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ROCKVILLE, Md.--(BUSINESS WIRE)--Sept. 12, 2008--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that the Department of
Health and Human Services (HHS) has informed the company that its
proposal to provide a recombinant protective antigen anthrax vaccine
(rPA) is technically acceptable and within the competitive range.
Emergent's proposal was in response to HHS's request for proposal
(RFP) for development and delivery of 25 million doses of an rPA
anthrax vaccine for the Strategic National Stockpile. As a next step,
Emergent will begin to provide additional technical and business
information in connection with the ongoing negotiation process.
Companies notified that they are within the competitive range are
those that have submitted proposals that have a reasonable chance of
being selected for an award based on the factors specified in HHS's
RFP. HHS has indicated that any awards under the rPA RFP would be
granted at the end of 2008, at the earliest.
"We are pleased that Emergent's rPA vaccine candidate has advanced
to this next stage and is being considered by HHS to address the
government's goal of procuring 25 million doses of a recombinant
anthrax vaccine for the Strategic National Stockpile," said Fuad
El-Hibri, chairman and chief executive officer of Emergent
BioSolutions. "We believe our rPA anthrax vaccine candidate can be
successfully developed and, together with BioThrax, our FDA licensed
vaccine for the prevention of anthrax, can become an important
component of our nation's stockpile of medical countermeasures."
The company expects to manufacture its rPA anthrax vaccine, as
well as BioThrax, in its recently constructed, large-scale
manufacturing facility at its Lansing, Michigan campus. The continued
development of this rPA vaccine candidate further solidifies
Emergent's franchise of anthrax countermeasures, which now includes:
ANTHRAX VACCINES
- BioThrax(R) - the only FDA-approved vaccine to prevent the
infection of anthrax. Over two million men and women of the
United States military have received the vaccine, and HHS has
procured more than 28 million doses of BioThrax for the SNS;
- rPA - a recombinant anthrax vaccine candidate, which is
composed of a purified protein with an alum adjuvant and is
designed to induce antibodies that neutralize anthrax toxins;
and
- AV7909 - an anthrax vaccine candidate composed of BioThrax(R)
and the immunostimulatory oligodeoxynucleotide compound CPG
7909 (VaxImmune(R)) developed by Coley Pharmaceutical Group
(purchased by Pfizer Inc. in 2007).
ANTHRAX THERAPEUTICS
- AVP-21D9 - a human monoclonal antibody product candidate being
developed as an intravenous post-exposure treatment for
patients who present symptoms of anthrax disease; and
- AIG - a polyclonal anthrax immunoglobulin product candidate
being developed as an intravenous post-exposure treatment for
patients presenting symptoms of anthrax disease, is derived
from human plasma from individuals who have been vaccinated
with BioThrax.
About Emergent's Anthrax rPA vaccine candidate
The vaccine candidate, rPA, is based on a recombinant form of the
protective antigen protein. This vaccine contains a purified protein
(rPA) formulated with an alum adjuvant and is designed to induce
antibodies that neutralize anthrax toxins. The vaccine candidate does
not cause anthrax infection and is based on the pioneering work of
USAMRIID. Emergent's rPA has been the subject of two research and
development grants totaling approximately $100 million from the
National Institute for Allergy and Infectious Diseases (NIAID).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company
dedicated to one simple mission--to protect life. Emergent develops,
manufactures and commercializes immune-related biologics, vaccines and
biotherapeutics that assist the body's immune system to prevent or
treat infectious and other life threatening diseases. Emergent's
marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only
vaccine approved by the U.S. Food and Drug Administration for the
prevention of anthrax infection. Emergent's clinical pipeline includes
programs focused on anthrax, botulism, typhoid, tuberculosis,
hepatitis B and chlamydia. 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 our expected revenue growth and
net earnings for 2008, 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 for
them, and other factors identified in the company's current report on
Form 10-Q for the quarter ended June 30, 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.
CONTACT: Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Kimberly B. Root
Director, Public Affairs
517-327-1543
RootK@ebsi.com
SOURCE: Emergent BioSolutions Inc.
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