Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Oct 1 2009

Astellas Pharma Canada, Inc. (Astellas) and Theravance, Inc. (NASDAQ: THRX) announced today that Health Canada has approved VIBATIV(TM) (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. Telavancin is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance. This is the second approval for telavancin this year, following the approval on September 11, 2009 by the U.S. Food and Drug Administration.

"We believe telavancin can make important contributions to the ongoing fight against microbial resistance," said Fumiaki Sakurai, President, at Astellas Pharma Canada, Inc. "We look forward to being able to offer a new therapeutic option to physicians and the patients who may benefit from telavancin."

"The approval of telavancin in Canada and the recent approval in the U.S. focus attention on the urgent need for new antibiotics to treat Gram-positive infections caused by MRSA," said Rick E Winningham, Chief Executive Officer of Theravance. "We believe that telavancin will be an important option for the treatment of Gram-positive complicated skin and skin structure infections."

Telavancin will be marketed and sold by Astellas and is expected to be commercially available in Canada in early 2010.