February 21, 2003
European CPMP Gives Positive Opinion to Extend the Indication of Viread, Gilead's Once-Daily Treatment for HIV Infection
The indication recommended by the CPMP is for Viread to be taken in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age. This indication is based on the demonstration of benefit of Viread from results of one study in treatment-naive patients, including patients with a high viral load (greater than 100,000 copies/mL), and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (less than 10,000 copies/mL, with the majority of patients having less than 5,000 copies/mL).
Viread was first authorised for sale in the European Union in February 2002. On the basis of the safety and efficacy data submitted for Viread in the original submission, which only included data from studies of the drug in treatment-experienced HIV infected patients, the committee recommended authorisation under exceptional circumstances. The indication recommended by the CPMP was for Viread taken in combination with other antiretroviral agents in HIV infected patients over 18 years of age experiencing early virological failure.
"Today's CPMP opinion is an important step toward expanding our European label for Viread, which we believe will help physicians to design the best antiretroviral treatment regimens for all of their HIV patients," said John C. Martin, PhD, President and CEO, Gilead Sciences. "The rapid review of our submission for label extension underscores the continued need for a product with Viread's unique efficacy and safety profile across all stages of HIV treatment, and we will continue to work closely with the EMEA to ensure the adoption of this opinion."
About Study 903
Study 903 is an ongoing three-year, randomized, double-blind trial designed to compare the efficacy and safety of a treatment regimen of Viread, lamivudine (3TC) and efavirenz to a regimen of stavudine, lamivudine and efavirenz in 600 antiretroviral-naive patients with HIV infection. Study 903 is being conducted in the United States, Europe and South America. Ninety-six-week data were presented earlier this month at the 10th Conference on Retroviruses and Opportunistic Infections in Boston, Massachusetts.
Viread is the first nucleotide analogue reverse transcriptase inhibitor (NtRTI) approved for the treatment of HIV in the United States and Europe. In clinical trials and expanded access programs, approximately 10,000 patients have been treated with Viread alone or in combination with other antiretroviral products for periods up to four years. The drug works by blocking reverse transcriptase, an enzyme involved in the replication of HIV. Viread is dosed as one tablet once daily taken orally with a meal.
Adverse events with suspected relationship to Viread reported in the Summary of Product Characteristics for treatment-experienced and treatment-naive patients include diarrhea, nausea, vomiting, hypophosphatemia, dizziness and flatulence. In clinical practice, adverse events including renal impairment, nausea, rash, asthenia, dyspnea, pancreatitis and lactic acidosis have been reported.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has six marketed products and focuses its research and clinical programs on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in the United States, Europe and Australia.
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. The reader is cautioned that the CPMP opinion is not binding on the EMEA, that the EMEA has not determined that Viread is safe and efficacious for the treatment of HIV in antiretroviral-naive patients, and that there remain a number of risks related to the extension of Viread's indication in the European Union to include the product's use in antiretroviral-naive patients. The reader is cautioned not to rely on these 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.
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