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the end of Amdoxovir?
Feb 25, 2004

Dr. Pierone,

I hope you're better at understanding this than me. The way I take it as that this notice might imply that Amdoxovir is ended as a hiv research agent, but what confounds me a bit is the bottom when there is mention of it being potent. So what do you think, is this basically a dead product or what?

Meghan

Gilead Sciences Ends Licensing Agreement for Development of Amdoxovir (DAPD)

Gilead Sciences on January 28, 2004 announced the company will end its licensing agreement with two US universities for development of amdoxovir (DAPD) for the treatment of HIV infection and for HBV infection.

Gilead told the two academic centers, Emory University and the University of Georgia, that it is ending the agreements for strategic reasons. Following is an edited version of the Gilead announcement:

Also known as DAPD, amdoxovir is an investigational guanosine nucleoside analogue currently in Phase II development for the treatment of HIV. Amdoxovir has also been tested in humans for the treatment of chronic hepatitis B infection and is currently in Phase II clinical trials under a U.S. IND.

Gilead will meet its ongoing obligations with respect to existing clinical trials and is committed to cooperating with the universities during the transition of this technology to a new licensee.

In March 1996, Triangle Pharmaceuticals, Inc. entered into a licensing agreement with Emory University and the University of Georgia Research Foundation for worldwide rights to amdoxovir. In January 2003, Gilead acquired Triangle Pharmaceuticals. In accordance with the licensing agreement, Gilead will transfer toxicity, efficacy and other data including the IND to the universities.

"Gilead remains committed to developing novel compounds to fight HIV," said John C. Martin, PhD, President and CEO of Gilead Sciences. "We continue to focus resources on the development of other promising candidates in our pipeline, including the co-formulation of Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine) into a single fixed-dose combination tablet, and two investigational agents, GS 7340, an amidate prodrug of tenofovir, and GS 9005, a [HIV] protease inhibitor."

"Amdoxovir has great potential for salvage therapy in HIV infected individuals," said Mary L. Severson, PhD, JD, Chief Technology Officer at Emory University. "Emory and the University of Georgia Research Foundation are committed to the continued development of this drug and the ongoing NIH-sponsored clinical trials ACTG 5118 and ACTG 5165."

02/02/04

Source Gilead Sciences. www.gilead.com

Response from Dr. Pierone

It sounds like Amdoxovir is a dead product at this point. Apparently it had potential eye toxicity (lens opacities) and this may have led to Gilead dropping its development.



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