Theravance, Inc. (NASDAQ/exchange>: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.
"We are very pleased with the FDA's approval of VIBATIV, and extremely excited about the prospect of bringing this new medicine to the market," said Rick E Winningham, Theravance's Chief Executive Officer. "This is a significant event that marks the first approved indication for VIBATIV and validates Theravance's strategies in drug discovery and development. We believe that VIBATIV will become an important medicine addressing the urgent medical need for new antibiotics to treat Gram-positive infections caused by MRSA."
"VIBATIV has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said Ralph Corey, M.D., Professor of Medicine at the Duke University Medical Center and the principal investigator in the ATLAS program. "I believe VIBATIV will be a welcome addition for physicians treating this serious infection."
"VIBATIV will provide physicians with a new option to help their patients and demonstrates our long-standing commitment to the anti-infective community," said Seigo Kashii, President and Chief Executive Officer at Astellas Pharma US, Inc. "This approval milestone is a good example of Astellas' strong focus on improving the health of patients around the world through innovative medications."
VIBATIV will be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009. Theravance will collaborate with Astellas in marketing in the United States for the first three years following approval.