FDA Advisory Committee Unanimously Supports Approval of Gilead's Adefovir Dipivoxil to Treat Chronic Hepatitis B

BETHESDA, Md., Aug 6, 2002 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously voted in support of approval of the company's investigational antiviral agent, adefovir dipivoxil 10 mg, for the treatment of chronic hepatitis B. The committee's positive recommendation followed today's presentation by Gilead and the FDA of efficacy and safety data from clinical studies of adefovir dipivoxil in a broad range of patients with 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
Worldwide, there are approximately 350 million chronic carriers of hepatitis B, of which approximately one million die each year from complications of the disease, making chronic hepatitis B one of the 10 most common causes of death. Complications of chronic hepatitis B include cirrhosis (scarring of the liver), liver failure and primary liver cancer (hepatocellular carcinoma). Between one-quarter and one-third of people with chronic hepatitis B are expected to develop progressive liver disease. Patients infected with the precore mutant strain of hepatitis B may be predisposed to more severe and progressive liver injury. Precore mutant hepatitis B infects up to approximately 50 percent of the 350 million chronic hepatitis B carriers worldwide and is most prevalent in countries of the Mediterranean and Southeast Asia, where between 30-80 percent of chronic hepatitis B patients are estimated to be infected with this strain.

    About Adefovir Dipivoxil
Adefovir dipivoxil, a nucleotide analogue for the potential treatment of chronic hepatitis B, works by blocking HBV DNA polymerase, an enzyme involved in the replication of HBV in the body. In clinical studies, adefovir was shown to provide a sustained antiviral effect in treatment-experienced and treatment-naive patients, as well as in those with virus resistant to lamivudine (a drug used to treat chronic hepatitis B) or with a mutant strain of hepatitis B ("precore mutant hepatitis B"). The most common side effects reported in clinical studies of adefovir dipivoxil were headache, asthenia (weakness), pharyngitis and abdominal pain. Study results have demonstrated that to date no adefovir dipivoxil-associated resistance mutations have been identified in patients treated up to 136 weeks. The FDA will consider the Antiviral Drugs Advisory Committee's recommendations as it completes its priority review of adefovir dipivoxil. As an investigational compound, adefovir dipivoxil has not yet been determined safe or efficacious in humans for its ultimate intended use.

    Early Access Program
Earlier this year, Gilead announced the initiation of an early access program to provide adefovir dipivoxil to people with chronic hepatitis B who are 16 years or older and have shown resistance to lamivudine and are at risk for disease progression. To date, nearly 600 patients have enrolled in adefovir dipivoxil early access programs in the United States, Australia, Canada, France, Portugal, Spain and the United Kingdom. Gilead expects to initiate early access programs in Germany, Italy and other European countries as regulatory approvals are obtained.

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.

    Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has five marketed products and focuses its research and clinical programs on anti-infectives, including antivirals, antifungals and antibacterials. Headquartered in Foster City, CA, Gilead has operations 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. 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.
For more information on Gilead Sciences, please visit the company's Web site at www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).

CONTACT:          Gilead Sciences
                  Susan Hubbard, 650/522-5715 (Investors)
                  Amy Flood, 650/522-5643 (Media)

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