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Next big cholesterol drugs on the way?

A possible revolutionary way to fight cholesterol is expected to cause a big stir among thousands of heart doctors gathering in Chicago starting this weekend for the annual American College of Cardiology meeting.

The new drugs in development by top pharmaceutical makers and up-and-coming biotechs are injectable medications that block a protein called PCSK9.

They have shown promise in early clinical trials for slashing "bad" LDL cholesterol further than widely used statins can alone. Their biggest advocates say PCSK9 blockers have the potential to be the next multibillion-dollar class of heart drugs.

Regeneron Pharmaceuticals Inc last year disclosed that its product slashed levels of LDL cholesterol up to 65 percent beyond reductions seen alone with statins - pills like Pfizer Inc's Lipitor and AstraZeneca Plc's Crestor that are today's standard treatments.

The company on Monday will unveil full trial results, including safety findings - giving a fuller picture of its potential and how widely it might be prescribed if approved.

Wall Street has followed the drug, called REGN 727, as well as rival products from Amgen Inc, Merck & Co and other drugmakers that are nipping at its heels. But relatively few doctors know much about the emerging new class of treatments.

"I can't believe the cardiologists won't be in awe of the LDL reductions" seen for Regeneron's drug, said Mani Mohindru, an analyst with Think Equity. She speculated the medicine, being developed in partnership with French drugmaker Sanofi, could generate huge sales if it succeeds in larger trials and remains free of serious safety concerns.

Regeneron is best known for its drug Eylea, approved to treat a leading cause of blindness called macular degeneration. Company shares have more than doubled to the $115 range since the injectable medicine, which competes with Roche Holding AG's Lucentis, was approved by U.S. regulators in November.

Mohindru said Regeneron shares could jump another $5 or more, to new lifetime highs, after the REGN 727 study is presented on Monday in Chicago.

"It will be a significant event because a lot of cardiologists haven't seen this data," she said. "And Wall Street still doesn't appreciate how wide a use the drug could have. It's not in Regeneron's stock in a big way, so there's upside here."

Amgen on Sunday will present data from a study of its anti-PCSK9 medicine, called AMG145. Although it is an early-stage trial involving relatively few patients, compelling effectiveness and safety data might allow it to steal some of the Regeneron product's thunder.

"PCSK9 is one of the most exciting targets in cardiovascular drug development today," Michael Severino, Amgen's chief medical officer, said in an interview.
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