Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S.
Department of Health and Human Services (HHS) issued an additional
amendment to its request for proposal for an Anthrax Recombinant
Protective Antigen (rPA) Vaccine for the Strategic National Stockpile.
This new amendment, which follows an amendment previously issued on
April 15, 2009 requesting that all bidders submit a comprehensive plan
outlining the regulatory strategy to FDA for review, extends the
deadline for submission of such a plan to June 15. This new amendment
applies to all bidders in competitive range for the rPA contract. The
original amendment required submissions within 15 days of April 15th,
the date the amendment was first issued.
Daniel J. Abdun-Nabi, president and chief operating officer of Emergent
BioSolutions, stated, "We are confident in our submission package that
we had been planning to submit in satisfaction of the original deadline.
With that said, we fully support HHS’s decision to grant additional time
to submit a development plan package for FDA review.”
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. 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.
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statements, other than statements of historical fact, including
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of, and the potential for successful outcomes resulting from future
product development efforts and our ability to obtain additional funding
from the U.S. government, our plans to expand our manufacturing
facilities and capabilities; the rate and degree of market acceptance
and clinical utility of our products; and other factors identified in
the company's annual report on Form 10-K for the year ended December 31,
2008 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.