Emtricitabine (Emory University/Glaxo Wellcome/Triangle Pharmaceuticals)

Triangle Pharmaceuticals has licensed the development rights to emtricitabine (FTC), an antiviral nucleoside analog that is structurally related to 3TC, from Emory University [207618]. It is in phase III trials for HIV [324921] and in phase I/II trials for hepatitis B (HBV) [305302]. In June 1999, Triangle and Abbott Laboratories entered into an alliance for the development and marketing of six antiviral products, including FTC [326824]. An NDA was expected to be filed in 2000 [324921]. US-05814639 has been issued covering FTC [300465]. In April 2000, a report appeared in the South African media which suggested that a Triangle-sponsored trial (FTC-302), commenced in August 1999, had been halted [361984]. A total of 470 patients had been enrolled on the trial, which is a comparison of Coviracil and lamivudine, both drugs being used in combination with d4T and nevirapine. Patients with high viral loads received efavirenz instead of nevirapine. There was a higher than expected incidence of liver toxicity in this study and, in two cases, this liver toxicity resulted in death. Initially, Triangle reported that the trial was ongoing, although no additional patients were being enrolled at the time. However, the company received notification from the Medicines Control Council (MCC) in South Africa informing it that study FTC-302 should be terminated. The company is in ongoing discussions with the MCC [361792,361793]. Subsequently, the FDA also issued a hold on the trial, which is being carried out in South Africa under a US IND, and indicated that as a result of factors leading to this decision, study FTC-302 may not provide adequate support as part of an NDA submission. The planned NDA filing may now be delayed until the second half of 2001 and Triangle will discuss with the FDA any additional data required for the NDA application [361984].