Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment and Prevention of Coronavi...
11 Março 2020 - 5:21PM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
initiated development of two product candidates for the treatment
and prevention of coronavirus disease (COVID-19). These product
candidates are being developed on Emergent’s hyperimmune platforms
that have a well-established safety database. The hyperimmune
platforms and related in-house manufacturing infrastructure support
several products approved by the U.S. Food and Drug Administration,
including the company’s treatments for smallpox vaccine
complications, botulism, and anthrax, VIG [Vaccinia Immune Globulin
Intravenous (Human)] (VIGIV), BAT® [Botulism Antitoxin Heptavalent
(A, B, C, D, E, F, G) - (Equine)], and Anthrasil® [Anthrax Immune
Globulin Intravenous (Human)], respectively.
Robert G. Kramer Sr., president and chief executive officer at
Emergent BioSolutions, stated, “As a company focused on public
health threats, we are committed to responding to this novel
coronavirus and will use our broad capabilities and platforms to
advance solutions. On the heels of our collaboration with an
industry partner to develop an experimental vaccine candidate for
clinical testing, we are pleased to leverage our existing
infrastructure to help expedite development of our product
candidates for COVID-19, founded on our decades of experience in
hyperimmune manufacturing.”
Hyperimmunes are polyclonal antibody therapeutics derived from
plasma that leverage the immune response in humans or animals and
can provide immediate protection from infection. COVID-HIG,
manufactured from human plasma with antibodies to SARS-CoV-2, will
be developed as a potential treatment for severe hospitalized
patients as well as protection for at-risk individuals. In
parallel, COVID-EIG, manufactured from plasma of immunized horses
with antibodies to SARS-CoV-2, will be developed as a potential
treatment for severe hospitalized patients.
“Emergent is advancing these programs based on our hyperimmune
platforms and using existing infrastructure and capabilities that
we deployed for our recently completed Phase 2 clinical trial for
our influenza hyperimmune FLU-IGIV to treat patients hospitalized
with Influenza A,” said Laura Saward, senior vice president and
therapeutics business unit head at Emergent BioSolutions. “By
leveraging our platform and capabilities that are already in place,
Emergent is in a state of readiness to develop treatment options
for COVID-19 to potentially protect healthcare workers and others
on the frontline, as well as treat individuals who have fallen
ill.”
Emergent has initiated plasma collection efforts for both human
and equine platforms with a goal of manufacturing clinical material
within the next four to five months in anticipation of beginning a
clinical study as early as the third quarter of 2020.
The company’s hyperimmune specialty plasma product manufacturing
platform has been used to create multiple products that have
obtained FDA and Health Canada approval. Emergent’s marketed
antibody therapeutics, including VIG, a treatment for smallpox
vaccine complications, and Anthrasil®, a treatment for anthrax, are
based on the human hyperimmune platform, while BAT®, the company’s
botulism anti-toxin, was developed on the equine hyperimmune
platform.
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 using our existing platforms and respond
rapidly to a related public health emergency, as well as the
anticipated production, timing, and use of COVID-19 product
candidates for clinical testing 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 programs; the timing of and ability to obtain
and maintain regulatory approvals for related product candidates;
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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