UPDATE 2-Isis to delay cholesterol drug data; shares drop
(Recasts; adds comments from analysts and companies, background; updates share movement)
By Esha Dey
BANGALORE, April 25 (Reuters) - Isis Pharmaceuticals ISIS.O will delay submitting final results from a late-stage study of its cholesterol drug after U.S. health regulators asked for additional cancer-related data from two preclinical trials, sending its shares tumbling 30 percent.
Isis and co-developer Genzyme Corp GENZ.O expect to submit final data from the ongoing late-stage trial of the drug, mipomersen, in 2010. Earlier, submission was expected in 2009, Isis spokeswoman Amy Blackley said.
"It is clear that the time line has shifted significantly to the right and development risk and expense have increased," Leerink Swann analyst Joseph Schwartz said in a note to clients. Schwartz kept a "market perform" rating on Isis.
Mipomersen reduces the production of a protein critical to the synthesis and transport of low-density lipoprotein (LDL) or "bad" cholesterol.
The companies are studying the drug in patients with a rare genetic disorder, known as familial hypercholesterolemia (FH), characterized by high "bad" cholesterol.
The clinical studies are being held for two types of FH, homozygous and heterozygous. The U.S. Food and Drug Administration said that reduction of low-density-lipoprotein (LDL)-cholesterol is an acceptable "surrogate endpoint" for accelerated approval of mipomersen in patients with homozygous FH, Isis said.
The drug meeting the "surrogate" goal of reducing LDL-cholesterol levels would not be sufficient to get an approval, Leerink Swann's Schwartz said by phone. "You need hard outcome," he added. Continua...