(This article was originally published earlier Wednesday.)
By Joseph Walker
An experimental drug being developed by Regeneron Pharmaceuticals Inc. (REGN) and Sanofi SA (SNY, SAN.FR) significantly reduced patients' cholesterol in a small late-stage study, one of a dozen clinical trials the company is conducting to gain regulatory approval for the treatment.
Patients taking the drug, called alirocumab, had their cholesterol reduced by an average of 47% over nearly six months, compared with a 16% decline in patients receiving ezetimibe, a drug marketed as Zetia by Merck & Co. (MRK). The study included 103 patients with moderate cardiovascular risk who weren't recommended by their physicians to take statins, the most effective and commonly used cholesterol-lowering treatments now on the market.
The results are consistent with earlier stage studies and still need to be confirmed in multiple trials of different patient populations before the companies will seek regulatory approval, said Regeneron President and Chief Scientific Officer George D. Yancopoulos. The companies are aiming to file for approval with the U.S. Food and Drug Administration toward the end of 2015, he said, with a possible approval coming in 2016.
Regeneron and Sanofi are among a handful of companies, including Amgen Inc. (AMGN) and Pfizer Inc. (PFE), developing new cholesterol-fighting treatments that suppress a protein called PCSK9 that makes it difficult for the body to clear LDL--low-density lipoprotein, known as bad cholesterol--from the blood. The drugs could be used in addition to statins by patients with stubbornly high LDL levels and in patients such as those in the Regeneron study who can't tolerate statins.
"This is the first phase-three study from any program that is going to be used for [approval]," said Dr. Yancopoulos in an interview. Alirocumab "has the chance of showing a tremendous amount of clinical benefit to the general population."
In the study, 69% of patients receiving alirocumab experienced side effects, compared to 78% of patients receiving ezetimibe. The most side effects were infections--including influenza and upper respiratory tract infection--which occurred in 42% of patients receiving Regeneron and Sanofi's drug, compared to 39% in the control arm.
If approved, PCSK9 treatments could represent significant sales for the drug industry, according to analysts. Regeneron and Sanofi's drug could reach $717 million in annual sales by 2017, according to projections from Robert W. Baird & Co. Amgen's treatment AMG145 is projected to reach $695 million by that time.
However, because the treatments are administered through twice-weekly or once-monthly injections and will have a high price tag, many physicians could be reluctant to prescribe the new therapies until large, long-term studies prove their benefit reducing in heart attacks and strokes.
Write to Joseph Walker at Joseph.Walker@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 16, 2013 07:49 ET (11:49 GMT)Copyright (c) 2013 Dow Jones & Company, Inc.
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