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Sanofi - Regeneron antibody improves statin therapy in phase II

REGN727 binds to PCSK9, a new target for lowering LDL cholesterol

An antibody therapy in development at Sanofi and Regeneron Pharmaceuticals has generated positive results in phase II studies, providing additional reductions in LDL cholesterol even on top of treatment with statins.

REGN727 is a fully-human antibody that binds to PCSK9, a new target for lowering LDL cholesterol, which is the leading risk factor for coronary artery disease.

The phase II trial compared the antibody to placebo on top of standard treatment with statins, sometimes including cholesterol absorption inhibitor ezetimibe, in patients with heterozygous familial hypercholesterolaemia, an inherited form of high cholesterol. Interim results from the 20-week study showed that REGN727 reduced LDL cholesterol by 30 per cent to 65 per cent, compared to just 10 per cent with placebo.

A second study in patients with primary hypercholesterolaemia found that switching patients on low-dose atorvastatin (Pfizer's Lipitor) to REGN727 plus a high dose of atorvastatin achieved a 65 per cent-plus reduction in LDL cholesterol, compared to 17 per cent for high-dose atorvastatin alone.

"This is an antibody that ourselves and our partners as well as others in the pharmaceutical and biotechnology industry are extremely excited about," said Regeneron's vice president for strategy, Michael Aberman, at the Credit Suisse Annual Healthcare Conference yesterday.

While questions have been raised about the value of having another class of lipid-lowering agents, Aberman pointed out that 10 million patients in the US alone are unable to meet their LDL cholesterol targets despite the availability of statins. Moreover, LDL cholesterol target keep moving lower "as the data become clear that lower LDL cholesterol is better".

"We think there is a big market opportunity for patients who aren't able to achieve their goal on existing therapies," he added, noting that Sanofi and Regeneron aim to start a phase III programme for the antibody in the first half of 2012.

REGN727 was discovered as part of a $160m-a-year collaboration between Sanofi and Regeneron designed to fund pre-clinical research into new antibody-based drugs and feed drug candidates into the clinical pipeline. A total of eight antibodies have entered the clinic so far under the terms of the alliance, which runs until 2017.

10th November 2011

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