March 21, 2002
Gilead Submits New Drug Application to U.S. FDA for Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B
"Current therapeutic options are limited, and the need for safe, effective and durable treatments for patients with chronic hepatitis B is an urgent one," said John C. Martin, PhD, President and CEO, Gilead Sciences. "The achievement of this milestone marks an important advancement toward our goal of providing a potential new treatment to the many patients suffering from chronic hepatitis B. It also marks the second NDA submission for a novel Gilead antiviral in less than one year, underscoring our expertise and our leadership role in anti-infective therapies."
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 FDA may not agree that the safety and efficacy data from pivotal studies are sufficient for marketing approval, the risk that the FDA may require additional studies and data prior to approval, the risk that the FDA may not review the application in 2002 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.
Copyright (C) 2002 Business Wire. All rights reserved.