Late Friday, biopharmaceutical company Theravance Inc. (THRX) and Astellas Pharma US Inc. announced that the U.S. Food and Drug Administration has approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant or MRSA and methicillin-susceptiblestrains or MSSA. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.
The companies noted that VIBATIV would be marketed and sold by Astellas and is expected to be commercially available in the United States during the fourth quarter of 2009. Theravance would collaborate with Astellas in marketing in the United States for the first three years following approval.
Ralph Corey, Professor of Medicine at the Duke University Medical Center and the principal investigator in the ATLAS program, said, "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."
VIBATIV, which was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA, is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Further, the company added that VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome"-like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
Also, use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma for the development and commercialization of VIBATIV worldwide except Japan. In July 2006, Theravance and Astellas expanded the collaboration to include Japan. As per the terms of the collaboration, Theravance is responsible for the development of and U.S. FDA filings for VIBATIV for the treatment of complicated skin and skin structure infections and nosocomial pneumonia.
Theravance is also responsible for the manufacture of about six months of first commercial sale stock for launch of VIBATIV in the United States. Astellas is responsible for all other development, regulatory, manufacturing, sales and marketing activities. Theravance would collaborate with Astellas in marketing in the United States for the first three years following approval.
THRX closed Friday's regular trading session at $18.20, down 18 cents or 0.98%. In the after-hours trading session, the stock traded at $19.00, up 80 cents or 4.40%.
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