BIRMINGHAM, Ala., Nov. 5 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals,
Inc. (Nasdaq: BCRX) today announced it has received an initial order for
10,000 courses of intravenous (i.v.) peramivir (600 mg once-daily for five
days) with a value of $22.5 million under a newly issued contract with the
Department of Health and Human Services (HHS). On November 4, BioCryst
shipped the entire order from existing i.v. peramivir inventory to HHS.
"BioCryst is pleased to deliver this initial U.S. Government order for
peramivir for use under the Emergency Use Authorization, or EUA, to treat
hospitalized adult and pediatric influenza patients who may benefit from
peramivir," said Jon P. Stonehouse, President and Chief Executive Officer at
BioCryst. "We expect to complete production of approximately 120,000
additional courses of i.v. peramivir by the end of December, and we are
prepared to produce more if required to meet orders for the U.S. or other
governments. BioCryst has been in contact with a number of governments around
the world that are assessing i.v. peramivir for critically ill influenza
patients."
Under the Indefinite Delivery Indefinite Quantity contract issued to BioCryst
on November 3, 2009, HHS may place additional orders for peramivir up to a
total of 40,000 courses of i.v. peramivir at the same unit price as the first
order. BioCryst is also required to maintain the ability to manufacture
additional treatment courses dependent on the volume and size of anti-viral
orders received from HHS.
About peramivir
Peramivir is a potent, intravenously administered 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 pandemic H1N1
swine flu origin viral strains. Peramivir has been studied in over 1,800
patients with complicated and uncomplicated influenza. On October 23, 2009,
BioCryst announced that the U.S. Food and Drug Administration (FDA) issued an
emergency use authorization (EUA) for i.v. peramivir in certain adult and
pediatric patients with confirmed or suspected 2009 H1N1 influenza infection
who are admitted to a hospital. Additional information regarding the
peramivir EUA is available on the web at: www.cdc.gov/h1n1flu/eua/.
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
additional orders for peramivir and such orders, 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 BioCryst or its
licensees may not commence as expected additional human clinical trials with
our product candidates; 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.
Robert Bennett of BioCryst Pharmaceuticals, +1-919-859-7910
