Orexigen Jumps on Diet Pill’s Heart Benefit as FDA Frowns

Updated on

Orexigen Therapeutics Inc. shares soared to their highest value in more than 18 months after the drugmaker said its diet pill Contrave had cardiovascular benefits. Regulators and the study’s researchers criticized the drugmaker for releasing the data, saying it wasn’t meant to be public.

Patients on Contrave had fewer major adverse cardiovascular events and cardiovascular deaths than patients on a placebo, Orexigen said. Those conclusions were based on early data from a study of 8,910 obese patients.

Orexigen won U.S. approval in September to offer the drug to weight-loss patients. The pill, to be used with a lower-calorie diet and exercise, is designed to reduce appetite and control cravings for chronic weight management.

“The observed effects on CV outcomes were unexpected and appear to be unrelated to weight change,” the La Jolla, California-based company said in a filing Tuesday, referring to the drug’s cardiovascular effect.

“We view the news as very significant,” said Simos Simeonidis, an analyst at RBC Capital Markets, in a note to clients. He rates the shares outperform. “The newly revealed data demonstrated that not only is Contrave safe to use from a CV standpoint, but it actually appears to have a CV benefit.”

Orexigen shares advanced 32 percent to $7.64 at the close in New York. Through yesterday’s close, the company’s stock had dropped 4.5 percent this year.

‘Strictly Forbidden’

The interim data were shared with a small group of Orexigen staff under terms that would allow “strictly limited use of the data,” said Steve Nissen, the trial’s lead investigator at the Cleveland Clinic, in an e-mail. “Public disclosure of these incomplete data or use of data for business purposes was strictly forbidden by the agreement.”

A blogger for Forbes, Larry Husten, reported on Nissen’s criticism earlier Tuesday.

Orexigen said it used the data to file for a patent. After the U.S. Patent and Trademark Office published the patent today, the drugmaker “believed it was appropriate and necessary to make sure this information was equally available to all investors,” according to a statement.

The U.S. Food and Drug Administration said that by disclosing the early results, Orexigen could affect the outcome of the remainder of the trial, since patients in the study could get access to the results. The agency has asked Orexigen to run a second cardiovascular outcomes trial, the FDA said in an e-mail.

While the FDA is “reassured by the interim data that Contrave is unlikely to increase the risk of cardiovascular events by more than twofold compared with placebo, FDA considers these preliminary data far too unreliable to conclude anything further about the cardiovascular safety of Contrave,” the agency said.

The second trial is expected to start later this year with results by 2022, Orexigen said.