March 12, 2002
Gilead Initiates Early Access Program for Adefovir Dipivoxil, Investigational Treatment for Chronic Hepatitis B Infection
Program Open for Patients Without Treatment Options Due to Lamivudine Resistance
"Less than half of patients with chronic HBV are candidates for interferon alpha, and resistance to lamivudine is a key factor in treatment failures. This leaves a large patient population without a viable treatment, many of whom are at serious risk for disease progression," said Robert Perrillo, MD, Ochsner Clinic, New Orleans, LA. "The Adefovir Dipivoxil Chronic Hepatitis B Early Access Program will provide access to a drug that may represent the best hope for these patients."
Early access programs are part of an effort by the U.S. Food and Drug Administration (FDA), European regulatory agencies and the pharmaceutical industry to make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases.
Physicians will be required to evaluate patients at baseline and after one month on therapy, then every two months until drug discontinuation or study termination following the protocol-specified guidelines. Patients enrolled in the U.S. Early Access Program will receive adefovir dipivoxil via their physician until the drug has been licensed for marketing by the U.S. Food and Drug Administration and is commercially available, or until the program is terminated by Gilead Sciences. A similar program was initiated in France in July 2001 and has enrolled 278 patients to date.
"Providing advanced care to patients through improved therapeutics is at the core of the Gilead mission," said John C. Martin, PhD, President and CEO, Gilead Sciences. "Initiating this program is a significant step toward providing early access to adefovir dipivoxil to patients who have become resistant to lamivudine."
About Adefovir Dipivoxil
Data from two pivotal Phase III studies were released in 2001. All primary and secondary efficacy endpoints were achieved, and the safety profile of adefovir dipivoxil 10 mg over 48 weeks of dosing was similar to placebo. Study 437 is a Phase III clinical trial evaluating the safety and efficacy of adefovir dipivoxil once daily as monotherapy compared to placebo in 515 hepatitis B "e" antigen-positive patients with chronic HBV infection and compensated liver function. Results from this study were presented at the 52nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2001.
Study 438 is an ongoing Phase III clinical trial that enrolled 185 patients with precore mutant HBV, or hepatitis B "e" antigen-negative virus, and compensated liver function. This two-year study is being conducted in Australia, Canada, France, Greece, Israel, Italy and Southeast Asia. Preliminary results were released in September 2001 and will be presented at the 37th annual meeting of the European Association for the Study of the Liver (EASL) in Madrid in April 2002. Data from these studies will comprise the core of the regulatory filing packages in both the United States and Europe. To further evaluate the long-term safety and resistance profiles of adefovir dipivoxil, some patients are continuing on Studies 437 and 438 for an additional three years of treatment.
Data from additional studies of adefovir dipivoxil in a variety of patient populations, including those with lamivudine-resistant HBV, patients with compensated and decompensated liver disease, post-liver transplant patients and patients co-infected with HBV and HIV, also were presented at AASLD in November 2001, and further data will be presented at EASL in April 2002. To date, Gilead has provided access to adefovir dipivoxil through Study 435 to approximately 400 patients with lamivudine-resistant chronic HBV infection 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 for its ultimate intended use.
Chronic Hepatitis B Virus Infection
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 safety, efficacy and resistance profile of adefovir dipivoxil observed to date may not be observed following longer periods of treatment, risks related to Gilead's ability to complete regulatory filings as anticipated, the risk that the FDA and other regulatory agencies could require longer-term safety and efficacy data prior to approval, and other risks related to regulatory approval of adefovir dipivoxil. 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.
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