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Emergency Use Authorization Granted For BioCryst's Peramivir
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BIRMINGHAM, Ala., Oct. 23 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals,
Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration
(FDA), in response to a request from the U.S. Centers for Disease Control and
Prevention (CDC), has issued an emergency use authorization (EUA) for the
investigational anti-viral drug intravenous (i.v.) peramivir in certain adult
and pediatric patients with confirmed or suspected 2009 H1N1 influenza
infection who are admitted to a hospital.
Specifically, i.v. peramivir is authorized only for hospitalized adult and
pediatric patients for whom therapy with an i.v. drug is clinically
appropriate, based on one or more of the following reasons:
1. the patient is not responding to either oral or inhaled anti-viral
therapy, or
2. when drug delivery by a route other than an intravenous route -- e.g.,
enteral (absorbed by the intestines) or inhaled -- is not expected to
be
dependable or feasible;
3. for adults only, when the clinician judges i.v. therapy is appropriate
due to other circumstances.
Additional information regarding the peramivir EUA is available on the Web at:
www.cdc.gov/h1n1/eua
In advance of any U.S. Government order that may come from the ongoing request
for proposal (RFP) negotiations, BioCryst has donated and transferred to the
Department of Health and Human Services (HHS) an initial supply sufficient for
1,200 courses of i.v. peramivir 600 mg once-daily for five days. This transfer
was made under the development contract with HHS to allow doctors and patients
near-term access to the drug, and is separate from the RFP process.
"The issuance of this EUA is important because it makes peramivir a treatment
option for physicians in the U.S. during the ongoing influenza health
emergency," said Jon P. Stonehouse, Chief Executive Officer at BioCryst.
"BioCryst has worked with HHS to enable the Government to rapidly deploy an
initial supply of peramivir, and we are prepared to deliver more."
To prepare for peramivir orders that BioCryst may receive from the U.S. or
other governments during this pandemic emergency, BioCryst is completing
production of approximately 130,000 courses of i.v. peramivir and is prepared
to make more, if required.
About Peramivir
Peramivir is an anti-viral agent that was discovered by BioCryst which
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 pandemic H1N1 swine flu origin viral
strains. Peramivir has been studied in patients with complicated and
uncomplicated influenza. BioCryst's partner, Shionogi & Co., Ltd. is currently
preparing to file for regulatory approval in Japan this year.
About BioCryst
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule
pharmaceuticals that block key enzymes involved in infectious diseases, cancer
and inflammatory diseases. BioCryst has progressed two novel compounds into
late-stage pivotal clinical trials; peramivir, an anti-viral for influenza,
and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for
cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and
structure-based drug design, BioCryst continues to discover additional
compounds and to progress others through pre-clinical and early development to
address the unmet medical needs of patients and physicians. The Company's
strategic alliances with the U.S. Department of Health and Human Services,
Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International
Holdings Limited validate its scientific foundation and the utility of its
product candidates. For more information, please visit the Company's Web site
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 our 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 U.S. government and ex-U.S. governments may choose not to issue a
request for peramivir to treat influenza or such requests, if any, may not
result in an order or such order, if any, may not be profitable for BioCryst;
that to the extent peramivir is used as a treatment for H1N1 flu (or other
strains of flu), there can be no assurance that it will prove effective; that
HHS may further condition, reduce or eliminate future funding of the peramivir
program; that ongoing peramivir clinical trials or our peramivir program in
general may not be successful; that our product candidates may not receive
required regulatory clearances from the FDA; that ongoing and future
pre-clinical and clinical development may not have positive results; that we
or our licensees may not be able to continue future development of our current
and future development programs; that our development programs and
partnerships may never result in future product, license or royalty payments
being received by BioCryst; that BioCryst may not be able to retain its
current pharmaceutical and biotechnology partners for further development of
its product candidates or it may not reach favorable agreements with potential
pharmaceutical and biotechnology partners for further development of its
product candidates; that our actual cash burn rate may not be consistent with
our expectations; that BioCryst may not have sufficient cash to continue
funding the development, manufacturing, marketing or distribution of its
products and that additional funding, if necessary, may not be available at
all or on terms acceptable to BioCryst. 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, most recent Registration
Statement on Form S-3 (filed November 28, 2008), 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 our projections and forward-looking statements.
BCRXW
SOURCE BioCryst Pharmaceuticals, Inc.
Investors: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910; or
Media: Catherine Collier Kyroulis, Burns McClellan, +1-212-213-0006
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