Sanofi has unveiled positive late-stage data on Lemtrada, the multiple sclerosis drug that played a major part in the French firm's acquisition of Genzyme Corp earlier this year.
Sanofi has announced top-line results from the 581-patient CARE-MS I study, the first of two Phase III trials comparing Lemtrada (alemtuzumab) to Merck KGaA's blockbuster Rebif (interferon beta-1a) in patients with relapsing-remitting MS. The data showed that two annual cycles of alemtuzumab treatment resulted in a 55% reduction in relapse rate compared to Rebif over the two years of the study, "hence satisfying the first primary endpoint, and therefore meeting the predefined protocol criteria for declaring the study a success".
However, statistical significance was not achieved for the second primary endpoint, time to six-month sustained accumulation of disability, as compared to Rebif (8% vs 11%). Still, Sanofi chief executive Chris Viehbacher said the effect of Lemtrada on reducing relapses versus Rebif "is impressive, and the safety profile is consistent with the Phase II clinical trial experience".
Filing early next year
Another Phase III clinical trial, CARE-MS II, is currently underway, evaluating alemtuzumab against Rebif in MS patients who have relapsed while on therapy. Top-line results from that trial are expected to be available in the fourth quarter and the company expects to file for US and European approval of alemtuzumab in MS in early 2012; it has been granted fast-track designation by the US Food and Drug Administration.
The drug, which is already approved as Campath for B-cell chronic lymphocytic leukaemia, played a central role in Genzyme getting a higher price from Sanofi. In February, the latter upped its $18.50 billion offer to $20.1 billion and also agreed a tradable 'contingent value right', entitling Genzyme shareholders to payments linked to the success of Lemtrada. It was co-developed with Bayer, which retains an option to co-promote alemtuzumab in MS and will also pocket royalties up to a limit of $1.25 billion.
Dermik sold for $425 million
Meantime, Sanofi has sold its Dermik dermatology business to Canada's Valeant Pharmaceuticals International for $425 million in cash.
Dermik, which is particularly strong in the USA and Canada and had sales of $206 million in 2010, markets acne product BenzaClin, Carac for the treatment of keratoses and Sculptra, a facial injectable for the correction of facial wrinkles and folds. Also included in the deal is Sanofi’s Laval, which includes Dermik’s manufacturing facility.
Mr Viehbacher said the divestiture "allows us to rationalise our portfolio and improve focus on our core businesses".