Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has
entered into a public-private partnership with the Biomedical Advanced
Research and Development Authority (BARDA), within the Office of the
Assistant Secretary for Preparedness and Response in the U.S. Department
of Health and Human Services (HHS), to establish a Center for Innovation
in Advanced Development and Manufacturing (Center). The Center will
facilitate advanced development of chemical, biological, radiological,
and nuclear (CBRN) medical countermeasures, ensure domestic pandemic
influenza vaccine manufacturing surge capacity, share facility
construction costs, and provide workforce development training programs
to address the U.S. government’s preparedness priorities and needs.
“Emergent is pleased to enter into this long-term public-private
partnership with BARDA to help achieve our common goal of strengthening
national security and preparedness efforts,” said Daniel J. Abdun-Nabi,
president and chief executive officer of Emergent BioSolutions. “We are
honored by the U.S. government’s continued confidence in us, which is
founded on our longstanding track record of being the premier biodefense
developer and supplier of medical countermeasures. This award
underscores Emergent’s core competencies not only in product development
and manufacturing, but also our expertise in contracting with the U.S.
government and navigating the regulatory process. This partnership truly
allows us the opportunity to fulfill our mission – to protect life.”
The contract consists of an eight-year cost-reimbursable, cost-share
base period of performance, with a fixed price component, valued at
approximately $220 million, with up to 17 additional 1-year options that
will specify their own period of performance and contract value. The
eight-year base period of performance includes:
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Securing a pandemic influenza vaccine candidate and obtaining access
to all necessary Intellectual Property rights for facility process
development and manufacturing,
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Constructing additional facilities to support pandemic influenza
vaccine production, and
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Obtaining facility licensure to manufacture a pandemic influenza
vaccine at the Baltimore facility.
Under the contract, BARDA may issue service task orders for requirements
such as CBRN advanced development, pandemic influenza vaccine surge
production, facility readiness, and other activities including bulk
manufacturing, formulation, filling and finishing, storage, and shipping.
As a designated Center, Emergent is also expected to provide as options
under the contract:
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Manufacturing and delivery of an influenza vaccine in the event of a
pandemic,
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Core advanced development and manufacturing services to other
commercial partners under contract with the U.S. government for the
development of biopharmaceuticals against CBRN threats, and
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A workforce development training program to enhance and maintain the
U.S.-based ability to produce identified medical countermeasures.
The establishment of Centers that could provide advanced development and
manufacturing capabilities for CBRN medical countermeasures to address
national security and to augment public health needs on a
cost-effective, reliable and sustainable basis is a response to the
strategic imperative by HHS to have the “nimble, flexible capacity to
produce medical countermeasures rapidly in the face of any attack or
threat, known or unknown, including a novel, previously unrecognized,
naturally occurring emerging infectious disease.” This BARDA initiative
addresses a gap that was identified during the Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE) review led by HHS Assistant
Secretary for Preparedness and Response and is one of the critical
elements in HHS’ forward-looking strategy published in an August 2010
report, The Public Health Emergency Medical Countermeasures Review:
Transforming the Enterprise to Meet Long-Range National Needs.
This contract was awarded through HHS Solicitation No. 11-100-SOL-00011,
funded by the Biomedical Advanced Research and Development Authority of
the Department of Health and Human Services.
About Emergent BioSolutions Inc.
Emergent BioSolutions protects and enhances life by developing and
manufacturing vaccines and therapeutics that are supplied to healthcare
providers and purchasers for use in preventing and treating disease.
Emergent’s marketed and investigational products target infectious
diseases, oncology and autoimmune disorders. Additional information
about the company may be found at www.emergentbiosolutions.com.
Follow us on twitter @emergentbiosolu
Safe Harbor Statement
This 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 strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including any potential future securities
offering, our expected revenue growth and net earnings for 2012, and any
other statements containing the words “believes”, “expects”,
“anticipates”, “plans”, “estimates” and similar expressions, are
forward-looking statements. 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 appropriations
for BioThrax® procurement; our ability to obtain new BioThrax®
sales contracts; our plans to pursue label expansions and improvements
for BioThrax®; our plans to expand our manufacturing
facilities and capabilities; the rate and degree of market acceptance
and clinical utility of our products; the success of our ongoing and
planned development programs, preclinical studies and clinical trials;
our ability to identify and acquire or in license products and product
candidates that satisfy our selection criteria; the potential benefits
of our existing collaboration agreements and our ability to enter into
selective additional collaboration arrangements; the timing of and our
ability to obtain and maintain regulatory approvals for our other
product candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing; and
other factors identified in the company’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2012 and subsequent reports filed with
the SEC. The company disclaims any intention or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this press release.
