Mixed Ph III results for Sanofi MS drug candidate Lemtrada; EMA to broaden review of Multaq

French drug major Sanofi (Euronext: SAN) and its US biotech subsidiary Genzyme have announced mixed top-line results from CARE-MS I, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (to use the trade name Lemtrada if approved for multiple sclerosis) to the approved MS therapy, Merck KGaA’s Rebif (high dose subcutaneous interferon beta-1a), in patients with relapsing-remitting multiple sclerosis (RRMS). Genzyme is developing alemtuzumab in MS in collaboration with Germany’s Bayer HealthCare.

The potential of alemtuzumab, which is already sold as Campath for leukemia, in the multiple sclerosis setting was a critical factor in Sanofi increasing the value of its hostile bid for Genzyme last year to around $20 billion, including a contingent value right (CVR) for shareholders, which the US firm finally accepted earlier this year (The Pharma Letter February 16). Genzyme has said that it believes Lemtrada could generate annual revenues of $3.5 billion. The Genzyme CVR was down 10% to $2.29 in mid-day trading yesterday, while Sanofi’s shares fell 3.5% to $38.35.

55% relapse reduction vs Rebif