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Theravance, Inc. (THRX) announced the FDA Approval of 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.
VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance. It is the first lipoglycopeptide peptide approved by the FDA.
VIBATIV will be marketed and sold by Astellas Pharma USA, the Company's partner, and its 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.
Rick Winningham, CEO of Theravance, commented in a conference call today, "As a result of this approval and our supplying Atellas with inventory for the first commercial sales launch in the U.S., we will earn a $20 million milestone from Astellas."
He continued, "We believe there are significant opportunities for VIBATIV. Approximately 35% of total U.S. hospital treatment days active against MRSA are for patients with skin and skin structure infections."
Michael Aguiar, CFO of Theravance, noted, "We believe that the skin indications alone will be sufficient to get on hospital formularies, and a hospital-acquired pneumonia indication would just increase that adoption."
He added, "Product pricing has not yet been determined by us and Astellas, but we believe that pricing will fall within the approximate range of $150-$200 a day per patient."
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