Emergent BioSolutions Inc. (ticker: EBS, exchange: New York Stock Exchange (.N))
News Release -
17-Sep-2010
Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6
Million to Develop rPA Anthrax VaccineROCKVILLE, Md., Sep 17, 2010 (BUSINESS WIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed
a contract, valued at up to $186.6 million, with the Biomedical Advanced
Research and Development Authority (BARDA) of the Department of Health
and Human Services (HHS), for the development of a recombinant
protective antigen (rPA) anthrax vaccine. This five year cost plus fixed
fee development contract consists of a two-year base period of
performance valued at approximately $51 million, three successive
one-year option periods valued at approximately $126 million and funding
for optional non-clinical studies valued at approximately $9 million.
"We applaud the U.S. Government's commitment to the biodefense industry
and to the development of additional medical countermeasures using
multiple technologies and additional sites to address the acknowledged
anthrax threat," said Fuad El-Hibri, chairman and chief executive
officer of Emergent BioSolutions. "This award solidifies Emergent's
anthrax franchise and reaffirms our position as a leading supplier to,
and developer for, the U.S. government of anthrax biomedical
countermeasures. We are enthusiastic about the role we serve in
addressing this need and in creating jobs and expanding economies within
the local communities where we operate."
Under the contract, the base value will fund activities related to
process characterization and assay validation, as well as formulation
and stability studies. Milestone-based options include completion of a
Phase II clinical study and non-clinical efficacy studies, process
validation, as well as consistency lot manufacture. Emergent has
developed this comprehensive plan as a foundation to advance its rPA
anthrax vaccine candidate in preparation for pivotal studies that would
potentially lead to licensure application with the U.S. Food and Drug
Administration.
The company anticipates recognizing revenues from this award in the
fourth quarter of 2010 of approximately $2 million with no major impact
on pretax earnings.
Emergent's rPA anthrax vaccine candidate is a purified recombinant
protective antigen protein formulated with an alum adjuvant and is
designed to induce antibodies that neutralize anthrax toxins. It is
based on the pioneering work of the U.S. Army Medical Research Institute
of Infectious Diseases (USAMRIID) and has been the subject of two
research and development grants totaling approximately $100 million by
the National Institute of Allergy and Infectious Diseases (NIAID).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and antibody
therapies that assist the body's immune system to prevent or treat
disease. Emergent'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. Emergent's
product pipeline targets infectious diseases and includes programs
focused on anthrax, tuberculosis, typhoid, flu 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 2010, 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
win a procurement contract with the U.S. government for our recombinant
protective antigen anthrax vaccine candidate; our plans to expand our
manufacturing facilities and capabilities; the rate and degree of market
acceptance and clinical utility of our products; the success of 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 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, 2010 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 Media Contact: Tracey Schmitt Vice President, Corporate Communications 301-795-1800 SchmittT@ebsi.com |