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The company's submission provides the U.S. Government with the
critical option to select a domestic source to meet planned
procurement of 25 million doses of rPA vaccine
ROCKVILLE, Md.--(BUSINESS WIRE)--July 31, 2008--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that it has submitted a
proposal in response to a request for proposal (RFP) issued by the
U.S. Department of Health and Human Services (HHS) for a recombinant
protective antigen anthrax vaccine (rPA). Emergent's rPA vaccine
candidate is a reformulated and more stable form of the rPA 102
vaccine originally developed at the U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) and is well-positioned to
be a leading candidate for an award under this RFP. One Phase II
clinical trial of rPA 102 has been completed.
HHS's 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). In the event that Emergent receives an award
under the rPA RFP, doses of rPA procured by HHS would be in addition
to the 18.75 million doses of the company's FDA-licensed product,
BioThrax(R) (Anthrax Vaccine Adsorbed), that HHS is procuring under
the existing $448M contract with Emergent. HHS has indicated that any
awards under the rPA RFP would be granted at the end of 2008, at the
earliest.
"We are very pleased with our submission in response to this RFP,
and we are confident that our rPA 102 vaccine is a leading candidate
to be selected as an advanced rPA anthrax vaccine. Our company is
proud of our proven track record of delivering critical biodefense
countermeasures to the U.S. government, and we believe our reputation
as the premiere domestic biodefense supplier, coupled with our
development and manufacturing expertise, uniquely situates Emergent to
meet HHS's stated commitment to procure 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.
"Considerable resources have been devoted to improving the
stability of the rPA 102 vaccine. Analytical testing and non-clinical
data indicate the changes made to the formulation of rPA 102 has
significantly improved the stability of this vaccine candidate. We are
confident that the formulation changes have addressed previous
concerns regarding the stability of the product. We believe that the
current formulation will meet the U.S. government's stability
requirements for an rPA vaccine," said Dr. James Jackson, senior vice
president and chief scientific officer of Emergent BioSolutions.
The company expects to manufacture this rPA anthrax vaccine, as
well as BioThrax, in its recently constructed, large-scale
manufacturing facility at its Lansing campus. The continued
development of this rPA vaccine candidate further solidifies
Emergent's franchise of anthrax countermeasures, which now includes:
BioThrax - 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;
AVA7909 - 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).;
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 immune globulin product candidate being
developed as an intravenous post-exposure treatment for patients who
present symptoms of anthrax disease, is derived from human plasma from
individuals who have been vaccinated with BioThrax.
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 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).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading, multinational
biopharmaceutical company dedicated to one simple mission -- to
protect life. Emergent develops, manufactures and commercializes
immunobiotics, consisting of vaccines and therapeutics that assist the
body's immune system to prevent or treat disease. Emergent's products
target infectious diseases and other medical conditions that have
resulted in significant unmet or underserved public health needs. The
company'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. 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 sales contracts for
BioThrax(R), rPA 102, AVA7909, AVP-21D9 and AIG with the U.S.
government; our plans for future sales of BioThrax, rPA 102, AVA7909,
AVP-21D9 and AIG; 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; 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 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:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
SOURCE: Emergent BioSolutions Inc.
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