Sanofi and Regeneron Pharmaceuticals Inc. (REGN)’s experimental treatment alirocumab lowered cholesterol three times more than Merck & Co. (MRK)’s Zetia in the first late-stage study of a drug that may garner $3 billion sales annually.
In a trial dubbed Odyssey Mono that involved 103 patients, alirocumab reduced levels of LDL, so-called bad cholesterol, by 47 percent after 24 weeks of treatment, compared with 16 percent among those receiving Zetia, the companies said in an e-mailed statement today.
Alirocumab has so far shown “an unprecedented reduction in LDL,” Jay Edelberg, the executive overseeing the drug’s development for Sanofi, said in a telephone interview. “It offers the promise of being able to get patients to and below their LDL targets. It would be a big deal for patients.”
The results give Paris-based Sanofi (SAN) the lead in a race with Amgen Inc. (AMGN), Pfizer Inc. (PFE) and Roche Holding AG (ROG) to be first to market with a new class of drugs called PCSK9 inhibitors. Sanofi and Regeneron aim to begin selling the medicine by the end of 2015 and to make it available worldwide in 2016, Edelberg said. Annual sales may total more than $3 billion by 2025, according to Alistair Campbell, an analyst at Berenberg Bank in London. That would help Sanofi replace revenue lost to generic competitors of its Plavix and Lovenox blood thinners.
“Sanofi believes it will be in a position to launch ahead of Amgen, but it is unlikely to be far ahead,” Campbell wrote in a Sept. 27 research report.
Sanofi won rights to alirocumab as part of an alliance with the Tarrytown, New York-based biotechnology company Regeneron, in which it owns a 17 percent stake. Sanofi Chief Executive Officer Chris Viehbacher said last month that increasing the holding to the 30 percent allowed under the companies’ partnership agreement “could well make sense.”
“How fast we do that, whether or not we do that, is a function of a number of different factors,” Viehbacher said during a Bank of America-Merrill Lynch conference on Sept. 13.
The results are the first from 12 trials of alirocumab on more than 23,000 patients. The largest test, Odyssey Outcomes, is designed to determine whether the treatment prevents fatalities from heart attack and stroke compared with a placebo.
Heart disease and stroke are the two biggest causes of death worldwide, accounting for almost 22 percent of deaths in 2011, according to the Geneva-based World Health Organization. The low-density lipoprotein, or LDL, form of cholesterol only comes from eating animal products, and it raises the risk of the two illnesses by clogging arteries, according to the American Heart Association.
“There’s a crying need here for more drugs,” George Yancopoulos, Regeneron’s chief scientific officer, said in a telephone interview. “So many people do not get to goal on statins alone or are intolerant of statins. There’s a real medical demand.”
Patients will be able to inject alirocumab themselves through a single shot every two weeks, Edelberg said.
The auto-injector device “is designed to make the experience as easy for the patient as possible,” he said. “It’s a small needle, the patient doesn’t see it.”
Alirocumab is a so-called monoclonal antibody designed to lower LDL cholesterol by targeting the PCSK9 enzyme that leads to higher levels of the fat in blood by preventing liver cells from processing the substance. Pfizer, Roche, Amgen and Alnylam Pharmaceuticals Inc. (ALNY) are also working on anti-PCSK9 treatments.
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’s Lipitor and AstraZeneca Plc (AZN)’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.
Zetia will be Whitehouse Station, New Jersey-based Merck’s second-biggest selling drug this year, with sales of $2.6 billion, according to analyst estimates compiled by Bloomberg.
More detailed results from alirocumab will be presented during a medical conference in 2014, Sanofi and Regeneron said.
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