21.03.2007 11:00:00
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Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
submitted an Investigational New Drug (IND) application with the U.S.
Food and Drug Administration (FDA) for the company’s
Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic
treatment for patients who present with symptoms of anthrax disease
resulting from the release of anthrax toxins into the body. Pending the
standard 30-day FDA review period, the company expects to initiate a
pivotal clinical trial in 2007 in order to evaluate AIG safety and
pharmacokinetics in 105 healthy volunteers.
"The filing of this IND for our AIG product
candidate is a significant step as we continue to expand our anthrax
biodefense product franchise, which includes BioThrax®
(Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against
anthrax infection, as well as development programs focused on
improvements to BioThrax and an enhanced anthrax vaccine,”
stated Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions. "Our AIG product, which we are
developing in part with grant funding from the NIAID, is an important
element of our efforts to develop safe and effective medical
countermeasures to help protect the nation against biological attack.”
The company anticipates that the clinical trial for its AIG candidate
will be completed within approximately one year from its commencement
date and that no additional clinical trials will be required prior to
submitting an application to FDA for marketing approval. The company,
which is relying on the FDA animal rule in developing its AIG candidate,
expects to conduct pivotal efficacy studies in two animal models, with
the timing of those studies dependent upon completion of the development
of the models in collaboration with the U.S. government. The company
believes that favorable data from these clinical and non-clinical
studies would be sufficient to support an application to the FDA for
approval of its AIG candidate.
During 2006, the National Institute of Allergy and Infectious Diseases
(NIAID) agreed to provide funding to the company of up to $3.7 million
to support pivotal animal studies and for the development and validation
of product assays.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of immunobiotics,
consisting of vaccines and therapeutics that induce or assist the body’s
immune system to prevent or treat disease. The company’s
biodefense business is focused on immunobiotics for use against
biological agents that are potential weapons of bioterrorism. The company’s
commercial business is focused on development, manufacture and
commercialization of immunobiotics for use against infectious diseases.
These immunobiotics are designed to address 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, our strategy,
future operations, future financial position, future revenues, projected
costs, prospects, plans and objectives of management 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 performance under existing
BioThrax® sales
contracts with the U.S. government, including the timing of deliveries
under these contracts; our ability to obtain new BioThrax sales
contracts with the U.S. government; our plans for future sales of
BioThrax; 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; 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
Registration Statement on Form S-1 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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