Sanofi’s Aubagio Wins Final Approval From U.K. Cost Agency NICE

Sanofi’s multiple sclerosis drug Aubagio won final approval from the U.K.’s health-cost agency, allowing access to a market in which it will compete with Novartis AG’s (NOVN) Gilenya.

The National Institute for Health and Care Excellence, or NICE, recommended Aubagio, also known as teriflunomide, as a treatment option for adults with relapsing-remitting multiple sclerosis, the most common form of the disease, it said in a statement today. The decision confirms a preliminary ruling made last month in which NICE recommended the drug after Paris-based Sanofi agreed to a price cut.

The drug is the second oral MS treatment to win NICE’s backing in the U.K., after Basel, Switzerland-based Novartis’s Gilenya was approved in April 2012. Aubagio is the only oral MS drug to demonstrate an ability to slow the progression of disability in two trials, William Sibold, the head of MS at Sanofi’s (SAN) Genzyme unit, said in a telephone interview.

“That consistent efficacy is something that resonates very well with the community,” Sibold said.

Aubagio has “blockbuster potential,” Sibold said, without providing a specific sales forecast. The drug may reach sales of 647 million euros ($876 million) in 2018, according to the average of eight analyst estimates compiled by Bloomberg.

Sanofi plans to target the 80 percent of MS patients who use injectable treatments, he said.

The decision means Britain’s National Health Service is obliged to begin paying for the drug within three months, NICE said. Aubagio will come with a list price of 1,037.84 pounds ($1,709) per 28-tablet pack, NICE said, without disclosing the level of the discount.

To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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