Emergent BioSolutions Signs Development and Manufacturing Agreement With Novavax for Experimental Vaccine Candidate for Coron...
10 Março 2020 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
entered into an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby
Emergent will collaborate with Novavax, utilizing its
molecule-to-market contract development and manufacturing (CDMO)
services to support bringing into the clinic Novavax’s novel
experimental vaccine candidate to protect against coronavirus
disease (COVID-19). Under the terms of the agreement, Emergent will
produce the COVID-19 experimental vaccine candidate, which is based
on the proprietary recombinant protein nanoparticle technology
platform of Novavax and utilizing their proprietary Matrix-M™
adjuvant to enhance immune responses. Emergent has initiated work
for this program anticipating that the COVID-19 experimental
vaccine candidate will be used in a Phase 1 clinical study within
the next four months.
Robert G. Kramer Sr., president and chief executive officer at
Emergent BioSolutions, stated, “We are pleased with our Novavax
collaboration, which reflects Emergent’s commitment to advancing
potential solutions to combat coronavirus disease. As we provide
our CDMO services, backed by our established track record as a
trusted partner to governments, industry, and non-government
organizations, we leverage our long history in vaccines and
therapeutics development and manufacturing, as well as our broad
capabilities focused on medical countermeasures for emerging
infectious diseases. The increasing threat of COVID-19 requires a
comprehensive response and we continue to evaluate various vaccine,
therapeutic, and CDMO approaches to enable us to marshal resources
to make a meaningful impact on this global public health
emergency.”
In support of the COVID-19 experimental vaccine candidate’s
progression into the clinic, Emergent has mobilized its integrated
clinical and commercial development and manufacturing network to
provide development services out of its Gaithersburg, Md location
as well as manufacturing services out of its two Baltimore, Md
facilities. Drug substance will be produced at the
Baltimore/Bayview location, which is designated by the U.S.
Department of Health and Human Services (HHS) as a Center for
Innovation in Advanced Development and Manufacturing (CIADM), while
drug product will be produced at the Baltimore/Camden location.
“Emergent is proud to demonstrate its ability to rapidly deploy
capabilities, capacities, and expertise as part of our
molecule-to-market CDMO offering to support the development and
commercialization of essential medicines,” said Syed T. Husain,
senior vice president and CDMO business unit head at Emergent
BioSolutions. “Always at the core of our response is our desire to
fulfill our mission – to protect and enhance life.”
About Emergent BioSolutionsAs a global life
sciences company whose mission is to protect and enhance life, we
provide solutions that target public health threats. Through our
specialty products and services as well as our social
responsibility efforts, we aspire to build healthier, safer
communities and deliver peace of mind to our patients and customers
so they can focus on what’s most important in their lives. For more
information visit www.emergentbiosolutions.com. Find us on LinkedIn
and follow us on Twitter @emergentbiosolu and Instagram
@life_at_emergent.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, including statements
regarding our ability to advance potential solutions to combat
coronavirus disease and the anticipated production and use of the
COVID-19 experimental vaccine candidate in a Phase 1 clinical study
within the next four months, are forward-looking statements. These
forward-looking statements are based on our current intentions,
beliefs and expectations regarding future events. We cannot
guarantee that any forward-looking statement will be accurate.
Investors should realize that if underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual
results could differ materially from our expectations. Investors
are, therefore, cautioned not to place undue reliance on any
forward-looking statement. Any forward-looking statement speaks
only as of the date of this press release, and, except as required
by law, we do not undertake to update any forward-looking statement
to reflect new information, events or circumstances.
There are a number of important factors that could cause the
company's actual results to differ materially from those indicated
by such forward-looking statements, including the success of the
planned development program; the timing of and ability to obtain
and maintain regulatory approvals for the product candidate; and
our commercialization, marketing and manufacturing capabilities.
The foregoing sets forth many, but not all, of the factors that
could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this
cautionary statement, as well as the risk factors identified in our
periodic reports filed with the SEC, when evaluating our
forward-looking statements.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
Media Contact:Lynn KiefferVice
President, Corporate
Communications240-631-3391KiefferL@ebsi.com
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