Sanofi moves on Lemtrada; Novartis Indian patent case

French drug major Sanofi's (Euronext: SAN) USA-based rare diseases subsidiary Genzyme is pulling leukemia drug Campath (alemtuzumab) from the market to prepare for its launch under a different dosage and as a multiple sclerosis treatment that will be branded as Lemtrada, according to a report from Reuters.

The withdrawal, meant to prevent the off-label use of Campath as a MS drug, is already under way in some European countries and will be effective in the USA on September 4, a Genzyme spokesman said. Lemtrada, which Sanofi submitted for approval with health regulators in Europe and the USA, has a PDUFA date of second-quarter 2013 for a US Food and Drug Administration decision for approval.

“We think that this stoppage shows Sanofi's confidence in the approval of Lemtrada in multiple sclerosis," said Bryan Garnier analyst Eric Le Berrigaud, quoted by the Chicago Tribune, who estimates the drug could generate sales of $400 million in 2018, if approved. As part of its argument for an increased takeover bid from Sanofi back in 2010, Genzyme forecast that the MS indication for alemtuzumab could generate total sales of the product in the region of $3.5 billion a year, which Sanofi contested, saying it believes the MS potential is more like $700 million.

The withdrawal will also enable Sanofi to adjust Lemtrada's price closer to that of rival multiple sclerosis drugs, Mr Le Berrigaud said. Rivals include Tysabri (natalizumab), an injectable drug sold by Biogen Idec and Elan, while Novartis markets MS drug Gilenya (fingolimod). Campath, which last year had sales of $76 million, will continue to be available through patient access programs in the 50 countries where it has been available since its launch in 2001.