BioCryst Announces Partnerships for Peramivir for Influenza Outside the U.S.
BIRMINGHAM, Ala., Sept 15, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- 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
-- 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).
Peramivir is an anti-viral agent that was discovered by BioCryst which 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 patients with complicated and uncomplicated influenza. BioCryst's partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in Japan this year.
BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer, and inflammatory diseases. BioCryst has discovered and 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 partnerships 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.
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 peramivir may not receive emergency use authorization; that the U.S. government and ex-U.S. governments may choose not to issue a request for peramivir to treat influenza or such requests, if any, may not result in an order or such order, 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.