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 ben.rubin@dowjones.com
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