* Drug designed to treat bleeding in the esophagus
* Panel voted 14-0 benefits not shown to outweigh risks
* Salix shares fall 2.4 percent (Adds panelist, company comments; updates shares)
SILVER SPRING, Md., - A U.S. advisory panel on Tuesday rejected a Debiovision Inc drug after members said the company lacked enough evidence to show it was effective for treating a dangerous type of bleeding in the esophagus.
The Food and Drug Administration advisory committee voted 14-0 that currently available data failed to show the benefits of the drug, Sanvar, outweighed risks.
Salix Pharmaceuticals (SLXP.O) holds U.S. marketing rights for the medicine. Salix shares fell 2.4 percent to close at $9.81 on Nasdaq.
Panel members shared concerns voiced by FDA reviewers that Debiovision's most recent study had limitations, including the lack of a control group. The company compared the results with patients who received a placebo in an earlier trial.
Some panelists felt "there was some small level of improvement" shown mainly in one study, "but it's been complicated by the other studies that we can't completely interpret," said Dr. Lin Chang, the committee's chairwoman and co-director of the UCLA Center for Neurovisceral Sciences and Women's Health.
Earlier, the committee voted 13-1 that Debiovision did not provide substantial evidence of the drug's effectiveness.
Panel members also said it was hard to tell if the drug contributed to serious problems including an abnormally slow heart beat and low blood platelets that were sometimes fatal. The panel was "not sure if they're due to the drug or (patients') chronic conditions," Chang said.
The FDA will consider the advice as it decides whether to clear sales of Sanvar, known generically as vapreotide. A ruling is due by July 1, although the agency has missed several drug review deadlines in recent months.
BMO Capital Markets analyst Robert Hazlett estimates peak sales of $50 million for Sanvar if it reaches the market.
Before the votes, Debiovision argued that Sanvar helped control esophageal bleeding that can develop from liver cirrhosis, which reduces blood flow to the liver and diverts the blood to tiny vessels lining the esophagus. The vessels can swell and burst, causing potentially fatal complications.
About 30,000 people in the United States will develop the condition, known as esophageal variceal bleeding, in 2009, the company said. Standard therapy involves putting a tube down the throat to seal the blood vessel, but it does not always work.
Debiovision told the panel its research showed adding intravenous Sanvar helped control bleeding, and the risks were similar whether patients were given the drug or a placebo.
Company officials also said doctors were using another drug, octreotide, that is not cleared for treating esophageal bleeding and that patients would be better served by an approved treatment. Octreotide is sold generically and by Novartis AG (NOVN.VX) (NVS.N) under the brand Sandostatin.
"Because of proven efficacy, lack of serious side effects and excellent tolerability, (Sanvar) has a favorable benefit/risk ratio," said Marco Petrella, Debiovision's director of clinical affairs and new product development.
Responding to an earlier application in 2004, the FDA said Sanvar was "approvable" but sought more evidence of effectiveness. The company said the FDA had approved the trial design that the agency reviewers and the panel criticized.
FDA reviewers said it was difficult to interpret the findings, however, because the standard treatment of esophageal bleeding had improved since the company's earlier research.
Debiovision is a unit of privately held Swiss pharmaceutical company Debiopharm.
