UPDATE 2-Theravance rises ahead of US drug review

(Adds stock movement, analyst comment)

NEW YORK, Nov 17 (Reuters) - Shares of Theravance Inc (THRX.O) gained nearly 7 percent on Monday after U.S. regulators released a preliminary analysis of the company's experimental antibiotic for serious skin infections.

Reviewers at the Food and Drug Administration said the drug, telavancin, appeared to fight complicated skin infections as well as an older antibiotic, but they also raised safety issues for discussion at a meeting of outside advisers on Wednesday.

The FDA staff noted nine deaths among people treated with telavancin, as well as nine deaths among others who were given the older drug, vancomycin. FDA reviewers determined some of the deaths were "possibly" related to telavancin, according to an analysis prepared for the panel.

Issues for panel discussion include possible harm to the kidneys and the potential for birth defects, the FDA staff said. Limb malformations were seen in animal studies of the drug.

Theravance, in a statement, said: "The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections."

In a summary prepared for the panel meeting, the company said telavancin would be an important new antibiotic because it showed the capability to fight potentially deadly bacteria that resist older antibiotics.

Theravance said "the only quantifiable risk is the development of (kidney) impairment."

"With appropriate consideration of the potential risks in individual patients and the use of (kidney) function monitoring in all patients, the benefits of telavancin outweigh the risks," the company said.

The FDA staff said they will ask the advisory panel if the data demonstrate the safety and effectiveness of telavancin for treating complicated skin infections, and whether the benefits outweigh the risks for pregnant women in certain situations.

"FDA appears headed in with an open-mind and, relative to prior investor expectations, maybe even a more positive bias on approvability, though these meetings themselves are inherently unpredictable," Robert W. Baird analyst Thomas Russo said in a research note.

The agency will make the final decision on whether to approve the drug. The FDA usually follows panel recommendations.

Theravance and Japan's Astellas Pharma Inc (4503.T) have agreed to collaborate on U.S. marketing of telavancin for the first three years.

Theravance shares gained 6.8 percent to close at $6.58 on Nasdaq. (Reporting by Lisa Richwine; Editing by Gerald E. McCormick,Maureen Bavdek and Gunna Dickson)