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.
Europe's Committee for Medicinal Products for Human Use (CHMP) recommended Lemtrada for the treatment of adults with relapsing remitting multiple sclerosis (RRMS). Sanofi ($SNY) is also hoping for FDA approval for Lemtrada later this year. It said in a statement that the FDA has extended its review period by 90 days but that it did not ask the company for additional clinical data.
Before the EU approval, Reuters says analysts were forecasting Lemtrada could hit $650 million in sales by 2017. It has taken a very long time to get Lemtrada to the market for treating MS and, in the meantime, there are competitors that are already there with innovative products. Biogen Idec ($BIIB) beat it there with Tecfidera, for example, and it has been sweeping the market.
CHMP's decision on Aubagio was a reversal from its earlier recommendation against granting it "new active substance" (NAS) designation, Reuters points out. That would have meant it could have faced generic competition in as little as three years. The drug was approved last year in the U.S. as a once-daily, oral treatment for patients with relapsing forms of multiple sclerosis. To break into the market, Sanofi decided to price it at $45,000 a year, 7% less than Teva Pharmaceutical's ($TEVA) Copaxone and 28% less than Gilenya from Novartis ($NVS).
The French drugmaker can use all the added revenues it can scrape in. Its first quarter its sales were down 5.3%, while its profits fell 34%. It has been hit by generic competition to big sellers like its bloodthinner Plavix and blood pressure treatment Avapro.
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