Vivus Races to Capture U.S. Approval of Obesity Drug

Includes: ARNA, OREX, VVUS
by: The Burrill Report

By Michael Fitzhugh

Shed weight. Keep it off. That's the promise of the experimental weight loss drug Qnexa, according to its developer, Vivus (NASDAQ:VVUS). Patients taking the biggest dose of Qnexa in a recent trial achieved and maintained an average loss of 26 pounds over two years with minimal side-effects, the California company says. Illustrating Qnexa’s safety and efficacy to the U.S. Food and Drug Administration is Vivus’ top concern as it races to dispel concerns about the drug’s risks and capture the first U.S. approval for a new weight loss drug in a decade.

Leland Wilson, Vivus’ CEO, says the new data offer “further reassurance” that Qnexa can help its target audience, obese and overweight people with co-morbidities such as high blood pressure, Type 2 diabetes, high blood fat levels, or abdominal fat.

In July, concerns about the drug’s safety led the majority of a panel of outside experts advising the FDA to recommend against approving the drug. They cited concerns about Qnexa’s potential impacts during pregnancy, psychiatric-related and cognitive-related adverse events, metabolic acidosis, and cardiovascular events.

The same panel, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, expressed safety concerns about one of Qnexa's competitors, Arena's (NASDAQ:ARNA) late-stage obesity drug lorcaserin. Orexigen's (NASDAQ:OREX) Contrave will be reviewed by the panel in December.

Although the agency often follows the committee’s recommendation, Canaccord Genuity analyst Adam Cutler expects a success for Vivus in this case.

“We view the two-year data from the SEQUEL study as highly supportive of approval,” he told investors in a September 22 research note. “In year two, Qnexa’s efficacy was largely maintained and the safety profile was confirmed,” Cutler says.

The FDA has said it will make a decision about whether or not to approve Qnexa by October 28, though it sometimes extends such deadlines to review additional data.

Final FDA decisions on Qnexa's top competitors are due soon too. The agency expects to decide whether or not to approve lorcaserin by October 22 and Contrave by January 31, 2011.