Over the past decade, drug development earned a reputation as one of the slowest, most frustrating and wildly expensive processes you'd find in any industry. And Lemtrada, Sanofi's "new" drug for multiple sclerosis, certainly helps demonstrate just how plagued the process can be, with a series of false starts and sudden stops as it was handed off from one company to the next. Today, Reuters' Ben Hirschler chronicled the 25-year R&D odyssey, which is expected to be capped soon with a European approval followed soon after by an FDA decision.
It all got started at Wellcome, now GlaxoSmithKline ($GSK), before that company gave up in the '90s, Hirschler reports. Leukosite got hold of it. Then Ilex, which was acquired by Genzyme in 2004. The Boston biotech geared up a major MS effort for it, only to wind up snapping and snarling with Sanofi ($SNY) over its real value as the pharma giant zeroed in on its go-slow buyout offer.
Whatever real or imaginary doubts he may have had during the buyout, Sanofi's Chris Viehbacher is a believer now. The drug, once used for B-cell chronic lymphocytic leukemia, was yanked off the market so that it could be developed and sold for MS, where Sanofi is expected to earn considerably more for the drug than it ever saw for leukemia.
It's taken so long to get to this point that innovative MS drugs like Tecfidera--developed by Biogen Idec ($BIIB)--have overtaken it, gaining an inside track on the blockbuster market for early-stage MS. Lemtrada will likely be used only as a secondary therapy for the sickest patients. "In Europe, there's little doubt it will be kept for fairly advanced stages of MS and I would expect it to be positioned similar to (Biogen's) Tysabri," Eric Le Berrigaud, an analyst at Bryan, Garnier, tells Reuters.
On the other hand, the premium Sanofi now expects to make from the drug should help ease the sting of criticism it's been subjected to since removing the cheaper cancer therapy from the market in order to make way for a pricey treatment for MS. Hit with generic competition, Sanofi needs this new-old drug to keep its revenue numbers in line with expectations.
Call it another case of better late than never.
- here's the story from Reuters