SmithKline Beecham
This article was originally published in The Tan Sheet
Executive Summary
Obtains exclusive U.S. and Canadian OTC marketing rights for Avanir Pharmaceuticals' 10% docosanol cream for herpes cold sores. In the first 12 months of the agreement, SmithKline will pay Avanir up to $25 mil., comprising an upfront licensing fee and milestone payments tied to product launch and sales performance. Avanir also will receive royalties on product sales. Avanir, which expects FDA action on its NDA by June 3, does not believe the agency's recent draft guidance disfavoring use of OTC antiviral treatments for herpes labialis will hinder agency approval because docosanol uses a different mechanism than the drugs FDA cited (1"The Tan Sheet" March 13, p. 3). The San Diego-based firm plans to initiate the OTC approval process in Canada this summer
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