27.09.2007 17:00:00
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Emergent BioSolutions Receives Development Contract from NIAID/BARDA to Fund Continued Development of Anthrax Therapeutic
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
received a development contract, valued at up to $9.5 million, in
support of non-clinical and clinical studies of the company’s
anthrax therapeutic, or AIG, product candidate. This product candidate
is an immune globulin being developed as an intravenous therapeutic for
treatment of patients who present with symptoms of anthrax disease
following exposure to anthrax.
This development contract has been funded in whole or in part from
Federal funds from the National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH) and the Biomedical
Advanced Research and Development Authority (BARDA), Department of
Health and Human Services (HHS), under Contract No. HHSN272200700034C.
Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions, stated, "We are very pleased to
have continuing support for AIG from NIAID and BARDA and commend the
leadership throughout HHS for their commitment to funding the
development of effective medical countermeasures against this deadly
biological agent. With the continued development funding of our AIG
candidate, in conjunction with the $448 million contract with HHS
announced yesterday regarding procurement of 18.75 million doses of our
BioThrax anthrax vaccine for the strategic national stockpile, we are
very encouraged by the government’s support of
our anthrax franchise. We look forward to continuing to be a leading
participant in the U.S. government’s effort to
build a robust domestic biodefense industry.”
Under terms of the development award, the funds will be used to conduct
various studies on AIG, including (i) non-clinical studies in support of
efficacy; and (ii) a Phase I/II clinical study to evaluate
pharmacokinetics and safety. Previously, in August 2006 the company
received $3.9 million from NIAID in support of the company’s
AIG program. When combined with the $9.5 million under this new
development award, the total amount of government funding for AIG to
date is over $13 million.
About Anthrax Immune Globulin (AIG)
Emergent BioSolutions’ anthrax immune globulin
(AIG) is being developed as an intravenous therapeutic for treatment of
patients who present with symptoms of anthrax disease resulting from the
release of anthrax toxins into the body and for whom the use of the
vaccine is no longer an effective option. If successfully developed, AIG
could be prescribed for administration in these circumstances either as
a monotherapy or in conjunction with an antibiotic.
AIG is being developed using plasma collected from healthy donors who
have been vaccinated with BioThrax® (Anthrax
Vaccine Adsorbed), Emergent BioSolutions’
anthrax vaccine, which is the only vaccine approved by the U.S. Food and
Drug Administration for the prevention of anthrax infection.
The company has collected a sufficient amount of plasma to initiate
manufacturing of AIG under cGMP using a validated and approved process.
This manufacturing process entails fractionating the plasma and
purifying the immune globulin. The company has signed an exclusive
license with Talecris Biotherapeutics, Inc., a North Carolina-based
biopharmaceutical company and leading fractionation provider, to
fractionate, purify and fill AIG at Talecris’
FDA-approved facilities. To date, the first full-scale lot of AIG has
been manufactured under cGMP requirements at Talecris. The company has
scheduled plans to complete a second full-scale lot of AIG.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a 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 biodefense business
focuses on immunobiotics for use against biological agents that are
potential weapons of bioterrorism and biowarfare. Our marketed product,
BioThrax® (Anthrax Vaccine Adsorbed), is the
only vaccine approved by the U.S. Food and Drug Administration for the
prevention of anthrax infection. Our commercial business focuses on
immunobiotics for use against infectious diseases and other medical
conditions that have resulted in significant unmet or underserved public
health needs. 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 performance under our contract
with HHS and future payments from HHS to us under the contract, 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 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 Quarterly Report on Form 10-Q for the
quarter ended June 30, 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.
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