Sanofi ($SNY) finally has its FDA approval for Lemtrada. The multiple sclerosis drug, previously rejected by the agency, will hit the market after a trio of new oral treatments. It will come with a boxed warning and faces tight controls on prescribing and distribution.
But if the company can persuade payers that it's worth $158,000 per two-treatment regimen, Lemtrada could still climb its way to blockbuster sales. Analysts are expecting a slow ramp-up, with $400 million in sales by 2018 and $1 billion by 2021.
As the latest MS drug to hit the market, Lemtrada follows some big new launches. Biogen Idec's ($BIIB) oral med Tecfidera brought in almost $2 billion for the first 9 months of 2014, its first full year on the market. Gilenya, launched by Novartis ($NVS) in 2010, delivered $1.8 billion for the first 9 months, up 29% year over year. Sanofi's own pill, Aubagio, hasn't gained as much traction, with $378 million in sales for the same period.
As a long-acting biologic treatment, however, Lemtrada will be playing in a different market. It's approved as a third-line therapy, after patients have failed on two previous meds. And rather than injections daily or weekly or even twice a month, Lemtrada will be infused in two treatment courses, the first for 5 days straight, and the second 12 months later, for three days.
Its head-to-head rival, Rebif, is administered in a similar fashion for $135,000. It's a long-standing blockbuster for Merck KGaA with $2.5 billion in 2013 sales. And here's where Sanofi's sales pitch comes in. Lemtrada was tested against Rebif in two trials, with one showing fewer relapses in Lemtrada patients, and the other showing fewer relapses and less progressive disability, Sanofi says. For 70% of patients, no further infusions were required over a three-year period; the drug's effects can last for up to 5 years.
That's the data Sanofi will be touting with payers. And on that note, the FDA delay may have been a plus. To change the agency's mind, Sanofi not only handed over a new analysis of trial data the agency initially questioned, but also delivered more efficacy data. And the argument worked well enough for the notoriously picky cost-effectiveness watchdogs in the U.K., which backed Lemtrada earlier this year.
But doctors may be wary of such a long-lasting treatment. "You write a prescription for 5 years and you can't take it back," Columbia University MS expert Claire Riley told The Wall Street Journal. "From a physician standpoint, it gives you pause."
|Genzyme MS chief Bill Sibold|
Clearly, Sanofi has work ahead to build demand for Lemtrada. But at least it finally has the opportunity to try. "About 60% of the global market for multiple sclerosis is in the U.S.," Genzyme's MS chief, Bill Sibold, told The Boston Globe. "We talk about our aspirations to be leaders in MS. Up until this point, we've had Aubagio, which we're very proud of. But this will give us both products for our U.S. franchise."
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