October 18, 2001
European CPMP Gives Positive Opinion on Viread™, Gilead’s New Once-Daily Treatment for HIV Infection
Foster City, CA -- October 18, 2001
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Union's Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has recommended granting of the Marketing Authorisation for Viread™ (tenofovir disoproxil fumarate) in the 15 member states of the European Union. The European Commission will consider granting of the final Marketing Authorisation on the basis of the CPMP's recommendation. Gilead anticipates the Marketing Authorisation will be granted in early 2002. Earlier this month, the U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee recommended the marketing approval of Viread in the United States.
Gilead submitted its Marketing Authorisation Application (MAA) for Viread for review under the centralized procedure on May 4, 2001. This application was granted an accelerated review by the CPMP because the product addresses an unmet medical need as defined in the recent CPMP "Points to Consider" document for the assessment of anti-HIV medicinal products. On the basis of the safety and efficacy data submitted for Viread, the committee has recommended the granting of a Marketing Authorisation under exceptional circumstances. The indication recommended by the CPMP is for Viread taken in combination with other antiretroviral agents in HIV infected patients over 18 years of age experiencing early virological failure.
"There are increasing needs across Europe for treatments to combat HIV infection, particularly for individuals who have failed other therapy," said Brian Gazzard, M.D., Chelsea and Westminster Hospital and Clinical Research Director, Imperial College, London. "The rapid review of the Viread application and issuance of a positive opinion by the CPMP is testament to the commitment of regulators in Europe to provide physicians and patients with new HIV treatments as quickly as possible."
"We have worked closely with the rapporteur in France, the co-rapporteur in Spain and the members of the CPMP and EMEA, and are pleased to have received this positive opinion less than six months after our MAA submission," said John C. Martin, Ph.D., President and CEO, Gilead Sciences. "We will continue to work with regulatory authorities to advance Viread toward approval and ensure that this new agent is available to help address unmet medical needs of patients with HIV infection."
Viread is taken as one tablet, once daily with food as part of antiretroviral combination therapy and works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. As an investigational compound, Viread has not yet been determined safe or efficacious in humans for its ultimate intended use.
In addition to studies in treatment experienced patients, Viread is being evaluated in a treatment naive population in an ongoing clinical study (903) being conducted in Europe, South America and the U.S. This 96-week Phase III trial is designed to compare a treatment regimen of Viread, lamivudine (3TC) and efavirenz to a treatment regimen of stavudine (d4T), lamivudine and efavirenz in a blinded fashion in patients who have not previously received antiretroviral treatment. Enrollment in Study 903 was completed in January 2001 with 601 patients, and 48-week data will be available in the first half of 2002.
Expanded Access Program
More than 5,000 patients with advanced HIV infection have enrolled in Viread expanded access programs in Australia, Canada, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, the United Kingdom and the United States. For more information regarding the Viread expanded access program or to request registration materials, physicians in Europe may call 33-1-44-90-34-46, those in Australia may call 800-806-112 and those in the United States and Canada may call 1-800-GILEAD-5.
Gilead Sciences, Inc., headquartered in Foster City, CA, is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development, manufacturing and sales and marketing facilities 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 upon the EMEA, that Viread remains an investigational compound that has not been determined to be safe and effective in humans for its ultimate intended use and that there remain a number of other risks related to regulatory approval of Viread. 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, 2000 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.