Acquisition Represents Important Addition to Company's Portfolio of Anthrax CountermeasuresROCKVILLE, Md., Mar 06, 2008 (BUSINESS WIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced that today it
completed the acquisition of a group of anthrax monoclonal antibodies
from AVANIR Pharmaceuticals (NASDAQ:AVNR), including AVANIR's lead
product candidate, AVP-21D9.
AVP-21D9 is a human monoclonal antibody product candidate that is
being developed as an intravenous treatment for patients who present
with symptoms of anthrax disease following exposure to Bacillus
anthracis. In non-clinical studies, this candidate demonstrated an
ability to protect animals challenged with a lethal dose of inhaled
anthrax spores. AVP-21D9 is being developed with funding support from
the National Institute of Allergy and Infectious Diseases of the
National Institutes of Health (NIAID), including a grant to establish
a cGMP manufacturing process and to test efficacy in additional
inhalation studies.
"The acquisition of AVANIR's monoclonal anthrax antibodies rounds
out our anthrax countermeasure program nicely. In addition to our
FDA-approved product, BioThrax(R) (Anthrax Vaccine Adsorbed), which is
indicated for pre-exposure prevention of anthrax in individuals at
high risk of exposure to anthrax spores, we are developing a
polyclonal anthrax immune globulin therapeutic, which is a human
plasma-derived product candidate. Now, as a result of this
acquisition, we have another anthrax therapeutic in our product
portfolio - a new monoclonal anthrax antibody product candidate that
has performed well in proof-of-concept studies," said Fuad El-Hibri,
chairman and chief executive officer of Emergent BioSolutions. "This
transaction reflects our ongoing commitment to develop a full
portfolio of countermeasures to strengthen our country's preparedness
in the event of future anthrax attacks."
The U.S. government is funding the development of, and seeking to
procure, two types of treatments for inhalational anthrax disease:
polyclonal antibody products, also known as immune globulins, and
monoclonal antibody products. Emergent BioSolutions currently is
developing a polyclonal anthrax immune globulin (AIG) product, which
is being manufactured by Talecris Biotherapeutics, Inc., at its
FDA-approved production facilities. Two full-scale lots of this
product candidate have been manufactured under current good
manufacturing practices at Talecris, and we plan to conduct pivotal
human and animal studies in 2008 and 2009, which could position us for
a procurement contract as early as next year. NIAID has provided us
grant funding of up to $13.4 million for a combination of initiatives
relating to our AIG product candidate, including non-clinical efficacy
studies and a human safety and pharmacokinetics study.
We intend to pursue additional NIAID development funding for both
of our anthrax therapeutic product candidates, and we believe that
both therapeutics would be eligible to be procured by the U.S.
Department of Health and Human Service for inclusion in the SNS prior
to receiving marketing approval, provided that they are deemed to be
licensable under Project BioShield.
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.
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statements, other than statements of historical fact, including
statements regarding our strategy, future operations, prospects, plans
and objectives of management, including clinical trial results and
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clinical utility of our products; our ongoing and planned development
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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
September 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.
SOURCE: Emergent BioSolutions Inc.
Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
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301-795-1847
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