Starpharma's VivaGel for HIV prevention gets fast track status from FDA

By E. Janene Geiss

Philadelphia, Jan. 9 - Starpharma Holdings Ltd. announced Monday that the Food & Drug Administration has granted fast track status to VivaGel, an investigational new drug for the prevention of HIV.

"There are currently no approved products for the prevention of HIV infection. The FDA recognizes the potential of VivaGel to address this unmet medical need," John Raff, chief executive officer of Starpharma, said in a company news release.

"VivaGel's New Drug Application will receive priority review which has a shorter review time. Fast track status also provides more opportunity for Starpharma to communicate with the FDA to ensure the success of the VivaGel development program," Raff added in the news release.

Under the FDA Modernization Act of 1997, the fast track drug development program facilitates and expedites the development of products that serve unmet medical needs of serious or life-threatening conditions.

This program provides formal mechanisms for sponsors to communicate with the FDA on product development issues, including clinical trial design.

Under the fast track program, portions of the New Drug Application can be submitted to the FDA before the application is completed, officials said. This early review is expected to shorten FDA approval times significantly, officials said.

VivaGel is being developed as a vaginal microbicide gel to prevent the transmission of genital herpes and HIV. It recently was awarded $20 million by the U.S.-based NIAID, a division of the National Institutes of Health, to accelerate its development.

The commercial opportunity for VivaGel is very significant, both in industrialized nations and the developing world, officials said. In the United States, AIDS, a result of HIV infection, is now the No. 1 cause of death among African-American women between the ages of 25 and 34 and genital herpes affects about 50 million Americans, company officials said.

With no cure currently available for HIV or genital herpes and the limited success of existing prevention strategies, infection rates in the United States and elsewhere are expected to continue to rise sharply, officials said.

Microbicides such as VivaGel now are recognized as a key element in this fight against genital herpes and HIV, officials said.

Starpharma is a Melbourne, Australia, pharmaceutical company focused on nanotechnology.

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