BioCryst
Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has
completed its Type C meeting regarding intravenous (i.v.) peramivir
with the U.S. Food & Drug Administration (FDA) and has received final
meeting minutes. The minutes of the meeting were consistent with the
FDA’s preliminary comment letter, which was previously referenced in the Company’s
press release of April 1, 2013. In addition, the meeting minutes
confirmed that BioCryst’s proposed peramivir New Drug Application (NDA)
content supports a reviewable NDA submission for the indication of acute
uncomplicated influenza. In accordance with FDA’s recommendation, the
Company is in the process of requesting a pre-NDA meeting to reach
agreement on a complete NDA submission and to address review issues
identified in the minutes.
BioCryst anticipates that The Biomedical Advanced Research and
Development Authority (BARDA/HHS) will schedule and hold its In-Process
Review (IPR) meeting in the second quarter of this year with the
objective of determining the future for the underlying peramivir
development contract.
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 BARDA/HHS. 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 the FDA may require additional studies beyond the studies planned
for product candidates or may not provide regulatory clearances,
including for peramivir; 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 its programs 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.
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