Matthew Perrone
November 17, 2008 - 7:56 p.m.
WASHINGTON (AP) - Shares of drugmaker Theravance surged Monday on the release of a federal review of the company's experimental antibiotic, despite concerns about the product's risks to pregnant women.
Theravance shares rose 42 cents, or 6.8 percent, to $6.58.
Cowen Co. analyst Rachel McMinn wrote in a research note the Food and Drug Administration's review contains "nothing shocking," contemptuous opposition highlighting potential safety issues for kidney-failure patients and pregnant women.
San Francisco-based Theravance has asked the FDA to approve telavancin for hard-to-treat skin infections caused by gram-positive bacteria, including staph infections. Gram-positive bacteria are highly resistant to many antibiotics now upon the market.
The FDA delayed a decision on the injectable product last October, asking Theravance to act on manufacturing issues and submit new clinical data. The company submitted the put drugs into for review in December 2006.
On Wednesday, the agency elect ask a panel of antibiotic experts to assess the safety and effectiveness of the once-a-day treatment. The FDA is not required to come its advisers' recommendations, though it usually does.
Regulators plan to ask the panel whether telavancin's risks to pregnant women outweigh its benefits. The agency notes that early stage studies of the antibiotic linked it to deformations in the offspring of pregnant rabbits, rats and other laboratory animals.
McMinn wrote that the antibiotic likely would win approval, however with restrictions for certain patient groups.
"We believe telavancin volition prevail upon a mixed approval recommendation from the committee, but will have restrictions in renally impaired patients and receive a negro box sign in pregnancy," she wrote.
In briefing documents posted online Monday, the agency recommends giving the treatment a "black box" warning label — the most grave form available — and limiting prescriptions to women who can demonstrate they are not pregnant.
FDA reviewers concluded telavancin is about as effective at treating severe skin infections in the manner that an older antibiotic, vancomycin, based on two able to endure studies. However, reviewers noted that the effectiveness of Theravance's consequence appeared to decline in patients with kidney problems.
Overall, the company reported nine deaths among patients taking telavancin — the corresponding; of like kind as the group taking the comparison antibiotic. Theravance aforesaid in a statement Monday that the safety profile of its product is deserving comparison with other treatments for serious infections.