March 26, 2002
Gilead Submits Marketing Authorisation Application for Adefovir Dipivoxil 10 mg for Treatment of Chronic Hepatitis B; EU Application Follows Submission to FDA
"The rapid completion of the Marketing Authorisation Application for adefovir dipivoxil in Europe, following our U.S. NDA submission by less than a week, underscores our commitment to addressing the unmet medical needs in the treatment of chronic hepatitis B," said John C. Martin, PhD, President and CEO, Gilead Sciences. "The breadth of clinical data generated to date for adefovir dipivoxil, including data in precore mutant chronic hepatitis B -- a strain of the virus more common in many European countries -- suggest this drug may be a promising option for many patients suffering from this life-threatening, chronic infectious disease."
The MAA will be reviewed under the centralized licensing procedure, which, if approval is granted, provides a marketing license valid in all the 15 member states of the European Community. Review of the application will be coordinated by the EMEA. The French authorities will act as rapporteur for the application, and the Danish authorities will act as co-rapporteur.
About Adefovir Dipivoxil
Data from two pivotal studies and a number of supportive studies of adefovir dipivoxil in a variety of chronic hepatitis B patient populations will be presented in April at the 37th Annual Meeting of the European Association for the Study of the Liver (EASL). Presentations include data from studies of hepatitis B "e" antigen-positive patients, precore mutant (hepatitis B "e" antigen-negative) patients, those with lamivudine-resistant HBV, patients post-liver transplantation and patients co-infected with HIV. Since 1999, Gilead has provided access to adefovir dipivoxil through Study 435 to approximately 400 chronic hepatitis B patients with lamivudine-resistant HBV who are wait listed for or have received a liver transplant. Adefovir dipivoxil is an investigational compound and has not yet been determined safe or efficacious in humans.
Chronic Hepatitis B
Early Access Program Initiated
For more information regarding the adefovir dipivoxil early access program, or to request program registration materials, physicians may call 1-800-GILEAD-5 or 1-650-574-3000.
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. Such risks and uncertainties include the risk that the EMEA may not agree that the safety and efficacy data from pivotal trials are sufficient for marketing approval, the risk that the EMEA may require additional studies and data prior to approval and the risk that further data from ongoing and future clinical trials may not be as favorable as current data. 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.
For more information on Gilead Sciences, please visit the company's web site at www.gilead.com or call the Gilead Corporate Communications Department at 1-800-GILEAD-5 or 1-650-574-3000.
CONTACT: Gilead Sciences, Inc. Susan Hubbard, 650/522-5715 (Investors) Amy Flood, 650/522-5643 (Media) URL: http://www.businesswire.com Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page.
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