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ROCKVILLE, Md., May 17, 2010 (BUSINESS WIRE) --Emergent BioSolutions Inc. (NYSE:EBS) announced today that its
Investigational New Drug (IND) application, to commence a Phase I
clinical trial for its anthrax monoclonal antibody therapeutic, has
cleared U.S. Food and Drug Administration (FDA) review. The Phase I
study will evaluate the safety and pharmacokinetics of the company's
fully human monoclonal antibody being developed as a parenteral
post-exposure therapy for individuals who have symptoms of anthrax
disease. In pre-clinical therapeutic studies, Emergent's monoclonal
antibody was found to be effective.
"Emergent is committed to advancing its anthrax franchise, which
includes both vaccines and therapeutics that address the anthrax
threat," said Stephen Lockhart, MRCP, senior vice president product
development of Emergent BioSolutions. "The end goal is to strengthen the
nation's arsenal of medical countermeasures and provide products that
will support the government's biopreparedness efforts."
The Phase I clinical trial is designed as a randomized, double-blind,
placebo-controlled, dose-escalation study involving 50 healthy
volunteers. Emergent anticipates the overall duration of the trial to be
15 months, with dosing of all subjects expected to be completed within
11 months of initiation of the clinical trial.
Emergent has received $24.3 million in development funding from the
United States Government to support the development of its monoclonal
antibody as a therapeutic for inhalation anthrax. This study is being
funded by the Biomedical Advance Research and Development Authority
(BARDA) and the National Institute of Allergy and Infectious Diseases
(NIAID), National Institutes of Health (NIH), Department of Health and
Human Services (HHS), under contract No. HHSN272200800040C.
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 the success of
our ongoing and planned preclinical studies and clinical trials; the
rate and degree of market acceptance and clinical utility of our
products; the success of our ongoing and planned development programs;
the timing of and our ability to obtain and maintain regulatory
approvals for our other product candidates; our commercialization,
marketing and manufacturing capabilities and strategy; 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, 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 |