Europe Denies Obesity Drug Approval

Health and Healthcare

Published: February 21, 2013 5:20 pm

If you are obese in Europe, you are not about to get a little pill to take to help you change. You will just have to lose that weight the old-fashioned way through diet, exercise, and lifestyle changes. VIVUS, Inc. (NASDAQ: VVUS) confirmed on Thursday evening that the European Medicines Agency’s Committee for Medicinal Products for Human Use stuck with its prior decision from October 18, 2012 against the approval of Qsiva to treat obesity.

VIVUS had requested a re-examination of the opinion after the first denial. The EMA again declined marketing authorization and the committee indicated that a pre-approval cardiovascular safety trial would be necessary to establish long-term safety. Qsiva is known in the United States as Qsymia and it was approved by the Food & Drug Administration in July 2012. The effect of Qsymia on cardiovascular morbidity and mortality has not been established, nor has its safety and efficacy as a combination treatment.

The company is expected to report earnings next week and estimates are for sales to be only about $3.1 million. Sales in the current quarter ending in March are for sales of $16.6 million with annualized 2013 sales protected to be $103.7 million (estimates from Thomson Reuters).

There are two closely watched obesity drug makers which often trade close to in-tandem with each other when news is out. Orexigen Therapeutics, Inc. (NASDAQ: OREX) closed down 5.8% at $5.30, and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) closed down 2.9% at $8.07.

VIVUS shares closed down 1.9% at $12.88 on the day and the after-hours reaction is down more than 3% at $12.16.

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