DUBLIN, Sept. 25, 2020 /CNW/ -- Endo International plc
(NASDAQ: ENDP) today announced that its subsidiary, Par Sterile
Products, LLC (Par Sterile) has entered into a non-exclusive
agreement with Novavax, Inc. to provide fill-finish manufacturing
services at its plant in Rochester,
Michigan for NVX-CoV2373, Novavax' COVID-19 vaccine
candidate.
Under the terms of the agreement, Par Sterile's Rochester facility has begun production of
NVX-CoV2373 final drug product, with initial batches to be used in
Novavax' pivotal Phase 3 clinical trial in the United States. Par Sterile will also
fill-finish NVX-CoV2373 vaccine intended for commercial
distribution in the United States.
Financial and other terms of the agreement were not
disclosed.
"This agreement puts an important piece in place as we finalize
our supply chain for the U.S. clinical trial and eventually,
commercial distribution of NVX-CoV2373, our nanoparticle vaccine
adjuvanted with Matrix-M™," said Stanley C.
Erck, President and CEO, Novavax. "Endo's partnership and
expertise are enabling rapid delivery of the vaccine for pivotal
clinical testing, which we expect to get underway very soon."
"We are very pleased to help bring Novavax' COVID-19 vaccine to
the public," said Blaise Coleman,
President and CEO of Endo. "Our Rochester, Michigan facility has a long
history of manufacturing critical vaccines and sterile injectable
products for the U.S. market and we are proud to partner with
Novavax on such a critical initiative. This partnership further
underscores Endo's commitment to helping everyone we serve live
their best life through the delivery of life-enhancing
therapies."
NVX-CoV2373 is currently in multiple Phase 2 clinical trials. A
Phase 2 clinical trial to evaluate the safety and immunogenicity of
NVX-CoV2373 began in August 2020
in the United States and Australia building on
positive Phase 1 results and expanding to include older adults. A
Phase 2b clinical trial to assess
efficacy began in South Africa in August 2020. Interim data for these trials is
expected before the end of 2020.
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 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 Endo International plc
Endo International plc
(NASDAQ: ENDP) is a specialty pharmaceutical company committed to
helping everyone we serve live their best life through the delivery
of quality, life-enhancing therapies. Our decades of proven success
come from a global team of passionate employees collaborating to
bring the best treatments forward. Together, we boldly transform
insights into treatments benefiting those who need them, when they
need them. Endo has global headquarters in Dublin, Ireland and U.S. headquarters in
Malvern, Pennsylvania. Learn more
at www.endo.com.
Forward Looking Statement
This press release contains
certain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 and Canadian
securities legislation, including the statements by Messrs. Erck
and Coleman and other statements regarding product potential,
clinical trial outcomes, quality, availability and affordability.
Statements including words such as "believes," "expects,"
"anticipates," "intends," "estimates," "plan," "will," "may," "look
forward," "intend," "guidance," "future" or similar expressions are
forward-looking statements. Because these statements
reflect Endo's and Novavax's current views, expectations
and beliefs concerning future events, they involve risks and
uncertainties. Although Endo and Novavax believe that
these forward-looking statements and information are based upon
reasonable assumptions and expectations, readers should not place
undue reliance on them, or any other forward-looking statements or
information in this news release. Investors should note that many
factors, as more fully described in the documents filed
by Endo and Novavax with the Securities and Exchange
Commission and, in Endo's case, with securities regulators
in Canada on the System for Electronic Document Analysis
and Retrieval, including under the caption "Risk Factors"
in Endo's and Novavax's Form 10-K, Form 10-Q and Form 8-K
filings, and as otherwise enumerated herein or therein, could
affect Endo's and Novavax's future results and could
cause Endo's and Novavax's actual results to differ
materially from those expressed in forward-looking statements
contained in this communication. The forward-looking statements in
this press release are qualified by these risk
factors. Endo and Novavax assume no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise, except as may
be required under applicable securities laws.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/endo-announces-fill-finish-manufacturing-and-services-agreement-for-novavax-covid-19-vaccine-candidate-301138018.html
SOURCE Endo International plc