EMERGENT BIOSOLUTIONS SIGNS DEVELOPMENT AND MANUFACTURING AGREEMENT WITH VAXART FOR THEIR EXPERIMENTAL ORAL VACCINE CANDIDATE...
March 18 2020 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
entered into an agreement with Vaxart, Inc. (Nasdaq: VXRT), a
clinical-stage biotechnology company, whereby Emergent has agreed
to utilize its molecule-to-market contract development and
manufacturing (CDMO) services to develop and manufacture Vaxart’s
experimental oral vaccine candidate for coronavirus disease
(COVID-19). Development services will begin immediately, and upon
Vaxart’s election, Emergent agrees to produce clinical material
expected to enable Vaxart to initiate a Phase 1 clinical study
anticipated early in the second half of 2020. Vaxart’s oral
recombinant vaccine candidate is based on its proprietary VAAST™
platform.
“Emergent is pleased to deploy our nimble CDMO expertise to
support fellow innovators, like Vaxart, and advance an experimental
COVID-19 vaccine candidate,” said Syed T. Husain, senior vice
president and CDMO business unit head at Emergent BioSolutions. “We
look forward to applying our broad molecule-to-market services,
including our ability to work with a multitude of delivery systems,
execute under expedited timelines, and meet Vaxart’s potential need
for future scalability and large-scale capacity for commercial
quantities.”
Under the terms of the agreement, Emergent will provide
development services out of its Gaithersburg, Md. location and
manufacture drug substance at its Bayview facility in Baltimore,
Md., designated a Center for Innovation in Advanced Development and
Manufacturing (CIADM) by the U.S. Department of Health and Human
Services. Emergent’s Bayview CIADM is the same facility used to
manufacture drug substance for the company’s recently announced
Novavax collaboration. The facility has the capacity to produce
tens to hundreds of millions of doses of vaccine on an annual
basis, based upon the platform technology being leveraged.
Additionally, it has the unique capability of producing at clinical
scale, to get vaccine candidates quickly into the clinic, and in
parallel, scaling up to produce commercial volumes to meet customer
demand.
“I’m pleased that we are joining forces with an experienced
manufacturer such as Emergent to help advance our oral COVID-19
vaccine to the clinic,” said Wouter Latour, MD, chief executive
officer of Vaxart. “We believe an oral vaccine administered using a
room temperature-stable tablet may offer enormous logistical
advantages in the roll-out of a large vaccination campaign, and
Emergent is a great partner to help in this endeavor.”
About Emergent BioSolutionsEmergent
BioSolutions is a global life sciences company whose mission is to
protect and enhance life. Through our specialty products and
contract development and manufacturing services, we are dedicated
to providing solutions that address public health threats. Through
social responsibility, we aim to build healthier and safer
communities. We aspire to deliver peace of mind to our patients and
customers so they can focus on what’s most important in their
lives. In working together, we envision protecting or enhancing 1
billion lives by 2030. 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 as well as the anticipated production level and
use of the COVID-19 experimental vaccine candidate in a Phase 1
clinical study in the expected timeframe, 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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