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Regeneron and Sanofi cholesterol drug shines in phase II

Amgen also presents positive early data for its own PCSK9 inhibitor at American College of Cardiology meeting

Regeneron and Sanofi's monoclonal antibody drug REGN727 has achieved impressive reductions in blood cholesterol levels in patients who are not adequately treated using statins.

The phase II results - presented at the American College of Cardiology annual meeting in Chicago - showed that a once-monthly subcutaneous injection with REGN727 reduced LDL cholesterol (LDL-c) by 40-72 per cent among patients who had elevated levels despite a stable dose of statins.

The drug is in a new class of PCSK9 inhibitors, a group which includes rival antibody AMG 145 from Amgen and early-stage candidates from Bristol-Myers Squibb and Merck & Co.

The class has been attracting considerable attention as another treatment option for statin-intolerant patients and those with a genetic predisposition to high LDL-c that resists drug therapy, with analysts predicting possible collective peak sales of $20bn a year, according to a Reuters report.

"Many patients are not able to lower their LDL-c sufficiently by diet and medication despite the availability of statins," commented Dr James McKenney of the Virginia Commonwealth University School of Pharmacy, who was the study's principal investigator. "As guidelines are evolving, there is a real need for additional lipid-lowering medications," he added.

Cardiologists at the ACC were cautiously optimistic about the prospects of the PCSK9 inhibitors, but warned that the potential of the class is still speculative in the absence of trials with hard, clinical endpoints.

Regeneron and Sanofi are now planning to move ahead with a phase III programme for REGN727 in the second quarter of 2012.

Meanwhile, a phase I trial of Amgen's AMG 145 was also presented at the ACC meeting, showing that it cut LDL-c by more than 60 per cent after two once-monthly injections.

There was considerable debate at the meeting about the likely dosing schedule for the two drugs, with some suggestions that a tapering off of REGN727's effects meant that it would probably have to be dosed every two weeks, rather than once a month.

That could confer an advantage to Amgen if its later studies continue to support once-monthly dosing, although Steve Nissen of the Cleveland Clinic told Reuters he did not believe dosing frequency would be a major factor in treatment selection.

27th March 2012

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