Theravance, Inc. (NASDAQ: THRX) announced today that it has earned a milestone payment of $20 million for the U.S. Food and Drug Administration (FDA) approval of VIBATIV™ (telavancin) and supplying its collaboration partner, Astellas Pharma US, Inc. (Astellas), with the launch inventory for the first commercial sale in the United States.
Astellas recently began notifying wholesalers that it is now accepting orders for VIBATIV in preparation for a commercial launch during the fourth quarter of 2009. On September 11, 2009, the FDA approved VIBATIV 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.
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