Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

Sep 15 2009

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed binding letters of intent with three partners who will 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, within their territories outside the U.S. Each partner will immediately begin meeting with key government officials in their respective territories to discuss peramivir's availability during this global health emergency.

BioCryst's new partners include:

• moksha8 Pharmaceuticals, Inc. for Brazil and Mexico

moksha8 Pharmaceuticals, Inc. has established broad commercial operations in Brazil and Mexico, the two key countries in Latin America that represent 75% of the $30 billion Latin America pharmaceutical market. The Company is currently selling over $200 million of products in the anti-infectives, central nervous system and inflammation indications under partnerships with Roche and Pfizer. Products in the Company's portfolio include key brands such as Rocephin, Bactrim, Lexotan and Rivotril.

• NT Pharma (Group) Co., Ltd. for China

NT Pharma was established in 1995 and has over 1,000 employees, corporate offices in Hong Kong and sales and marketing subsidiaries in Shanghai, Beijing, Guangzhou, Suzhou, Taizhou and Hainan for the distribution of pharmaceutical products including prescription medicine and vaccines. In 2009, the Group expects to achieve sales revenue of RMB 3 billion (U.S.$440 million), with a nationwide network that covers more than 100 cities, 1,500 hospitals and 12,000 points of vaccination, reaching over 90% of China's urban population.

• Neopharm Group for Israel

The Neopharm Group is a leading provider of innovative integrated solutions across the health care spectrum. Throughout the years the Group has evolved into a diversified health care company. Building leadership and combining strengths in the areas of branded pharmaceuticals and biological products, vaccines (including H1N1 vaccine), hospital products, orphan drugs, medical devices and diagnostics has enabled the Neopharm Group to become the 2nd largest group in the Israeli healthcare market with annual sales of more than U.S.$300 million.

"We are pleased to have established these relationships with strong partners who have extensive experience, capabilities, and regulatory contacts within these important markets," said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. "In today's pandemic environment, such partnerships are the most expedient and effective option for getting peramivir to patients in need. BioCryst will continue to evaluate and develop partnerships outside the U.S. We are currently exploring other opportunities to expand the geographic reach of peramivir."

Peramivir U.S. Program Status

• The pre-emergency use authorization (EUA) review of intravenous (i.v.) peramivir announced in May has continued to progress. U.S. Government agencies are considering the future option of providing peramivir through an EUA in the event of a severe influenza outbreak with significant hospitalizations.

• BioCryst has finalized its plans for peramivir Phase 3 studies intended to support U.S. regulatory approval for influenza. Expenses for initial steps of the Phase 3 studies are covered under our original U.S. Department of Health and Human Services (HHS)/Biomedical Advanced Research and Development Authority (BARDA) contract awarded to BioCryst in 2007. BioCryst is currently in the process of obtaining the appropriate Health Authority and IRB/Ethics Committee approvals and is recruiting investigators in the U.S. and abroad. BioCryst plans to initiate enrollment of these trials once all approvals are granted and when we have secured sufficient funding to support their completion.

• Discussions between BioCryst and the U.S. Government are continuing regarding a number of issues including necessary funding from HHS/BARDA for these Phase 3 studies, a potential stockpiling order, and use of our excess peramivir active pharmaceutical ingredient (API).