RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the
Biomedical Advanced Research and Development Authority (BARDA/HHS) has
released funding under the current $234.8 million contract to enable
completion of a New Drug Application (NDA) filing for intravenous (i.v.) peramivir.
BioCryst is seeking an indication for the treatment of acute
uncomplicated influenza and expects to submit the peramivir NDA by the
end of 2013.
On June 28, BioCryst completed a pre-NDA meeting with the FDA regarding
peramivir. BioCryst reached agreement with FDA regarding all
requirements for a complete NDA submission.
"We thank BARDA/HHS for its continued support of this program. This
remaining funding is what we need to get peramivir to the finish line,"
said Jon
P. Stonehouse, President & Chief Executive Officer. "We are
excited about the potential approval of peramivir as an i.v. treatment
option that could benefit influenza patients in the United States."
About Peramivir
Peramivir is a potent, intravenously administered investigational
anti-viral agent that rapidly delivers high plasma concentrations to the
sites of infection. Discovered by BioCryst, peramivir inhibits the
interactions of influenza neuraminidase, an enzyme which is critical to
the spread of influenza within a host. In laboratory tests, peramivir
has shown activity against multiple influenza strains, including H7N9
and pandemic H1N1 swine flu viral strains. Peramivir is being developed
under a $234.8 million contract from BARDA/HHS. In January 2010,
Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the
name RAPIACTA® to treat patients with influenza and in August 2010,
Green Cross Corporation announced that it had received marketing and
manufacturing authorization for i.v. peramivir in Korea to treat
patients with influenza A & B viruses, including H1N1 and avian
influenza. For more information about peramivir please visit BioCryst's
Web site at http://www.biocryst.com/peramivir.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small
molecule drugs that block key enzymes involved in infectious and
inflammatory diseases, with the goal of addressing unmet medical needs
of patients and physicians. BioCryst currently has two late-stage
development programs: peramivir, a viral neuraminidase inhibitor for the
treatment of influenza, and ulodesine,
a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of
gout. In addition, BioCryst has several early-stage programs: BCX4161
and a next generation oral inhibitor of plasma kallikrein for hereditary
angioedema and BCX4430,
a broad spectrum antiviral for hemorrhagic fevers. For more information,
please visit the Company's website at www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause BioCryst's actual results, performance or
achievements to be materially different from any future results,
performances or achievements expressed or implied by the forward-looking
statements. These statements reflect our current views with respect to
future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Some of the factors that
could affect the forward-looking statements contained herein include:
that the FDA may not provide regulatory approval for any use of
peramivir or that the approval may be limited; that BARDA/HHS may
further condition, reduce or eliminate future funding of the peramivir
program; that BioCryst may never file an NDA for peramivir regulatory
approval in any country; that the Company may not be able to access
adequate capital to move peramivir forward; that the Company may not be
able to retain its current pharmaceutical and biotechnology partners for
further development of its product candidates or may not reach favorable
agreements with potential pharmaceutical and biotechnology partners for
further development of product candidates. Please refer to the documents
BioCryst files periodically with the Securities and Exchange Commission,
specifically BioCryst's most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, and current reports on Form 8-K, all of
which identify important factors that could cause the actual results to
differ materially from those contained in BioCryst's projections and
forward-looking statements.
BCRXW
BioCryst Pharmaceuticals
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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