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Gilead Sciences to Provide Access to Anti-HIV Therapy Viread® in 68 Developing World Countries at No ProfitFoster City, CA -- December 17, 2002Gilead Sciences (Nasdaq: GILD) announced today that the company is developing the Viread Access Program to provide Viread® (tenofovir disoproxil fumarate), the company's once-a-day antiretroviral medication for HIV, at no profit in every country in Africa and in 15 additional countries in other parts of the world classified as "least developed" by the United Nations. "Viread's efficacy, tolerability, resistance profile and once-daily dosing may make the drug strategically important in resource-poor settings," said John Martin, PhD, President and Chief Executive Officer of the company. "We believe that through important new clinical research initiatives and no-profit pricing we will be able to increase access to treatment in the developing world, where HIV/AIDS has taken such a terrible toll." Gilead's program, which will be operational by the second quarter of 2003, will offer Viread to eligible treatment programs in every country in Africa and in an additional 15 other low-income countries. This program will provide Viread at a reduced price that represents only Gilead's cost of manufacturing and distributing the drug and administering the program. Key Features of the Program
Program Details Application forms will be available through a dedicated website to be launched in the first quarter of 2003 and can be submitted via the Internet or by email, mail or fax. The no-profit price for Viread and additional program details will be announced at the time the website is launched. The company will be prepared to ship Viread to qualifying programs as soon as the program details are announced. Independent experts will review applications, and applicant programs will be evaluated based on their ability to sustain an effective treatment program, adequately prescribe and monitor patients, and store and use the drug appropriately. Gilead will take appropriate steps to ensure that Viread shipments reach their intended destination and, to the extent possible, will monitor the recipient programs on an ongoing basis to ensure that quality care is being provided. About Viread In the United States, Viread is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in a controlled study of Viread of 24 weeks duration and in a controlled, dose-ranging study of Viread of 48 weeks duration. Both studies were conducted in treatment-experienced adults with evidence of HIV-1 viral replication despite ongoing antiretroviral therapy. Studies in antiretroviral-naïve patients are ongoing; consequently, the risk-benefit ratio for this population has yet to be determined. Safety Profile The most common adverse events in patients receiving Viread were mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting and flatulence. Laboratory abnormalities observed in clinical studies occurred with similar frequency in the Viread and placebo-treated groups. In clinical practice, a number of adverse events, including renal impairment, nausea, rash and asthenia (weakness) have been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease, or in patients taking concomitant nephrotoxic agents. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. About Gilead Sciences This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2001 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements. ###
Viread is a registered trademark of Gilead Sciences, Inc. For full prescribing information on Viread, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.viread.com. |