Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was
awarded a 10-year contract by the Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response (ASPR) within the U.S.
Department of Health and Human Services (HHS), valued at up to a
maximum of $704 million, for advanced development, manufacturing
scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed
treatment for Ebola virus disease (EVD).
“For almost 25 years, Emergent has tackled the most serious
diseases to assist governments in their preparedness and response
strategies,” said Dr. Kelly Warfield, senior vice president,
science and development at Emergent. “Ebola virus has the ability
to emerge unexpectedly posing a risk to global health. Its elusive
nature makes it difficult to predict when and where an outbreak may
occur, which underscores the importance of preparedness efforts
against this public health threat.”
“Emergent is proud to continue providing solutions to and
partnering with the U.S. government to strengthen the medical
countermeasure infrastructure that enables the development,
manufacture, and delivery of essential treatments for deadly
diseases,” said Paul Williams, senior vice president, products
business. “We look forward to collaborating with BARDA and
executing on this long-term partnership to expand response planning
for Ebola.”
The 10-year contract consists of a base period of performance
with two option periods for advanced development valued at
approximately $121 million, and option periods for procurement of
Ebanga™ treatment over five years valued at up to $583 million. If
all option periods are exercised, the total contract value will be
valued at up to approximately $704 million.
Under the terms of the contract, Emergent will complete
activities to advance the development of Ebanga™ treatment through
post-licensure commitments, including the transfer of technology as
part of manufacturing scale-up, submission of a supplemental
Biologics License Application to the U.S. Food and Drug
Administration (FDA), and completion of stability studies.
This project has been funded in whole or in part with federal
funds from HHS; ASPR; BARDA, under contract number
75A50123C00037.
About Ebanga™ TreatmentEbanga™
(ansuvimab-zykl) treatment, formerly referred to as mAb114, is a
monoclonal antibody with antiviral activity provided through a
single infusion and was developed for the treatment of Ebola by
Ridgeback Biotherapeutics (Ridgeback Bio) under a license from
the National Institute of Allergy and Infectious Diseases.
Ridgeback Bio provided funding and operational support for clinical
testing, with additional funding received from BARDA, under
contract numbers 75A50119C00059 and 75A50120C00009, for late-stage
manufacturing and regulatory activities related to FDA approval of
Ebanga™ treatment. Ebanga™ treatment was approved by the FDA in
December 2020 for the treatment of Ebola.
Please see Full Prescribing Information for Ebanga™
(ansuvimab-zykl) here.
In 2022, Emergent and Ridgeback Bio entered into a
collaboration, whereby Emergent is responsible for the
manufacturing, sale, and distribution of Ebanga™ treatment in the
U.S. and Canada, and Ridgeback Bio serves as the Global Access
Partner for Ebanga™ treatment, ensuring it remains available to
patients in endemic countries free of charge through Ridgeback
Bio’s compassionate use program. Ridgeback’s access program
provides medical staffing and logistical support, in addition to
free medicine, so that patients receive treatment in a timely
way.
About Ebola Virus DiseaseEbola virus disease
(EVD) is severe and often fatal, with case fatality rates ranging
from 25% to 90%, and is transmitted via bodily fluids, zoonotic
transmission, or contact with contaminated surfaces. The U.S.
Department of Homeland Security has determined that EVD poses a
material threat to national health security. To augment the U.S.
government’s response capabilities, BARDA is pursuing advanced
development, licensure, and procurement of therapeutics that can be
deployed in outbreaks.
About Emergent BioSolutionsAt Emergent, our
mission is to protect and enhance life. For over 20 years, we’ve
been at work defending people from things we hope will never
happen—so we are prepared, just in case they ever do. We provide
solutions for complex and urgent public health threats through a
portfolio of vaccines and therapeutics that we develop and
manufacture for governments and consumers. We also offer a range of
integrated contract development and manufacturing services for
pharmaceutical and biotechnology customers. To learn more about how
we plan to protect or enhance 1 billion lives by 2030, visit our
website and follow us on LinkedIn, Twitter, and Instagram.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical fact, including statements
regarding the agreement with BARDA for the advanced development,
manufacturing scale-up, and procurement of Ebanga™ treatment,
including the potential exercise of option periods and any payments
in connection therewith, are forward-looking statements. We
generally identify forward-looking statements by using words like
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,”
“would,” and similar expressions or variations thereof, or the
negative thereof, but these terms are not the exclusive means of
identifying such statements. Forward-looking statements are based
on Emergent’s current intentions, beliefs, and expectations
regarding future events. Emergent cannot guarantee that any
forward-looking statement will be accurate. Readers should realize
that if underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from Emergent’s expectations. Readers 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, Emergent does 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 Emergent’s actual results to
differ materially from those indicated by any forward-looking
statements. Readers should consider this cautionary statement, as
well as the risk factors identified in Emergent’s periodic reports
filed with the U.S. Securities and Exchange Commission when
evaluating Emergent’s forward-looking statements.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280burrowsr@ebsi.com
Media Contact:Matt HartwigSenior
Director, Media Relationsmediarelations@ebsi.com
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