GILEAD REDUCES COST OF VIREAD BY NEARLY 37 PERCENT FOR DEVELOPING COUNTRIES

Gilead Sciences said it will reduce the price of its HIV therapy Viread (tenofovir disoproxil fumarate) by nearly 37 percent of the original no-profit price for developing countries. The price reduction is due to improvements in the manufacturing process and increased economies of scale.

Through its Gilead Access Program, the firm offers Viread at a no-profit price for African nations and 15 other "least developed" countries around the world, as classified by the United Nations.

The drug will now be made available to any private or public program treating people with HIV/AIDS for $24.71 per 30-day supply, which represents Gilead's costs for manufacturing the drug and administering the program.

"Since the launch of this program, Gilead has continued to invest in process improvements that could reduce our manufacturing costs," said John Martin, president and chief executive officer. "Now that we have identified improvements, we are able to lower our manufacturing cost and consequently our not-for-profit price."

Additionally, Gilead intends to make a fixed-dose combination of pharmaceutical brands Viread and Emtriva (emtricitabine) available through the program as soon as Emtriva receives approval from the Food and Drug Administration. A decision is expected in mid-September.

Both pharma names Viread and Emtriva are indicated to be used with other antiretroviral agents for treating HIV-1 infection among adults.

Wednesday, May 19, 2004

FDA GRANTS PRIORITY REVIEW TO GILEAD'S CO-FORMULATION OF VIREAD, EMTRIVA

Shares of Gilead Sciences Inc. jumped 8.6 percent after the Food and Drug Administration granted priority review to the company's fixed-dose combination of its pharmaceutical name HIV drugs Viread (tenofovir disoproxil fumarate)and Emtriva (emtricitabine).

Gilead filed a New Drug Application with the FDA for the HIV combination therapy on March 12, and had anticipated a decision by Jan. 12, 2005 based on a 10-month traditional review. With the recent designation of priority review status, the company now expects the FDA to review and make a decision regarding the treatment by Sept. 12.

The proposed co-formulated tablet will contain 300 mg of Viread and 200 mg of Emtriva, and will be administered with at least one other HIV product. Following approval of the fixed dose co-formulation, the two pharma brands will continue to be sold separately, Gilead noted.

The FDA approved Viread in 2001 and Emtriva in 2003.

Gilead shares closed at $62.54, up $4.94, in heavy trading on the Nasdaq.