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Regeneron, Sanofi Take Step Forward With Cholesterol Drug

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The race for a new treatment is heating up. The companies say they are enrolling for a large clinical trial as Amgen prepares to release its own drug study results.

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MINYANVILLE ORIGINAL Highlighting their lead in a race to bring a new heart treatment to market, Regeneron Pharmaceuticals (NASDAQ:REGN) and partner Sanofi (NYSE:SNY) said Monday that they are enrolling 18,000 patients in a late-stage clinical trial to further test an injected drug aimed at lowering bad cholesterol known as LDL.

The drug, part of a new class of medicines, would treat people who can't lower their LDL (low-density lipoprotein) cholesterol by taking widely used statin medicines, like Pfizer's (NYSE:PFE) Lipitor, Merck's (NYSE:MRK) Zocor, or generic rivals. Regeneron and Sanofi are in a race with other companies, including Amgen (NASDAQ:AMGN), that also are trying to bring a new cholesterol-lowering medicine to market.

The drugs being studied by Regeneron, Sanofi, Amgen, and others are designed to block a human protein known as PCSK9, which can inhibit the liver from removing LDL from a patient's blood. High levels of LDL increase the risk of heart attacks and strokes. In earlier testing, the Regeneron-Sanofi drug taken with Lipitor was shown to reduce LDL levels by more than 70%.

Amgen will present data from four trials of its own drug candidate, AMG 145, Monday and Tuesday at a meeting of the American Heart Association in Los Angeles. Regeneron and Sanofi are scheduled to present their own data on Tuesday. Regeneron's drug is farther along in testing. However, there will be great investor interest in Amgen's results this week as a new treatment would be a boon to any drug company.

Millions of Americans can potentially be helped with an LDL-lowering drug, says Bill Sasiela, Regeneron vice president who heads the company's cardiovascular research.

A number of people taking statins are unable to lower their LDL and some patients can't take statins, especially at high doses, because of a muscle pain side effect. While Regeneron and Sanofi would aim to treat a broad patient population, those people who have a history of heart attacks or strokes would be a key group to target.

"The evidence generated to date, shows the more that you can lower LDL cholesterol levels, the lower the rate of heart attacks," Sasiela says in an interview with Minyanville.

Regeneron and Sanofi are partners who share in the cost of the research and also would share sales if the drug is approved. The companies would hope to file for US approval sometime in 2015, Sasiela says.

Analysts have said the drug could be another blockbuster for Regeneron. Last year, Regeneron won US approval for Eylea, a drug that treats a blinding disease in the elderly. Sales of that drug has been robust and Regeneron expects more than $800 million in revenue for 2012, the first full year of sales for the product.

Shares of Regeneron rose almost 160% this year, closing at $143.50 on Friday.

Sanofi and Regeneron are hosting a call with investors and analysts at 10:15 a.m. ET Monday. The call also is being webcast and can be accessed at either www.sanofi.com or www.regeneron.com.

Twitter: @brettchase

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No positions in stocks mentioned.
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