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Sanofi-Regeneron Cholesterol Drug Enters Late-Stage Trial

Sanofi and Regeneron Pharmaceuticals Inc. said they are enrolling patients in more than 10 late-stage clinical trials for a potentially first-in-class cholesterol-lowering drug targeting an enzyme called PCSK9.

The studies, dubbed Odyssey, will involve more than 22,000 patients, including 18,000 in a trial measuring cardiovascular outcomes such as heart attacks and strokes, Paris-based Sanofi and Tarrytown, New York-based Regeneron said today in a joint statement. The companies may apply for approval before the study is completed, based on how well the drug lowers LDL, so-called bad cholesterol, in other trials, said Regeneron’s Bill Sasiela.

The compound, known as SAR236553 or REGN727, is the furthest along in a class targeting PCSK9, involved in the increase of LDL. These therapies, also being developed by Amgen Inc., Pfizer Inc., Alnylam Pharmaceuticals Inc. and Roche Holding AG, target millions of patients who don’t benefit enough from cholesterol-lowering statins, such as Pfizer’s Lipitor.

“We’re very excited about this investigational treatment,” Jay Edelberg, head of Sanofi’s newly-created PCSK9 development and launch division, said in a telephone interview. “This is an opportunity to provide benefit to a broad number of patients, to reduce their LDL levels and their cardiovascular risk. This is our mission, this is why we’re here.”

In earlier studies, Sanofi and Regeneron’s experimental drug was shown to lower LDL by as much as 72 percent on top of Lipitor.

New Products

Sanofi is seeking to bring new drugs to the market as generic competition erodes revenue from best-selling products such as the Plavix blood-thinner. One in every six adult Americans suffer from high levels of the fat-like substance cholesterol, which builds up in the arteries and leads to heart disease, the leading cause of death in the U.S., according to the Centers for Disease Control and Prevention.

The trials will be conducted on people with elevated cardiovascular risk, or suffering from an inherited condition known as familial hypercholesterolemia, as well as in patients unable to tolerate statin therapy, the companies said.

Four of the trials have begun and others “will start quite imminently,” Edelberg said. If approved, Sanofi and Regeneron plan to begin selling the medicine in the fourth quarter of 2015 and make it available worldwide in 2016, he said. Patients will be able to inject the drug themselves through a single shot every two weeks.

Different Approach

Current treatments led by Pfizer’s statin Lipitor work differently. They are pills taken daily that work by blocking an enzyme the body needs to produce cholesterol in the liver. Almost one-third of statin users don’t get enough of a benefit, James McKenney, chief executive officer of National Clinical Research and lead investigator of an earlier trial of Sanofi and Regeneron’s drug, said in March when the data were reported.

“Statins were clearly revolutionary and probably the best class of drugs for a major disease since penicillin,” Henry Ginsberg, a professor at Columbia University Medical Center in New York and head of the Odyssey steering committee, said in a telephone interview. “This could be a revolution for people with very high levels of LDL cholesterol.”

Lipitor, which lost U.S. patent protection in November, generated $9.6 billion in worldwide sales in 2011.

As many as 3 million people in the U.S. may initially be eligible for the Sanofi-Regeneron therapy, should it be approved, said Robyn Karnauskas, an analyst with Deutsche Bank, in a May 29 research note. She estimates the drug may generate $3 billion to $6 billion in peak U.S. sales.

“A lot of patients out there, despite the available therapies, are not at goal,” said George Yancopoulos, Regeneron’s chief scientific officer, in a telephone interview. “It’s important to get these therapies to patients as soon as possible.”

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