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Published on 11/28/2005 in the Prospect News Biotech Daily.

BioCryst submits application for injectable peramivir, a flu vaccine that may even work against avian flu

By E. Janene Geiss

Philadelphia, Nov. 28 - BioCryst Pharmaceuticals, Inc. said Monday that it has submitted an Investigational New Drug Application to the U.S. Food and Drug Administration for injectable formulations of peramivir, the company's influenza neuraminidase inhibitor.

In preclinical studies, peramivir has shown potent, broad-spectrum activity against multiple strains of flu, including the H5N1 virus or avian flu, according to a company news release.

"We believe an injectable formulation of peramivir has considerable potential for treating life-threatening strains of influenza," chairman and chief executive officer Charles E. Bugg said in the release.

"This IND filing is an important step toward the initiation of clinical studies with injectable peramivir. If the FDA approves our development plan we anticipate phase 1 human clinical testing could begin early next year," he added.

BioCryst said it is proposing to develop two injectable formulations of peramivir, including an intravenous formulation for the treatment of acutely ill patients and an intramuscular injectable formulation for treating patients in the early stages of infection.

Both of these development programs are being pursued in collaboration with research groups at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, officials said.

BioCryst is a Birmingham, Ala., pharmaceutical company that designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular diseases, autoimmune diseases and viral infections.


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