Sanofi's multiple sclerosis pill Aubagio has been an also-ran behind established drugs like Teva's Copaxone and newer drugs like Biogen's Tecfidera. But the French drugmaker has not given up on it and today released data that might give it a new opening even as the MS market is shifting.
After a December flip-flop, the word from NICE on Sanofi's Aubagio is now final: The British cost watchdog has recommended the multiple sclerosis pill for use in Britain's National Health Service, tallying a victory for an MS franchise that has seen some recent ups and downs.
Sanofi intends to appeal the FDA's denial of Lemtrada, its multiple sclerosis drug that was a key reason it paid $20.1 billion to buy Genzyme two years ago. But will the company invest more money in the drug, given that after three more years of trials it will be far behind competitors?
Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.
The U.K.'s cost-effectiveness analysts aren't sure Sanofi's new multiple sclerosis pill is worth the price--even at a discount. In a new review, the National Institute for Health and Care Excellence found information on Aubagio wanting, and so it asked the French drugmaker's Genzyme unit for more.
Sanofi now has not one, but two, big multiple sclerosis launches to get under way in Europe. Two weeks after nabbing EU approval for its new MS pill Aubagio, Sanofi got regulatory clearance for Lemtrada.
Sanofi's Genzyme got a double dip of good news Friday for its expansion in the multiple sclerosis market. First Europe's drug regulator gave a nod to Lemtrada for treating the disease. Then, as a bonus, it gave a designation to Genzyme's potential blockbuster Aubagio that will keep its patent protected longer.
Biogen Idec's ($BIIB) newly approved Tecfidera has a wholesale price of $54,900 per year, the biotech giant revealed on Friday. With the U.S. market debut of the oral multiple sclerosis drug set for Monday, Biogen plans to hit the market for MS pills with a lower price than Novartis' ($NVS) Gilenya, which is arguably the company's top competition.
The European Medicines Agency's drug-review committee has recommended approval for Sanofi's new multiple sclerosis treatment Aubagio. But the EMA says it doesn't deserve "new active substance" status, because it's a revamped version of a much older drug. And that means Sanofi's monopoly would be severely limited.
Just days ahead of a big-time FDA decision on its oral multiple sclerosis pill, Biogen Idec grabbed the endorsement of a European Union authority for approval of Tecfidera as a first-line therapy.