Sanofi (SAN) and Regeneron Pharmaceuticals Inc. (REGN)’s cholesterol drug cut levels of the artery-clogging protein in nine trials, and reduced the rate of heart attack, stroke and death in one test, as the companies race with Amgen Inc. (AMGN) to get a new treatment to market.
In trials involving about 5,000 patients, alirocumab met the main goal of lowering bad cholesterol after 24 weeks of treatment more than placebo or drugs such as Merck & Co.’s Zetia, the two companies said in a statement today without disclosing detailed results. The drop was consistent with previous trials, such as one reported in October in which alirocumab lowered bad cholesterol by 47 percent, they said.
Sanofi is locked in a race with Amgen to be first to market with a new class of drugs called PCSK9 inhibitors that are designed to mimic a rare genetic condition in which about 3 percent of people naturally have extremely low cholesterol levels. Sanofi and Regeneron aim to apply for regulatory approval in the U.S. and Europe by the end of this year.
“We look forward to potentially providing a new treatment option for patients who may need a more aggressive cholesterol-lowering treatment on top of standard of care,” Elias Zerhouni, Paris-based Sanofi’s head of research and development, said in the statement.
Sanofi, which reports second-quarter earnings tomorrow, rose 0.1 percent to 76.89 euros in Paris. Regeneron climbed 6 percent to $322.76 as of 12:50 p.m. in New York. Tarrytown, New York-based Regeneron also said today it received U.S. approval for its eye drug Eylea for treatment of diabetic macular edema.
In one trial dubbed Odyssey Long Term involving 2,341 patients, an interim analysis showed patients taking alirocumab had a lower rate of death, heart attack, stroke and hospitalization from angina than those getting placebo. The two companies said they will present more data from the trials at a medical meeting.
The results from that trial are a “major positive” that may give Sanofi and Regeneron a competitive advantage over Amgen, analysts lead by Robyn Karnauskas at Deutsche Bank AG in New York wrote in a note today.
Alirocumab may garner sales of 773 million euros ($1.04 billion) by 2019, according to the average of four analyst estimates compiled by Bloomberg.
Amgen said yesterday it would seek approval for its PCSK9 inhibitor, evolocumab, in the U.S. and E.U. during the third quarter this year. Recent trials showed the drug cut levels of bad cholesterol by 55 percent to 66 percent.
Heart disease and stroke are the two biggest causes of death worldwide, accounting for about 25 percent of deaths in 2012, according to the Geneva-based World Health Organization. The low-density lipoprotein, or LDL, form of cholesterol raises the risk of the two illnesses by clogging arteries.
Alirocumab is designed to lower LDL cholesterol by blocking the PCSK9 enzyme. PCSK9 prevents liver cells from processing LDL cholesterol, leading to higher levels of the fat in blood.
The drugs are being developed for patients who can’t take or aren’t helped enough by statins, a class of cholesterol-lowering medicines that includes Pfizer Inc.’s Lipitor and AstraZeneca Plc’s Crestor. About 12 million people in the U.S. and 21 million worldwide don’t achieve the recommended reduction in LDL cholesterol with statins, according to a Sanofi presentation last year.
Sanofi won rights to alirocumab as part of an alliance with Regeneron, in which it owns a 22 percent stake. Sanofi Chief Executive Officer Chris Viehbacher said last year that increasing the holding to the 30 percent limit allowed under the companies’ partnership agreement “could well make sense.”
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