Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been
advised by the Office of the Biomedical Advanced Research and
Development Authority (BARDA) that the Request for Proposal (RFP) for
the procurement of rPA vaccines has been cancelled in favor of a Broad
Agency Announcement (BAA) for rPA vaccine development. According to
BARDA officials, BARDA took this action after a technical evaluation
panel determined that none of the vaccine developers submitting
proposals could meet the Project BioShield statutory requirement of
having a product ready for licensure within 8 years.
Simultaneously, BARDA issued an amendment to BAA 09-34 to enable
companies to submit proposals to obtain development funding for rPA
vaccine candidates. The due date for all proposals is February 1, 2010.
During a meeting with company officials today, BARDA strongly encouraged
Emergent to submit a proposal to this BAA. Emergent intends to submit
its proposal by the end of this year.
This decision by BARDA has no impact on the company’s $400 million
procurement contract with the Centers for Disease Control and Prevention
(CDC) for the manufacture and delivery of 14.5 million doses of BioThrax®
into the Strategic National Stockpile (SNS). The company is currently
delivering BioThrax under this contract and expects to complete
deliveries by September 2011. BioThrax is the only vaccine licensed by
the FDA for the prevention of anthrax disease.
"With this action, BioThrax remains a critical and long-term
countermeasure for the US government,” said Fuad El-Hibri, chairman and
chief executive officer of Emergent BioSolutions. "In addition, based
upon encouragement by the USG, we believe our rPA vaccine is
well-positioned to obtain a development contract under this BAA. Our
anthrax franchise solidifies Emergent as a leader in the development and
supply of anthrax medical countermeasures.”
Emergent has recently resumed BioThrax scale-up activities within its
new 50,000 sq. ft. state-of-the-art manufacturing facility in Lansing.
In addition, BARDA and Emergent are in discussions for a separate
contract under which BARDA would fund scale-up and related activities to
obtain FDA licensure for large-scale production of BioThrax in this new
facility. This new facility is designed as a campaignable, multi-product
facility capable of producing up to 30 million doses of BioThrax per
annum. With the addition of a second train, the capacity of the facility
could be doubled to up to 60 million doses per annum.
"This is an exciting development because it positions BioThrax as the
sole anthrax vaccine for USG procurement for at least the next eight
years,” said Daniel J. Abdun-Nabi, president and chief operating
officer, Emergent BioSolutions. "We believe that BioThrax will remain a
premier product based on its recent enhancements, such as four-year
dating, a reduced vaccination schedule and intramuscular route of
administration, together with the potential for a further reduction in
the vaccination schedule to a 3-dose primary series with a 3-year boost.
BioThrax continues to be the product of choice for the USG and other
customers seeking to address the anthrax threat.”
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and
therapeutics that assist the body’s immune system to prevent or treat
disease. Emergent’s marketed product, BioThrax® (Anthrax
Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and
Drug Administration for the prevention of anthrax disease. Emergent’s
development pipeline includes programs focused on anthrax, botulism,
tuberculosis, typhoid, hepatitis B and chlamydia. Additional information
may be found at www.emergentbiosolutions.com
and www.biothrax.com.
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 2009, 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 September 30, 2009 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.
