Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has
been issued a task order under an existing contract with the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response (ASPR) at the U.S. Department of Health & Human
Services (HHS), to deploy its contract development and
manufacturing (CDMO) capacities, capabilities, and expertise to
support the U.S. government’s efforts to accelerate delivery of
COVID-19 vaccines.
“Emergent is proud of this expanded BARDA
partnership that symbolizes confidence in our development and
manufacturing capabilities that have served the U.S. government’s
needs for more than two decades,” said Robert G. Kramer Sr.,
president and chief executive officer of Emergent BioSolutions.
“Our longstanding record of delivering safe and effective medical
countermeasures for public health positions us to continue to help
at this critical moment by advancing COVID-19 vaccine programs of
our fellow innovators in the industry.”
This task order, valued at approximately $628
million, is being issued under the company’s 2012 contract with
BARDA that established Emergent’s Baltimore Bayview facility as a
Center for Innovation in Advanced Development and Manufacturing
(CIADM) for pandemic preparedness, and expands the partnership to
include investments in Emergent’s Baltimore Camden and Rockville
facilities, creating a U.S.-based manufacturing supply chain for
pharmaceutical and biotechnology innovators of COVID-19 vaccine
candidates.
Under the task order, Emergent will deploy its
molecule-to-market CDMO offering, committing manufacturing
capacity, valued at approximately $542.7 million, for production of
COVID-19 vaccine candidates through 2021. This award secures, on
behalf of leading COVID-19 vaccine innovators that are supported by
the U.S. government, capacity for drug substance manufacturing at
the company’s Baltimore Bayview facility and for drug product
manufacturing at the Baltimore Camden and Rockville locations. The
task order also includes an investment of approximately $85.5
million for the rapid expansion of Emergent’s viral and non-viral
CDMO drug product fill/finish capacity at the Baltimore Camden and
Rockville facilities.
Emergent’s Baltimore Bayview CIADM facility was
established through a public-private partnership with HHS in 2012
and was designed for rapid manufacturing of large quantities of
vaccines and treatments during public health emergencies. The
Baltimore Bayview 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 used. The task order extends the
CIADM collaboration to include viral and non-viral drug product
fill/finish capabilities at Emergent’s Rockville and Baltimore
Camden facilities. Activities under this task order are in addition
to the company’s previously announced collaborations for COVID-19
vaccine candidates with the Janssen Pharmaceutical Companies of
Johnson & Johnson, Novavax, and Vaxart that are currently
underway.
“Emergent’s landmark partnership with BARDA puts us
at the forefront of CDMO collaborations, elevating us to respond to
these unprecedented times,” said Syed T. Husain, SVP and CDMO
business unit head at Emergent. “This innovative solution paves the
way for pharmaceutical and biotechnology innovators with leading
COVID-19 vaccine candidates to have an established U.S. development
and manufacturing supply chain. This investment in increased
capacity and capabilities will serve the industry’s expanding
clinical and commercial pipelines more broadly, ultimately
benefiting more patients globally.”
Financial ConsiderationsThe
company will provide an update to its 2020 financial outlook
incorporating expectations related to this task order and any other
relevant information when it reports its second quarter financial
results.
About Emergent BioSolutions
Emergent 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.
Emergent’s Response to
COVID-19Emergent BioSolutions is deploying its decades of
experience in vaccine and hyperimmune development and
manufacturing, as well as its molecule-to-market contract
development and manufacturing (CDMO) services to provide
comprehensive medical countermeasure solutions in response to the
COVID-19 pandemic.
Using its established hyperimmune platforms,
Emergent is developing two investigational plasma-based treatments
- COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune
Globulin (COVID-EIG). COVID-HIG is being developed as a human
plasma-derived therapy candidate with $14.5 million in HHS funding,
and will be evaluated in at least one of the studies of the
National Institute of Allergy and Infectious Diseases, part of the
National Institutes of Health, for potential treatment of COVID-19
in severe hospitalized and high-risk patients. COVID-EIG is being
developed as an equine plasma-derived therapy candidate for
potential treatment of severe disease in humans. Both candidates
are anticipated to be in Phase 2 clinical studies in Q3 2020. These
investigational products are not approved by the U.S. Food and Drug
Administration and their safety and effectiveness have not been
established.
Emergent is deploying its CDMO capabilities,
capacities, and expertise to support the U.S. government’s Warp
Speed Program to pave the way for innovators to advance COVID-19
programs. The company has also announced collaborations with the
Janssen Pharmaceutical Companies of Johnson & Johnson, Novavax,
Inc., and Vaxart, Inc. to develop and manufacture COVID-19 vaccine
candidates. For the COVID-19 vaccine response, Emergent’s
integrated CDMO network provides development services from its
Gaithersburg facility, drug substance manufacturing at its
Baltimore Bayview facility, and drug product manufacturing at its
Baltimore Camden and Rockville facilities, all in Maryland.
For 22 years Emergent has focused on advancing
public health, and its multi-pronged approach to tackling COVID-19
demonstrates its commitment to its mission – to protect and enhance
life.
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 the total potential realizable value of the
Task Order, the timing of any of the underlying deliverables, our
ability to produce or manufacture viable COVID-19 vaccine
candidates at the prescribed scale and on the anticipated timeline,
and any other statements containing the words “believes,”
“expects,” “anticipates,” “intends,” “plans,” “estimates” and
similar expressions, 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
availability of funding for our U.S. government grants and
contracts, decisions by BARDA/ASPR/HHS to exercise any options
under the Task Order and the Contract and our 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.
Media Contact: Miko B. Neri Senior
Director, Corporate Communications 240-631-3392 NeriM@ebsi.com
Investor Contact: Robert G.
Burrows Vice President, Investor Relations 240-631-3280
BurrowsR@ebsi.com
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Emergent Biosolutions (NYSE:EBS)
Historical Stock Chart
From Apr 2023 to Apr 2024