By Bloomberg News <\/p>\n
An experimental drug from Sanofi and Regeneron Pharmaceuticals Inc. lowered patients so-called bad cholesterol by as much as 72 percent on top of Lipitor in a company-funded study. <\/p>\n
(Last year, French drug maker Sanofi bought Genzyme Corp. of Cambridge for $20.1 billion.) <\/p>\n
The medicine, one in a class of drugs targeting the PCSK9 gene, reduced patients average LDL cholesterol levels to as little as 34 milligrams per deciliter after 12 weeks in the mid- stage study, presented today at the American College of Cardiology meeting in Chicago. Less than 100 mg\/dL is considered optimal for LDL, according to the Mayo Clinic. <\/p>\n
Its a wow study, said James McKenney, the trials lead investigator and chief executive officer of National Clinical Research, a Virginia-based company that runs studies. Instantly youre seeing all those patients you could not get to the level youd like for them to be at, now you have a medicine that unquestionably can. <\/p>\n
About 25 percent of US adults 45 and over take cholesterol-lowering statins, according to the National Center for Health Statistics. Statins include pills such as Pfizer Inc.s Lipitor, the worlds best-selling medicine in 2010 with revenue of $10.7 billion. Almost a third of statin users dont get enough of a benefit, leaving them more vulnerable to heart disease and in need of additional therapy, McKenney said in a telephone interview. <\/p>\n
The 183-patient trial, funded by Paris-based Sanofi and Tarrytown, N.Y.-based Regeneron, produced results reminiscent of the cholesterol-lowering advances achieved by statins two to three decades ago, McKenney said. Patients for whom statins work can see their cholesterol reduced by as much as 50 percent, lowering heart risks, he said. <\/p>\n
Amgen Inc., in Thousand Oaks, Calif., New York-based Pfizer, and Whitehouse Station, N.J.-based Merck & Co. are also developing treatments targeting PCSK9, said Chris Raymond, an analyst with Robert W. Baird & Co. in Chicago. The gene creates a protein that disrupts the ability of liver cells to remove bad cholesterol from blood, enabling it to accumulate. <\/p>\n
The study presented today evaluated five doses of Regeneron and Sanofis medicine, dubbed REGN727 or SAR236553, compared with a placebo. It found that 50 milligrams of the drug injected once every two weeks lowered LDL cholesterol by 40 percent, while 300 milligrams dosed every four weeks reduced LDL by 48 percent. The most-effective dose was 150 milligrams injected every two weeks, shown to lower LDL by 72 percent. <\/p>\n
Patients took Lipitor at doses of 10, 20, or 40 milligrams for at least six weeks before starting the study, and still had LDL levels higher than 100 mg\/dL. All groups continued taking Lipitor throughout the trial. Those on placebo -- Lipitor with no additional therapy -- had an LDL decline of 5 percent. <\/p>\n<\/p>\n
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