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Regeneron's Cholesterol Drug to Get a Closer Look

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The biotech's stock has more than doubled this year on success of an eye drug but an LDL-lowering treatment should begin attracting attention if study results hold up.

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Shares of Regeneron Pharmaceuticals (REGN) have more than doubled this year on a successful early sales launch of the company's drug Eylea to treat blindness in the elderly.

But a study to be presented Monday may give investors hope for a another potentially big drug from the company. Regeneron is presenting data from a study of a cholesterol-lowering therapy. The treatment, known as REGN727, is part of a new class of drugs aimed at lowering bad LDL cholesterol levels. These new drugs are considered promising as some patients can't lower LDL levels by simply taking statin medicines such as Pfizer's (PFE) Lipitor.

Regeneron and partner Sanofi (SNY) are in a race with a number of companies also working on new cholesterol drugs, including Pfizer, Amgen (AMGN), Merck (MRK), Bristol-Myers Squibb (BMY), Isis Pharmaceuticals (ISIS), and Alnylam Pharmaceuticals (ALNY).

But Regeneron is farthest along in its research and plans later this year to begin the last of three phases of studies usually needed to win US drug approval. If Monday's results are positive, investors should take note.

More than 70 million Americans have elevated levels of LDL, and almost half of them are receiving some sort of treatment, says Robert W. Baird analyst Christopher Raymond.

"A sizable market for an add-on therapy … clearly exists," Raymond says. Regeneron's drug is "emerging as an important value-driver" for the stock, he adds.

These drugs being studied by Regeneron and others seek to block a protein known as PCSK9. Early results have shown success in reaching their goals, including preliminary analysis released by Regeneron in November. REGN727 will be the focus of two presentations at the American College of Cardiology conference in Chicago, which begins this weekend. But the key presentation will be the so-called late breaker on Monday morning.

To be sure, Regeneron is years away from actually getting to the point where it would apply for US approval of its cholesterol drugs and there are plenty of things that can trip it up, such as safety issues. But Monday's results should at least give investors an early signal on the experimental treatment.

For the time being, the company continues to benefit from Elyea, which has exceeded expectations in its short time on the market. (See Regeneron Blows Away Sales Forecast for New Eye Drug.)

The company's stock fell almost 1% to $116.47 in late-morning trading Thursday. The shares are up 111% this year and 193% over the past 12 months.

Twitter: @brettchase

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No positions in stocks mentioned.
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