Serono's oral cladribine fast-tracked by FDA

Geneva, Switzerland-based Serono's oral cladribine has been designated a fast-track product by the US Food and Drug Administration. This designation covers patients with relapsing forms of multiple sclerosis. The announcement was made just ahead of the company receiving a takeover offer from Germany's Merck KGaA, under which its owning Bertarelli family had accepted a $13.5 billion bid for its 64.5% stake, on September 21.

The firm's proprietary oral formulation of cladribine for the treatment of multiple sclerosis is currently being evaluated in a multicenter, multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS OrallY). It is a two-year, double-blind, placebo-controlled study involving over 1,200 patients. Patient enrollment into this pivotal trial is planned to be completed by the end of 2006.

Ernesto Bertarelli, chief executive of Serono, said: "as a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment."