By Bill Berkrot
NEW YORK (Reuters) - Schering-Plough Corp (SGP.N: Quote, Profile, Research, Stock Buzz) has one of the most successful new cholesterol drugs on the market, but its chief executive is proceeding with extreme caution before committing to developing medicines to raise "good" HDL cholesterol.
Drugs that lower "bad" LDL cholesterol -- including Vytorin, which is sold by Schering-Plough in a joint venture with Merck & Co Inc (MRK.N: Quote, Profile, Research, Stock Buzz) -- are the world's top selling prescription medicines.
HDL-raising drugs have been among the hottest new areas of drug research and cardiologist interest, but Schering-Plough has thus far remained on the sidelines.
"I still think that the area needs to be looked at very carefully," Schering-Plough CEO Fred Hassan said at the Reuters Health Summit in New York on Tuesday.
"If there's a way we can probe the area and prove to ourselves that it's a safe approach, then we will go after it," Hassan said.
New research has convinced Hassan of the health benefits of raising HDL levels in the blood, but just how to go about it remains the critical question.
"One has to be careful. New concepts always carry a lot of risk," Hassan said.
"When it comes to HDL there are many different kinds of HDL. How you elevate HDL is very important," he added.
"We know that niacin has some beneficial effects on HDL but it's not very clear that the beneficial effects of niacin are only because of HDL. There may be other beneficial effects that are not fully understood," Hassan said.
One innovative new method of HDL raising, known as CETP inhibition, proved a costly failure for Pfizer Inc (PFE.N: Quote, Profile, Research, Stock Buzz) last year, when it halted development of its most important experimental drug after a large, late-stage study turned up increased deaths in those taking the medicine, torcetrapib.
Other companies, including Merck and Roche Holding AG (ROG.VX: Quote, Profile, Research, Stock Buzz) are still pursuing CETP inhibitors with the hope that the problems Pfizer found were specific to torcetrapib and not the new class of medicines as a whole.
"The fact that there was a mortality difference in the Pfizer trial should make us cautious about this category of molecules. I think there's a bigger hurdle now than would have been the case had the Pfizer drug not had the problem," Hassan said.
Hassan believes the U.S. Food and Drug Administration will insist on so-called outcomes trials before considering approving such a drug. That means large, expensive studies to prove that a drug is not only effective, but that it does not increase heart attacks, strokes or death.
"We're looking at (HDL-raising drugs) very aggressively," Hassan said. "But we are not necessarily in the CETP inhibitor space because we are now very cautious in that area."
(For summit blog: summitnotebook.reuters.com/)
(Editing by Jeffrey Benkoe)
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