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| |  FDA Approves Cold Sore Treatment Docosanol 10% Cream, Over-The-Counter SAN DIEGO, CA -- June 1, 2000 -- Avanir Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has notified the company that its new drug application (NDA) for docosanol 10% cream is approvable for marketing in the United States. When final labeling is approved by the FDA, the cream will be the first FDA-approved product in the cold sore market able to be sold without prescription. Docosanol 10% cream is intended as a topical treatment for oral-facial herpes commonly known as cold sores or fever blisters, and will be the company's first FDA-approved product. "We are delighted by the FDA's decision," said Gerald J. Yakatan, Ph.D., Avanir's chief executive officer and president. "It is the culmination of a long development program and great news for our shareholders and the nation's 50 million cold sore sufferers. We are well down the road with the FDA on labeling and will continue to work towards a mutually agreeable label in a timely manner." Avanir recently signed an agreement with SmithKline Beecham Consumer Healthcare for manufacturing and marketing rights to docosanol in the U.S. and Canada. Avanir will receive up to $25 million in licensing fees plus royalties from the licensing agreement. "FDA's decision to allow docosanol to go directly to the over-the-counter (OTC) market provides us access to the largest segment of cold sore sufferers," noted Dr. Yakatan. "SmithKline Beecham's expertise and experience in the OTC area should enable us to maximize this opportunity and consequently, shareholder value." Eighty percent of adults in the United States are carriers of herpes simplex 1 (HSV-1) infection. Each year, 20 to 40 percent of these develop symptomatic episodes, characterized by the formation of a blister on the upper or lower lip. The number of treatable episodes ranges from 100 to 130 million outbreaks annually. Avanir Pharmaceuticals, based in San Diego, California, develops novel therapeutic products for the treatment of chronic diseases. In addition to docosanol, the company's product development pipeline includes an option to in-license a drug for the treatment of emotional lability in neurodegenerative diseases, expected to enter Phase II/III clinical trials this year. The company also has a drug discovery program in the advanced pre-clinical stage of development for the treatment of the underlying biological causes of allergy and asthma. Other areas of development include our recently patented fully human monoclonal antibody technology and further clinical development on docosanol in additional indications. Avanir is also engaged in preclinical work on a lipid lowering compound and an anti-inflammatory compound. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. Related Link: SmithKline Beecham Consumer Healthcare.
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