Gilead Sciences on Wednesday announced that the company is returning the rights to its experimental HIV nucleoside reverse transcriptase inhibitor amdoxovir (DAPD) to Emory University and the University of Georgia. The company gained the rights to the drug when it bought pharmaceutical firm Triangle Pharmaceuticals last year, which had licensed the experimental medication from the two universities that initially discovered the drug's active compounds. To date, DAPD has been evaluated in Phase II clinical trials, and developers believe it may be useful in treating drug-resistant HIV infections. Gilead said it was ending its licensing agreement with the universities due to strategic reasons. The company plans to continue development of experimental protease inhibitor GS 9005 and an enhanced version of its nucleotide reverse transcriptase inhibitor Viread. Gilead also is developing a single pill that combines Viread with its nucleoside drug Emtriva.
Gilead officials say the company will meet its ongoing obligations with respect to existing DAPD clinical trials and will cooperate with the universities during the transition of this technology to a new licensee. Triangle entered into a licensing agreement with the universities in 1996 for worldwide rights to the drug, which transferred to Gilead when Triangle was purchased. Gilead will transfer to the universities data measuring toxicity, efficacy, and other effects, including the Investigational New Drug application filed with the Food and Drug Administration to develop the medication.
"Amdoxovir has great potential for salvage therapy in HIV-infected individuals," said Mary L. Severson, 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 National Institutes of Health-sponsored clinical trials." DAPD has previously been tested in humans for the treatment of chronic hepatitis B infection.