BioCryst and moksha8 Announce Approval for the Importation & Use of peramivir in Mexico

BIRMINGHAM, Ala., Jan. 12 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain.  moksha8 has informed BioCryst that it has also filed for regulatory approval of peramivir in Brazil.  Peramivir is the only intravenous (i.v.) anti-viral that is currently available under an Emergency Use Authorization (EUA) in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.  

"We are pleased that the Mexican Government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals.  "The relationship between BioCryst and moksha8, established several months ago, is producing the near-term results we desired.  We are prepared to respond to any peramivir order we may receive under this authorization from Mexico."

"Bringing important novel products to patients in need in Mexico and Brazil is core to our vision," said Ayse Kocak, Head of moksha8 in Mexico.  "The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government's commitment to public health."

In September 2009, moksha8 signed a binding letter of intent to exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, in certain Latin American countries, including Brazil and Mexico.  moksha8 has established broad commercial operations in Mexico and Brazil, the two largest pharmaceutical markets in Latin America.  Together they represent 75% of a $30 billion market in Latin America.  

Mexico is the fifth country to order or authorize use of peramivir during this flu season.  The other countries include the U.S., Israel, Australia and South Korea.  

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.  Shionogi & Co., Ltd. and Green Cross Corp. have filed for regulatory approval in Japan and Korea respectively.  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 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 moksha8

moksha8 was founded in December 2006 by Simba Gill and TPG Biotech, and has raised significant financing from top-tier private equity and venture capital firms, including TPG Biotech, Montreux Equity Partners and Votorantim Novos Negocios, the venture capital and private equity arm of Votorantim, one of Brazil's largest privately held conglomerates.  moksha8 is positioned as the partner of choice for both pharmaceutical and biotechnology companies seeking to capture value from their products in high growth emerging markets.  moksha8 has established commercial operations in key geographies in Latin America including Sao Paulo and Mexico City.  moksha8 provides high quality medicines to some of the fastest growing markets of the world.

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.

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, 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.

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SOURCE BioCryst Pharmaceuticals, Inc.