GILEAD LICENSES TENOFOVIR FOR DEVELOPMENT AS A MICROBICIDE

U.S. drugmaker Gilead Sciences has announced an agreement under which the company will grant the rights to develop, manufacture and, if proven efficacious, distribute its antiretroviral tenofovir as a microbicide to prevent HIV infection. The groups receiving the license are the International Partnership for Microbicides (IPM) and Conrad.

Tenofovir gel has previously been evaluated in a Phase I study, and Phase II studies are being conducted through the NIH's HIV Prevention Trials Network.

Under the terms of the agreement, Gilead will provide to both IPM and Conrad a royalty-free license to develop and distribute tenofovir as a microbicide in approximately 100 resource-limited countries hardest hit by the HIV epidemic. Gilead will also facilitate the manufacturing of tenofovir by third-party contract manufacturers to supply ongoing clinical studies for two years, after which time other suppliers, including generic manufacturers, may be used.

The tenofovir patent holders have agreed to waive their right to a royalty on sales of products containing drug in the 97 developing countries served by the Gilead Access Program, according to the company.

IPM is an organization working to develop and deliver safe and effective microbicides. Conrad is a cooperating agency of U.S. Agency for International Development committed to preventing the spread of HIV and other sexually transmitted diseases.