Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
submitted to the U.S. Food and Drug Administration (FDA) a Development
Plan for the company’s Recombinant Protective Antigen (rPA) anthrax
vaccine candidate. Emergent submitted the Development Plan ahead of the
June 15 deadline in response to the Department of Health and Human
Services’ (HHS) amendment to its request for proposal to develop and
deliver up to 25 million doses of an rPA vaccine for the Strategic
National Stockpile. The amendment requested that all bidders deemed to
be in the competitive range submit to FDA a comprehensive plan outlining
the regulatory strategy for their rPA vaccine.
"We are pleased to successfully meet this HHS requirement ahead of
schedule and look forward to receiving comments and guidance from the
FDA,” said Daniel J. Abdun-Nabi, president and chief operating officer
of Emergent BioSolutions. "As the premier supplier of medical
countermeasures to the U.S. government, we are fully committed to moving
our rPA program forward and remain optimistic of our competitiveness to
receive any award granted by HHS to develop and supply the Strategic
National Stockpile with an rPA vaccine.”
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.
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, 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 the timing
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 current report on Form 10-Q for the period ended March 31,
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.
