ANTI-HIV DRUG CONTINUES DEVELOPMENT THROUGH PHARMACEUTICAL COLLABORATION

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ANTI-HIV DRUG CONTINUES DEVELOPMENT THROUGH PHARMACEUTICAL COLLABORATION
22 September 2004 - Emory University

Incyte Corporation and Pharmasset, Ltd., have announced a licensing collaboration to continue development and commercialization of an anti-HIV drug invented by scientists at Emory University. The antiretroviral drug Reverset, also known as RVT, D-D4FC or DPC-817 is currently in Phase IIa clinical trials and is targeted to HIV patients who have developed resistance to common antiretroviral drugs.

Reverset was invented by Emory University scientists Raymond F. Schinazi, PhD and Dennis Liotta, PhD. It originally was licensed in 1998 to Pharmasset, a company partially co-founded by Emory University scientists to discover, develop, and commercialize novel antiviral and anticancer drugs. As part of the collaborative agreement between the companies, Incyte is sub-licensing certain of the rights originally licensed by Emory to Pharmasset.

Reverset is an oral, once-a-day nucleoside analog that inhibits HIV-1 and HIV-2 by targeting the reverse transcriptase, which is part of the cellular machinery that allows the virus to copy itself. In preclinical studies Reverset inhibited the replication of wild type and mutant strains of HIV that commonly arise after patients are treated with the antiretroviral drugs zidovudine and lamivudine. The preclinical studies also showed that Reverset does not produce a common toxicity associated with certain anti-HIV drugs that can lead to serious and sometimes life-threatening bone marrow suppression.

Following approval by the FDA as an Investigational New Drug Reverset was tested in Phase I safety studies in 56 HIV-positive male volunteers. It was well tolerated, with mild effects that occurred no more frequently than with placebo. Pharmasset is currently conducting a dose-escalating Phase II clinical trial of Reverset in HIV patients who have not been treated with other anti-HIV drugs. A second Phase II trial, testing Reverset in combination with other antiretroviral drugs in patients already undergoing drug therapy.

"We are extremely proud of the continued success of our Emory scientists in discovering innovative new drugs to treat HIV," said Frank Stout, Emory vice president for research. We are optimistic that this collaboration between Incyte and Pharmasset will further accelerate the development and availability to patients of this new therapy."

According to Dr. Schinazi, "We are very pleased that the basic science conducted at Emory University resulted in a highly potent drug, Reverset, that is the cornerstone technology of this collaboration and license agreement. The Pharmasset-Incyte deal will accelerate the clinical development of this nucleoside towards a U.S. FDA New Drug Application filing and eventual commercialization. Scientifically, Reverset has the potential to become the best drug in its class and that scenario would result in a win-win situation for Emory, Pharmasset, Incyte and the individuals infected with HIV."

Emory University is a world leader in AIDS research, addressing the epidemic through the development of widely used anti-HIV drugs and promising HIV vaccine candidates, renowned research in prevention and behavioral sciences, and clinical trials within highly regarded treatment facilities. The Emory Center for AIDS Research is a designated NIH research center.

http://www.emory.edu

About: Emory University
Emory University is home to nine major academic divisions, numerous centres for advanced study, and a host of prestigious affiliated institutions. In addition to Emory College, the University encompasses a graduate school of arts and sciences; professional schools of medicine, theology, law, nursing, public health, and business; and Oxford College, a two-year undergraduate division on the original campus of Emory in Oxford, Ga.

Emory was founded at Oxford by the Methodist Church in 1836. Led by President James W. Wagner, an award-winning teacher and scholar, the University has 11,300 students and 2,500 faculty members who represent all regions of the United States and more than 100 foreign nations.

Emory University is known for its demanding academics, outstanding undergraduate college of arts and sciences, highly ranked professional schools and state-of-the-art research facilities. For more than a decade Emory has been named one of the country's top 25 national universities by U.S. News & World Report. In addition to its nine schools, the university encompasses The Carter Center, Yerkes National Primate Research Center and Emory Healthcare, a comprehensive metropolitan health care system.

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