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Theravance Says FDA to Review Telavancin
Thursday December 27, 5:22 pm ET
Theravance Says FDA Committee May Soon Review Injectable 'Superbug' Drug Candidate Telavancin
SOUTH SAN FRANCISCO (AP) -- Theravance Inc. said Thursday a Food and Drug Administration committee may meet soon to review telavancin, the company's once-daily injectable antibiotic for the treatment of skin infections caused by "superbug "bacteria.
Telavancin is designed to treat complicated skin infections, or cSSSI, that are often resistant to common antibiotics and are caused by staph infections.
The drug candidate has run across some hurdles.
In October, biopharmaceutical company Theravance said it received an FDA "approvable" letter for telavancin. The letter asked Theravance to resolve issues related to good manufacturing practices compliance at a third-party manufacturer and to submit revised labeling and additional clinical data, or reanalyze clinical data, before the drug could be approved.
Theravance and partner Astellas at that time said they believed no additional clinical studies would be needed to respond to the letter.
In November 2005, Theravance partnered with Astellas Pharma Inc. to develop and market telavancin worldwide except in Japan, and in July 2006, expanded the partnership to include Japan. Theravance will lead the development of telavancin for the treatment of cSSSI and hospital-acquired pneumonia, and will collaborate with Astellas in marketing in the United States for the first three years.
Shares of Theravance dropped $3.30, or 15.5 percent, to $18 in aftermarket trading, having closed earlier down 40 cents at $21.30. |
