Back in 2011, when Sanofi acquired Genzyme for about $20 billion, it promised the company's shareholders up to $3.8 billion more tied to the then-in-development multiple sclerosis treatment Lemtrada. Things went awry in 2013 when the FDA rejected the therapy, but a new shareholder lawsuit claims that's just what Sanofi wanted.
Biogen, Sanofi and Novartis are all touting new data showing long-term benefits for their respective meds at this year's European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting--and with tough new competition on the way, they may need it.
Sanofi's Genzyme has found a silver lining to last winter's FDA snub of Lemtrada. For starters, Genzyme is fielding an extensive provider-and-patient support program, developed based on feedback from a range of stakeholders.
Sanofi 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.
Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.
Despite an FDA rejection and changing winds in the field of multiple sclerosis, Sanofi believes its Genzyme unit is on an upward trajectory, talking up potential deals and could-be blockbusters for its pricey acquisition.
On Friday, the FDA accepted Sanofi's supplemental application for its once-rejected multiple sclerosis treatment Lemtrada for consideration, and a 6-month review period follows.
Sanofi has resubmitted Lemtrada, its long-in-development multiple sclerosis treatment, for FDA approval, gambling that a new analysis of the same data will sway regulators in a second review.
Sanofi felt the sting of lost sales potential when the FDA nixed its multiple sclerosis treatment Lemtrada in December. But the EU sees things a bit differently, and now a new nod from Britain's cost watchdog has unlocked some new top-line potential.
Late last year, Sanofi's MS drug Lemtrada was slapped down by the FDA. Sanofi investigators now tell FierceBiotech that two years after patients in Phase III studies received their last course of treatment, many are still clearly benefiting from the drug.