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July 7, 2003


FDA Approves Anti-Hiv Drug Invented At Emory University

ATLANTA — A one-capsule, once-daily medication discovered at Emory University for the treatment of HIV has been approved by the U. S. Food and Drug Administration (FDA) for commercial use. The drug Emtriva™ (emtricitabine), which will be marketed and distributed by Gilead Sciences, headquartered in Foster City, California, was originally licensed from Emory in 1996 by Triangle Pharmaceuticals, which was later acquired by Gilead.

Emtriva is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It inhibits reverse transcriptase, the enzyme that copies HIV RNA into new viral DNA. By interfering with this process, which is a key to the replication of HIV, Emtriva can help to lower the amount of HIV, or "viral load," in a patient’s body and increase the number of immune system cells called T cells or CD4 cells. These immune-system effects are associated with improved health and decreased likelihood of AIDS-related illnesses.

Unlike many other anti-HIV drugs, Emtriva is taken only once a day as a 200 mg capsule. It is indicated for the treatment of HIV in adults in combination with other antiretroviral drugs and its once-a-day dosing could make it easier for patients to keep up with complex multi-drug regimens. Emtriva was evaluated in Phase I, II and III clinical trials in more than 2,000 patients who have been treated with other HIV drugs as well as patients who have not yet been treated, and was shown to effectively suppress HIV replication when used in combination with other antiretroviral medications.

Emtriva was invented by Emory University scientists Raymond Schinazi, PhD, Dennis Liotta, PhD, and Woo-Baeg Choi, PhD. Dr. Schinazi is professor of pediatrics in the Emory University School of Medicine, a member of the Emory Graduate School of Arts and Sciences faculty and a senior research scientist at the Atlanta Veterans Affairs Medical Center. Dr. Liotta is professor of chemistry in Emory College and the Graduate School of Arts and Sciences. Dr. Choi is president of FOB Synthesis, a drug discovery company located at the Emtech Bio incubator on Emory’s Briarcliff campus.

"We are extremely proud of our Emory scientists and their many years of research dedicated to developing effective therapies for patients with HIV," said Frank Stout, vice president for research at Emory University. "The approval of Emtriva marks an exciting and positive development for thousands of patients."

Gilead is developing a combination drug that will include Emtriva and Viread (tenofovir disoproxil fumarate), Gilead’s first anti-HIV medication, which is a one-tablet, once-daily nucleotide reverse transcriptase inhibitor (NrRTI). Viread was approved by the FDA in October 2001. The combination drug could be available by 2005.

Emory University scientists have been at the forefront of research in HIV and AIDS and pioneering drug discovery for nearly 20 years. Emory scientists are responsible for the discovery of a number of drugs now commonly used to treat HIV. The Emory Center for AIDS Research includes more than one hundred scientists throughout Emory University studying HIV prevention and treatment, and the Emory Vaccine Center is home to one of the largest university vaccine centers in the world and a renowned program in HIV vaccine research.

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