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Sanofi, Regeneron's Anti-Cholesterol Drug Has Good Test Results

By Sten Stovall Of DOW JONES NEWSWIRES LONDON -(Dow Jones)- French drug maker Sanofi SA (SNY) and U.S. biotech Regeneron Pharmaceuticals Inc. (REGN) Thursday said their novel anti-cholesterol drug REGN727 produced positive preliminary results in mid-stage clinical tests. The experimental injectable therapy is designed to fight excessively high cholesterol, and belongs to a new class of medicines that could become the biggest weapon against heart disease since statins were introduced in the 1980s. They work by blocking PCSK9, a protein whose natural function is to preserve levels of "bad" LDL cholesterol in the bloodstream. Regeneron and Sanofi said their REGN727 drug reduced bad LDL cholesterol by between 30% and 65%, depending on dose, in one Phase II trial that lasted 12 weeks and produced no serious bad side effects from use of the drug. In another Phase II trial, REGN727 reduced bad LDL cholesterol by more than 65% after eight weeks' treatment. A third study of the Phase II program is ongoing. "The preliminary Phase II results with our anti-PCSK9 antibody are very encouraging," said Elias Zerhouni, head of global research and development at Sanofi. "We look forward to analyzing and presenting the complete data set and remain committed to advancing this program into Phase III development as soon as possible." Analysts say Sanofi and Regeneron now appear to have the lead in developing a drug that goes after PCSK9. Amgen Inc. (AMGN), Merck & Co. (MRK), Alnylam Pharmaceuticals Inc. (ALNY) and a partnership between Bristol-Myers Squibb Co. (BMY) and Isis Pharmaceuticals Inc. (ISIS) aren't far behind, however, with rival drugs of their own. The anti-PCSK9 medicines are expected to be used alongside statins, such as Pfizer Inc.'s (PFE) Lipitor and AstraZeneca PLC's (AZN) Crestor, for patients who don't achieve cholesterol-lowering goals with statins alone. They would also be used on their own for a much smaller group who cannot tolerate statins, which are oral drugs that inhibit the liver's production of LDL cholesterol. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected]

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