Analyst: FDA Won't Pull Permit On Orexigen Therapeutics

Orexigen Therapeutics, Inc. OREX sole product, the anti-obesity drug Contrave, almost certainly won't get pulled from the market, an analyst said Friday

Orexigen shares fell 12 percent Friday after a regulatory official threatened sanctions on the company for prematurely disclosing data from a drug trial. The official also called the data unreliable.

RBC's Simos Simeonidis, who maintained an Outperform rating on Orexigen, said it's "highly unlikely" that sanctions would include withdrawal of marketing approval for Contrave.

The official, John Jenkins of the Food and Drug Administration, also said the prematurely disclosed data suggesting that Contrave afforded benefits to cardiovascular patients represent "a highly unlikely, random-chance finding."

The disclosure of the supposed heart benefit Tuesday sent Orexigen shares up 50 percent.

Simeonidis said it's probable that cardiovascular benefits seen in the interim data will diminish as the study progresses.

But such an outcome "would not put the drug's regulatory status in any jeopardy," according to Simeonidis.

Contrave, developed in partnership with Takeda Pharmaceutical Co Ltd. TKPYY, got approved last year as a weight-loss treatment.

"The most likely scenario is that nothing really material comes of this, other than short-term volatility," Simeonidis said.

Potential sanctions on Orexigen, according to Jenkins, who heads the FDA's Office of New Drugs, range from imposing financial penalties to withdrawing Contrave from the market.

Data disclosed Tuesday, in an Orexigen filing concerning a patent application, concerned a long-term study aimed at determining whether use of Contrave posed cardiovascular risks.