Roche and Trimeris Inc announced data from a second pivotal Phase III study (TORO 2) demonstrating that Fuzeon (enfuvirtide), in combination with other antiretrovirals, provided benefit to treatment-experienced HIV patients at 24 weeks regardless of patient demographics, baseline disease stage or treatment history. In addition, a survey of treatment-experienced patients participating in the Fuzeon pivotal studies found that twice-daily subcutaneous administration was manageable for the majority of patients through 24 weeks of treatment with patient education and support.

Regulatory submissions for Fuzeon were filed in the U.S. and European Union in September for the treatment of HIV-1 infection in combination with other antiretroviral agents. Fuzeon was granted priority review status in the U.S. in October, establishing a target six-month review period. Unlike existing anti-HIV drugs that work inside the cell, Fuzeon has a unique mechanism of action that is designed to block HIV before it enters the human immune cell. Consequently, Fuzeon is active against HIV that is resistant to
the currently available classes of anti-HIV drugs.

"The studies on Fuzeon presented today in Glasgow are yet another important milestone for Fuzeon," said Dr. Dani Bolognesi, CEO, Trimeris. "These data further support and confirm the robustness of the Phase III 24-week clinical data for Fuzeon."