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BioCryst Pharmaceuticals Completes Peramivir Type C Meeting



  BioCryst Pharmaceuticals Completes Peramivir Type C Meeting

Business Wire

RESEARCH TRIANGLE PARK, N.C. -- April 16, 2013

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.

BCRXW

Contact:

BioCryst Pharmaceuticals, Inc.
Robert Bennett, 919-859-7910
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