August 06, 2002
FDA Advisory Committee Unanimously Supports Approval of Gilead's Adefovir Dipivoxil to Treat Chronic Hepatitis B
The FDA will consider the Advisory Committee's recommendations as it completes its priority review of the adefovir dipivoxil New Drug Application (NDA), submitted on March 21, 2002. If approved, adefovir dipivoxil will be the first commercially available nucleotide for use in the treatment of chronic hepatitis B and the first new treatment approved for the disease since 1998.
Advisory committee members unanimously agreed that the adefovir dipivoxil pivotal study data supports the drug's safety and efficacy in patients with chronic hepatitis B. Several Committee members suggested that monitoring for changes in laboratory markers of renal function in patients with impaired renal function should be included in the adefovir dipivoxil product label.
"Significant numbers of patients with chronic hepatitis B in the United States are showing inadequate responses to available therapies due to increased development of resistance and problematic side effects. Today's discussion brings us one step closer to providing an important new treatment option for these patients," said John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. "Based on data from Phase III studies, we believe adefovir dipivoxil has the potential to safely and effectively treat patients with chronic hepatitis B, including those with lamivudine-resistant virus or other hard-to-treat forms of the disease. We are particularly pleased with the Committee's recognition of Gilead's rigorous clinical studies of adefovir dipivoxil, which included analyses of liver histology."
The Committee's recommendation marks the second FDA Antiviral Drugs Advisory Committee endorsement for a novel Gilead antiviral in less than a year's time. Viread(R) (tenofovir disoproxil fumarate), the company's antiretroviral agent for the treatment of human immunodeficiency virus (HIV) infection, was approved in the United States in October 2001 and in the European Union in February 2002.
About Hepatitis B
About Adefovir Dipivoxil
Early Access Program
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 follow the advice of the advisory committee and may refuse to grant regulatory approval for adefovir dipivoxil, may grant approval for a more limited indication or may require significant post marketing commitments. 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, 2001 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.
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