Updated from 9:23 a.m. EST
rose Tuesday after the French pharmaceutical giant said a clinical trial shows its weight-loss drug Acomplia helps diabetics control blood-sugar levels.
The stock rose $1.13, or 2.6%, to close at $45.09 on trading that was four times greater than the average daily trade for the past three months.
Although Acomplia isn't available in the U.S., the drug was approved by the European Union in June. It is sold in a number of Western European markets for treating obesity and for helping overweight patients slim down.
Some analysts said the company would need more clinical-trial results to get regulatory approval for diabetes. The tests will determine effectiveness as well as safety. The drop-out rate in Tuesday's study due to side effects was 9.4% for patients receiving the drug vs. 2.1% for people receiving a placebo. The rate of "serious adverse events" was 6.5% for patients receiving Acomplia vs. 3.6% for patients taking the placebo.
Other studies are in progress. Tuesday's report is part of eight clinical trials worldwide, involving more than 22,000 patients to assess the drug's impact on diabetes and cardiovascular disease.
Acomplia, whose generic name is rimonabant, remains under review by the Food and Drug Administration
as a weight-loss treatment. The regulatory process has been slow due to FDA requests for additional data.
The FDA in February
granted conditional approval for Acomplia as a weight-management drug, but neither the agency nor the company has commented on the conditions. Sanofi-Aventis executives have been saying since late February that the FDA would act by year end.
The agency also rejected an application for Acomplia as a stop-smoking treatment. If Sanofi-Aventis wishes to pursue this use, it must conduct another clinical trial.
Sanofi-Aventis said Tuesday that diabetics who hadn't received other blood-sugar control medications did well with its drug vs. patients who received a placebo. The company-sponsored study was presented at a world diabetes conference in Cape Town, South Africa.
"This study suggests that rimonabant can achieve improvement in blood glucose with the added benefit of significant weight loss and improvement in other risk factors," said Dr. Julio Rosenstock, a clinical-trial investigator, in a company press release. Rosenstock is clinical professor of medicine at the University of Texas Southwestern Medical School in Dallas.
"We believe further data will be needed for Acomplia to get a diabetes indication," says Michael Leuchten, of UBS Securities, in a Tuesday report to clients. Leuchten, who has a neutral rating, doesn't own shares. His firm has had an investment-banking relationship within the last three years.
Leuchten adds that the higher rate of "depressed mood" in Acomplia patients vs. placebo-takers -- 5.8% vs. 0.7% -- will be "unhelpful for the company's discussions with the FDA." Other major side effects included nausea, a tingling sensation of the skin, dizziness, upper respiratory tract infection and anxiety.
The clinical trial, nicknamed Serenade, tested 278 patients at 56 medical centers in the U.S. and six other countries. The patients had Type 2 diabetes, in which the body doesn't produce enough insulin -- the protein hormone that helps convert sugar into energy -- or the body's cells don't adequately process insulin. Type 2 diabetes is the most common form of the disease; Type 1 diabetics cannot produce insulin naturally and must receive insulin injections.
People who received Acomplia had statistically significant reductions in blood sugar levels vs. people who received a placebo, according to the study, which tested people for six months. The company said more than half of the rimonabant patients achieved blood-sugar levels below the target set by the American Diabetes Association. These patients lost an average of 14.8 pounds while the placebo patients lost an average of 6 pounds.