Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has met
with the U.S. Food and Drug Administration (FDA) to review Emergent’s
regulatory strategy for the development of its recombinant anthrax (rPA)
vaccine. Emergent recently submitted to FDA, among other documents, its
rPA Development Plan in response to the Department of Health and Human
Services’ (HHS) amendment to its request for proposal (RFP) to develop
and deliver up to 25 million doses of an rPA vaccine for the Strategic
National Stockpile. In amending the RFP, HHS required that all bidders
deemed to be in the competitive range submit to FDA a comprehensive plan
outlining the regulatory strategy for their rPA vaccine. Emergent
completed that submission on May 12, 2009 ahead of the June 15, 2009
submission deadline.
"We are extremely pleased with the feedback that we received from FDA
regarding our regulatory strategy for the development of our rPA vaccine
candidate,” stated Daniel Abdun-Nabi, president of Emergent
BioSolutions. "This meeting reassured us of the appropriateness of the
regulatory strategy that we submitted to FDA and that we can proceed
without major modification. As a result of these discussions, Emergent
is positioned to advance to the next step in its contract negotiations
with HHS for the development and delivery of 25 million doses of an rPA
anthrax vaccine to the Strategic National Stockpile."
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, 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 our ability to
win a development award and procurement contract with the U.S.
government for our recombinant protective antigen anthrax vaccine
candidate; our plans to expand our manufacturing facilities and
capabilities; the rate and degree of market acceptance and clinical
utility of our products; our ongoing and planned development programs,
preclinical studies and clinical trials; the timing of and our ability
to obtain and maintain regulatory approvals for our product candidates;
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,
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.
