Triangle Pharmaceuticals Inc announced that the Marketing Authorisation Application (MAA) for emtricitabine for the treatment of HIV infection was submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) and that the EMEA has accepted the application for review. Triangle previously submitted a New Drug Application (NDA) for emtricitabine for the treatment of HIV infection to the U.S. Food and Drug Administration (FDA) which was accepted for review on November 1, 2002.
Emtricitabine is a once-a-day nucleoside reverse transcriptase inhibitor (NRTI). The tradename for emtricitabine in Europe is under review. In the United States and other countries, emtricitabine will be marketed under the Coviracil tradename.
"We are very pleased to have delivered on our earlier commitment to complete the European filing around the end of 2002," commented Daniel G. Welch, Chairman and Chief Executive Officer of Triangle. He continued, "We believe, pending marketing clearance, emtricitabine may offer patients and physicians in Europe an important new medicine for the management of HIV disease."
The MAA includes data from over 2,000 patients and is supported by two pivotal trials, FTC-303 and FTC-301. The MAA will be reviewed under the centralized licensing procedure, which, if approval is granted, provides a marketing license valid in all member states of the European Community.
On December 4, 2002, Gilead Sciences Inc and Triangle announced that they signed a definitive agreement under which Gilead plans to acquire Triangle. The transaction has been structured as a two-step acquisition comprised of a cash tender offer for all of the outstanding Triangle common stock at $6.00 per share, followed by a cash merger in which Gilead would acquire any remaining outstanding Triangle common stock at $6.00 per share. The transaction is expected to close in the first quarter of this year, subject to customary closing conditions.