BioCryst's Partner Green Cross Receives Marketing & Manufacturing Approval for Peramivir in South Korea
BIRMINGHAM, Ala., Aug 16, 2010 (BUSINESS WIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) today announced that its partner, Green Cross Corporation has received marketing and manufacturing approval from KFDA (Korean Food & Drug Administration) for intravenous (i.v.) peramivir to treat patients with influenza A & B viruses, including pandemic H1N1 and avian influenza. Green Cross Corp. intends to launch peramivir under the commercial name PeramiFlu(R) in South Korea.
"We congratulate Green Cross on this achievement," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst. "We are pleased that intravenous peramivir is now approved in Korea and represents the second country this year to make this important treatment option available for patients suffering from seasonal influenza. BioCryst continues to focus on completing the U.S. development of i.v. peramivir as a potential treatment for hospitalized patients with seasonal influenza."
Green Cross Corp. received the indication of single dose administration of 300 mg i.v. peramivir for treatment of adults with influenza A & B infection. In November 2009 after review through the Central Pharmaceutical Affairs Council, peramivir received approval for limited use in Korea in emergency cases. Approximately 50 individuals were treated under emergency use in Korea.
In June 2006, BioCryst Pharmaceuticals and Green Cross Corporation entered into an agreement that granted Green Cross Corp. the right to develop and commercialize peramivir in South Korea. As part of the agreement, Green Cross Corp. paid to BioCryst a one-time license fee. BioCryst will receive a double-digit royalty on all commercial sales, with the royalty rate being higher for non-commercial sales made to the S. Korean Government.
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 1,800 patients with complicated and uncomplicated influenza. In January 2010, Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name Rapiacta(R) to treat patients with influenza. For more information about peramivir please visit BioCryst's Web site at http://www.biocryst.com/peramivir.
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 that are in 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). Additionally, BioCryst has a third product candidate, BCX4208--a next generation PNP inhibitor--in mid-stage trials for the treatment of gout. 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 BioCryst's Web site at www.biocryst.com.
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 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 development programs 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; 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 our projections and forward-looking statements.
SOURCE: BioCryst Pharmaceuticals, Inc.
BioCryst Pharmaceuticals, Inc.
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