Tuesday, January 26, 2010 9:28:11 AM
BIRMINGHAM, Ala., Jan 26, 2010 /PRNewswire via COMTEX/ -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that its partner, Shionogi
& Co., Ltd. will launch RAPIACTA, intravenous (i.v.) peramivir anti-viral, to
treat patients with influenza in Japan, on January 27, 2010. An English version
of Shionogi's press release announcing this launch is available on the web at:
http://www.shionogi.co.jp/ir_en/news/detail/e_100126.pdf
On January 13, 2010, Shionogi received the world's first marketing and
manufacturing approval for both single dose administration of 300 mg i.v.
peramivir for adult uncomplicated seasonal influenza infection, as well as
single and multiple dose administration of 600 mg i.v. peramivir for the
patients at high-risk for complications associated with influenza. Shionogi is
authorized to supply peramivir as either a 300 mg i.v. bag or a 150 mg vial for
i.v. drip infusion.
Recognizing that novel anti-viral influenza drugs are needed for the H1N1
pandemic, Shionogi has stated it intends to prepare an adequate supply for
approximately 700,000 people within its current fiscal year, which ends March
31, 2010, and it will also make efforts to ensure the manufacturing for stable
supply in its next fiscal year.
The National Health Insurance (NHI) price listing in Japan was established
January 22, 2010 as:
5,792 yen per RAPIACTA 300 mg bag
3,117 yen per RAPIACTA 150 mg vial
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 multiple influenza strains,
including pandemic H1N1 swine origin flu viral strains. Peramivir has been
studied in over 1800 patients with complicated and uncomplicated influenza.
Green Cross Corp. has filed for regulatory approval in Korea. On October 23,
2009, BioCryst announced that the U.S. Food and Drug Administration (FDA) issued
an emergency use authorization (EUA) for intravenous peramivir in certain adult
and pediatric patients with confirmed or suspected 2009 H1N1 influenza A
infection who are admitted to a hospital. Additional information regarding the
peramivir EUA is available on the web at: http://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. For more information, please visit the
Company's Web site at www.biocryst.com.
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