Isis, Genzyme: CHMP Issues Negative Opinion on Cholesterol Drug

   By Ben Fox Rubin 
 

Isis Pharmaceuticals Inc. (ISIS) and Genzyme, a Sanofi (SNY, SAN.FR) business, said the Committee for Medicinal Products for Human Use adopted a negative opinion for its marketing authorization of the cholesterol drug Kynamro, a setback for the treatment.

Isis shares dropped 10% premarket to $8.61, while Sanofi's American depositary shares were up five cents at $46.95.

Kynamro is a treatment for homozygous familial hypercholesterolaemia, a disorder of high levels of bad cholesterol that is passed down through families. The condition begins at birth and can cause heart attacks at an early age, according to the National Institutes of Health.

Genzyme said it plans to request a re-examination of the opinion. The committee, also known as CHMP, is part of the European Medicines Agency.

"We are disappointed by the committee's recommendation," Genzyme Chief Executive David Meeker said. "This is a rare disease patient population, with a life-threatening condition, in need of new therapies. We will work closely with the CHMP during the re-examination process to address the committee's concerns, with the goal of making this important medication available to HoFH patients in Europe."

An application for Kynamro is currently under review by the U.S. Food and Drug Administration. In October, the drug received a positive vote by an FDA advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of the treatment.

Write to Ben Fox Rubin at [e-mail]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires