RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it received
a preliminary comment letter from the U.S. Food & Drug Administration
(FDA) that outlines a pathway by which BioCryst could file a New Drug
Application (NDA) seeking regulatory approval of intravenous (i.v.) peramivir.
The letter was sent in response to questions BioCryst submitted to the
FDA in advance of an upcoming Type C regulatory meeting regarding i.v.
peramivir. The FDA also suggested the Company request a pre-NDA meeting
to reach agreement on a complete NDA submission and to address review
issues identified in its preliminary comment letter.
BioCryst also received written notification from the Department of
Health and Human Services in the form of a Stop-Work Order directing the
Company to cease work on peramivir under its U.S. Government contract,
except for certain activities primarily related to the upcoming FDA Type
C meeting which is scheduled. The notification confirmed that the
Biomedical Advanced Research and Development Authority (BARDA/HHS) will
continue to support and fund certain activities that are necessary to
achieve immediate milestones, as well as activities deemed essential to
maintain compliance with FDA regulations or to fulfill pending FDA
requests. Following an In-Process Review (IPR) meeting, which BioCryst
anticipates in the second quarter, BARDA/HHS is expected to determine
the path forward for the contract.
"We are encouraged by these recent communications, and we look forward
to advancing our peramivir discussions with the FDA and BARDA/HHS. Our
ultimate objective is the approval of peramivir as an intravenous
treatment option that could benefit patients in the United States," said Jon
P. Stonehouse, President & Chief Executive Officer. "The
Stop—Work Order is understandable, as it focuses the scope of
reimbursable activities to those that are essential and supportive to
continuing regulatory communications, with the objective of preparing an
NDA submission. If the conversations with the FDA and BARDA/HHS are
successful, BioCryst stands ready to file an NDA for peramivir as soon
as feasible."
About Influenza
The influenza virus causes an acute viral disease of the respiratory
tract. Unlike the common cold and some other respiratory infections,
seasonal flu can cause severe illness, resulting in life-threatening
complications. According to the CDC, an estimated 5% to 20% of the
American population suffers from influenza annually, and there are
approximately 3,000 to 49,000 flu-related deaths per year in the U.S.
Most at risk are young children, the elderly and people with seriously
compromised immune systems.
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
pandemic H1N1 swine flu viral strains. Peramivir is being developed
under a $234.8 million contract from HHS/BARDA. In January 2010,
Shionogi & Co., Ltd. launched intravenous (i.v.) 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 BioCryst or its licensees may not be able to enroll the required
number of subjects in planned clinical trials of its product candidates
and that such clinical trials may not be successfully completed; that
the Company or its licensees may not commence as expected additional
human clinical trials with product candidates; that the FDA may require
additional studies beyond the studies planned for product candidates or
may not provide regulatory clearances, especially associated with the
peramivir program, which may result in delay of planned clinical trials,
may impose a clinical hold with respect to such product candidate, or
may withhold market approval for product candidates; that BARDA/HHS may
further condition, reduce or eliminate future funding of the peramivir
program; that BioCryst may never file an NDA for peramivir approval and
peramivir may never be approved for any use by the FDA; that ongoing and
future preclinical and clinical development may not have positive
results; that the Company or its licensees may not be able to continue
future development of current and future development programs; that such
development programs may never result in future product, license or
royalty payments being received; and 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, Inc.
Robert Bennett, +1-919-859-7910
Source: BioCryst Pharmaceuticals, Inc.
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