May 27, 2003
European Commission Expands the Indication of Viread, Gilead's Once-Daily Treatment for HIV, to Include Treatment-Naive Patients
FOSTER CITY, Calif., May 27, 2003 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted Marketing Authorisation to expand the indication of Viread(R) (tenofovir disoproxil fumarate) to include the product's use in antiretroviral-naive HIV infected patients in all 15 member states of the European Union. With the extension of this indication, Viread is now approved in Europe for broad use in combination with other antiretrovirals for the treatment of HIV-1 infected adults over 18 years of age, including patients initiating antiretroviral therapy as well as previously treated patients. The Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), issued a positive opinion to expand Viread's indication in February 2003. The Commission's decision to expand Viread's indication is based on 48-week results from Gilead's Study 903 in 600 treatment-naive patients infected with HIV, including patients with a high viral load (greater than 100,000 copies/mL).
"While patients with HIV are living longer due to advancements in antiretroviral therapies, there is still significant need in Europe and around the world for a long-term therapy that can treat diverse patient populations -- from treatment-naive to treatment-experienced patients," commented Brian Gazzard, MD, Chelsea and Westminster Hospital and Clinical Research Director, Imperial College, London. "Viread's proven safety and efficacy in all patient populations, combined with its favorable resistance profile and once-daily dosing, provide physicians and their patients with a much needed tool in battling HIV."
Viread was first authorized for sale in the European Union in February 2002 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients experiencing early virological failure. The Committee originally recommended Marketing Authorisation under exceptional circumstances on the basis of the safety and efficacy data submitted for Viread, which included data from studies of the drug in treatment-experienced HIV-infected patients.
"We are pleased with the European Commission's decision to expand Viread's indication," said John C. Martin, PhD, President and CEO, Gilead Sciences. "Study 903 illustrates the role Viread can play in first line regimens, and a broad indication enables European physicians to better design the most effective regimens for patients across all stages of HIV treatment."
Currently more than 560,000 people in Western Europe are living with HIV, with approximately 30,000 new infections occurring each year.
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 from this study were presented at the 10th Conference on Retroviruses and Opportunistic Infections in Boston, Massachusetts in February 2003.
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 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, 2002 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 1-650-574-3000 or visit www.viread.com.
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc. Susan Hubbard, 650/522-5715 (Investors) James Loduca, 650/522-5908 (Media)
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