Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years

* Reuters is not responsible for the content in this press release.

Wed Jun 10, 2009 12:37pm EDT

* Emergent entitled to approximately $30 million from HHS for prior deliveries
to the Strategic National Stockpile; amount expected to be recognized as revenue
in 2Q 2009
* FDA approval triggers BioThrax price increase for future deliveries under HHS
procurement contracts
* HHS follow-on procurement contract for the delivery of 14.5 million doses now
based on an increased price per dose and valued at $405 million

ROCKVILLE, Md.--(Business Wire)--
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its flagship product,
BioThrax® (Anthrax Vaccine Adsorbed), has been granted a shelf life extension
from 3 to 4 years by the U.S. Food and Drug Administration (FDA). Based on this
approval, Emergent has achieved a contract milestone warranting a payment of
approximately $30 million for doses previously delivered to the Strategic
National Stockpile (SNS) under the terms of the company`s existing BioThrax
procurement contracts with the Department of Health and Human Services (HHS).
This amount is expected to be recognized as revenue in the second quarter of
2009. In addition, FDA approval of 4-year expiry dating results in an immediate
price increase for the future delivery of BioThrax doses under the current
contract as well as under the follow-on multi-year contract, valued at $405
million, for the delivery of 14.5 million doses of BioThrax. 

"We are pleased that the FDA has approved the 4-year expiry dating of BioThrax
as this extends the ability of the U.S. government to store our product in the
nation`s Strategic National Stockpile," said Fuad El-Hibri, chairman and chief
executive officer of Emergent BioSolutions. "This is a critically important
product feature that we believe will increase the attractiveness of BioThrax to
the U.S. government as it increases BioThrax`s lifecycle value. We are
continuing our efforts to further enhance the attributes of BioThrax, including
research towards a further reduction in the vaccination schedule and an expanded
label indication for post-exposure prophylaxis. We believe these enhancements,
if approved, will advance the U.S. government`s preparedness efforts in response
to anthrax as a potential weapon of bioterrorism." 

Emergent has been pursuing a number of BioThrax product enhancements over the
past several years. In addition to FDA approval of 4-year dating for BioThrax,
in December 2008, Emergent received FDA approval of a reduced vaccination
regimen to a five-dose schedule and a change to an intramuscular route of
administration. Emergent continues to research additional enhancements to
BioThrax such as a possible further reduction in the vaccination regimen and a
potential label expansion to include use as a post-exposure prophylaxis. 

To date, Emergent has supplied over 33 million doses of BioThrax to the U.S.
government, with additional deliveries to the SNS scheduled through the third
quarter of 2011. 

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
infection. It is indicated for the active immunization of adults who are at high
risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate,
made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S.
government has procured nearly 33.5 million doses of BioThrax. During that time
period, more than 8.7 million doses have been administered to more than 2.2
million military personnel. For full FDA-approved prescribing information,
please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf. 

Important Information About BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in
clinical studies were tenderness, pain, erythema and arm motion limitation. The
most common (>5%) systemic adverse reactions were muscle aches, fatigue and
headache. Serious allergic reactions, including anaphylactic shock, have been
observed during post-marketing surveillance in individuals receiving BioThrax. 

Pregnant women should not be vaccinated unless the potential benefits of
vaccination have been determined to outweigh the potential risk to the fetus. If
BioThrax is used during pregnancy, or if the patient becomes pregnant during the
immunization series, the patient should be apprised of the potential hazard to
the fetus. This product should be administered with caution to persons with a
possible history of latex sensitivity since the vial stopper contains dry
natural rubber. 

Vaccination with BioThrax should be avoided by individuals with a history of
anaphylactic or anaphylactic-like reaction following a previous dose of
BioThrax. 

BioThrax is not licensed for use in a post-exposure setting. The safety and
efficacy of BioThrax have not been established in pregnant women, nursing
mothers, pediatric populations or geriatric populations. 

BioThrax may not protect all individuals vaccinated, particularly patients with
impaired immune responses due to congenital or acquired immunodeficiency, or
immunosuppressive therapy. Individuals are not considered protected until they
have completed the full vaccination series. 

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 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; our ongoing and planned development programs, preclinical studies
and clinical trials; 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. 

BioThrax is a registered trademark of Emergent Biodefense Operations Lansing
Inc. 





Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com



Copyright Business Wire 2009

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