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Acquisition positions Emergent to offer the U.S. Government a
domestic source for an advanced anthrax vaccine candidate to meet
planned procurement of 25 million doses of rPA vaccine
ROCKVILLE, Md.--(BUSINESS WIRE)--May 5, 2008--Emergent
BioSolutions Inc. (NYSE: EBS) announced today that it has completed
the acquisition of all assets and rights related to a recombinant
protective antigen (rPA) anthrax vaccine product candidate and related
technology from VaxGen, Inc. Recent improvements to the rPA vaccine,
specifically related to stability, suggests that it is well positioned
to be a leading candidate for an award under a request for proposal
(RFP) recently issued by the U.S. Department of Health and Human
Services (HHS). The vaccine candidate has completed one Phase 2
clinical study. This RFP is designed to meet the government's stated
goal to procure 25 million doses of an rPA anthrax vaccine for the
Strategic National Stockpile (SNS). HHS has indicated that any awards
under this RFP are scheduled to be granted in late 2008.
The acquisition of this rPA vaccine candidate, and the pending
RFP, have no effect on Emergent's $448 million contract with HHS for
the delivery of 18.75 million doses of BioThrax(R) (Anthrax Vaccine
Adsorbed), the only FDA approved vaccine for the prevention of anthrax
disease, into the SNS. Emergent continues to manufacture and deliver
doses of BioThrax in accordance with this multi-year agreement.
The company intends to manufacture this new rPA anthrax vaccine,
as well as BioThrax, in its recently constructed, large-scale
manufacturing facility at its Lansing campus. The acquisition of the
rPA vaccine candidate further solidifies Emergent's well established
franchise of anthrax countermeasures, which now includes:
- BioThrax(R), the only FDA-approved vaccine to prevent the
infection of anthrax. Nearly 2.0 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 102, 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;
- AVP-21D9, a human monoclonal antibody product candidate being
developed as an intravenous treatment for patients who present
symptoms of anthrax disease; and
- AIG, a polyclonal anthrax immune globulin product candidate,
which is derived from human plasma from individuals who have
been vaccinated with BioThrax.
"As the manufacturer of the only FDA approved anthrax vaccine,
Emergent BioSolutions has a proven track record of delivering critical
biodefense countermeasures to the U.S. Government. Given HHS's stated
commitment to procure up to an additional 25 million doses of a
recombinant anthrax vaccine for the Strategic National Stockpile, we
felt this was the right opportunity for our company at the right
time," said Fuad El-Hibri, chairman and chief executive officer of
Emergent BioSolutions. "Additionally, we are pleased to provide the
U.S. Government with the important option to select an advanced rPA
anthrax vaccine candidate from a domestic manufacturer. As the
premiere domestic biodefense supplier, this was a natural fit for us,"
he continued.
Data reviewed to date relating to the rPA vaccine candidate
suggests that the steps taken to address a prior stability issue
affecting the vaccine position the product for continued development
toward regulatory approval and to be a leading candidate for the HHS
procurement contract of 25 million doses under the recently issued
RFP.
Under the terms of the asset acquisition, Emergent BioSolutions
paid VaxGen $2 million upon execution of the definitive agreement and
may be obligated to pay up to an additional $8 million in milestone
payments, plus specified percentages of future net sales.
About rPA 102
The vaccine candidate, rPA 102, 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 the U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID). rPA 102 has been the subject of two
research and development grants totaling approximately $100 million
from the National Institute for Allergy and Infectious Diseases
(NIAID). In 2004, HHS awarded VaxGen an $877 million contract for
delivery of 75 million doses of rPA 102. The contract was subsequently
terminated by HHS, based on its determination that VaxGen failed to
successfully cure the condition endangering performance and failed to
meet a milestone imposed by HHS that required VaxGen to initiate a
clinical trial of the vaccine candidate by December 18, 2006. This
failure was primarily related to stability issues with the vaccine.
About USAMRIID
USAMRIID, located at Fort Detrick, Maryland, is the lead medical
research laboratory for the DoD Biological Defense Research Program,
and plays a key role in national defense and in infectious disease
research. The Institute conducts basic and applied research on
biological threats resulting in medical solutions (such as vaccines,
drugs and diagnostics) to protect the warfighter. While USAMRIID's
primary mission is focused on the military, its research often has
applications that benefit society as a whole. USAMRIID is a
subordinate laboratory of the U.S. Army Medical Research and Materiel
Command. For more information, visit www.usamriid.army.mil.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a profitable, multinational
biopharmaceutical company dedicated to one simple mission -- to
protect life. We develop, manufacture and commercialize immunobiotics,
consisting of vaccines and therapeutics that assist the body's immune
system to prevent or treat disease. Our products target infectious
diseases and other medical conditions that have resulted in
significant unmet or underserved public health needs. Our 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. More information on the company is available 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 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 our ability to obtain new BioThrax(R) sales
contracts with the U.S. government; our plans for future sales of
BioThrax; our plans to pursue label expansions and improvements for
BioThrax; 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; our ability to identify and
acquire or in license products and product candidates that satisfy our
selection criteria; the potential benefits of our existing
collaboration agreements and our ability to enter into selective
additional collaboration arrangements; the timing of and our ability
to obtain and maintain regulatory approvals for our product
candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our intellectual property portfolio; our
estimates regarding expenses, future revenue, capital requirements and
needs for additional financing; and other factors identified in the
company's Annual Report on Form 10-K for the year ended December 31,
2007 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:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt, 301-795-1800
Director, Corporate Communications
SchmittT@ebsi.com
SOURCE: Emergent BioSolutions Inc.
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