THERAVANCE SUBMITS APPLICATION FOR CSSSI TREATMENT

Theravance announced that the FDA has accepted the company's new drug application (NDA) for its investigational antibiotic telavancin for treating complicated skin and skin structure infections (cSSSIs) caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. The NDA filing triggers a milestone payment of $31 million from Theravance's partner, Astellas Pharma.

The NDA submission is based on data from two large, multinational, double-blind, randomized Phase III clinical studies. In both of these studies (ATLAS 1 and ATLAS 2), which enrolled and treated 1,867 patients in total, telavancin achieved its primary endpoint of non-inferiority to vancomycin. Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections due to resistant bacteria, according to the company.

Theravance entered into a collaboration arrangement with Astellas in 2005 for the development and commercialization of telavancin worldwide. Under the terms of the collaboration, Theravance will lead the development of telavancin for the treatment of cSSSI and hospital-acquired pneumonia, and will collaborate with Astellas on marketing it in the U.S. for the first three years after approval. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.