RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company
focused on the development and commercialization of treatments for rare
and infectious diseases, today announced that it has submitted a New
Drug Application (NDA) filing for intravenous (i.v.) peramivir
to the U.S. Food & Drug Administration (FDA). BioCryst is seeking an
indication as the first i.v. neuraminidase inhibitor approved in the
U.S. for the treatment of acute uncomplicated influenza in adults.
Peramivir is approved in Japan and Korea for the treatment of influenza.
In June 2013, BioCryst completed a pre-NDA meeting with the FDA
regarding peramivir. BioCryst reached agreement with FDA regarding all
requirements for a complete NDA submission. The peramivir NDA submission
includes results in over 2700 subjects treated with peramivir in 27
clinical trials.
"BioCryst's first NDA filing represents an important milestone in the
history of the company. We are excited about the potential approval of
peramivir as an i.v. treatment option that could benefit influenza
patients in the United States," said Jon
P. Stonehouse, President & Chief Executive Officer. "BioCryst is
preparing to make peramivir available in the U.S. in time for the
2014-15 influenza season, in the event approval is received in that
timeframe. We thank BARDA/HHS for enabling the successful completion of
this program."
BioCryst requested and was granted a small business waiver of the
application fee for the peramivir NDA filing. The waiver confirmation
was submitted with the NDA filing.
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 has been 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 rare
diseases, with the goal of addressing unmet medical needs of patients
and physicians. BioCryst's core development programs include BCX4161 and
two next generation oral inhibitors of plasma kallikrein for hereditary
angioedema; peramivir,
a viral neuraminidase inhibitor for the treatment of influenza; 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 the Company may not be able to access adequate capital to
move peramivir forward; that the Company may not reach favorable
agreements with potential pharmaceutical and biotechnology partners for
the commercialization of peramivir. 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.
News Provided by Acquire Media