agreement for the use of Novavax’ proprietary
Matrix-M™ vaccine adjuvant with SII’s malaria vaccine candidate,
currently in a Phase 2b clinical trial.
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 efficient binding with
receptors targeted by the virus, a critical aspect for effective
vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373
initiated in May 2020, with preliminary immunogenicity and safety
results expected in July 2020. The Coalition for Epidemic
Preparedness Innovations (CEPI) is investing up to $388 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
recently initiated development of NVX-CoV2373, its vaccine
candidate against SARS-CoV-2, the virus that causes COVID-19, with
Phase 1 clinical trial results expected in July of 2020. 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.
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 manufacturing of
vaccine antigen dose amounts and timing, 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, 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. 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.
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:
Investors Novavax, Inc. Erika Trahan ir@novavax.com
240-268-2022
Westwicke John Woolford john.woolford@westwicke.com
443-213-0506
Media Brandzone/KOGS Communication Edna Kaplan kaplan@kogspr.com
617-974-8659
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