Genzyme MS drug shines in head-to-head trial with Rebif

Genzyme’s multiple sclerosis candidate Lemtrada has impressed in a new phase II head-to-head trial.

Five years’ worth of mid-stage data for Lemtrada (alemtuzumab) showed that 65% of patients were free of clinically-active disease, compared to 27% on Merck’s interferon treatment Rebif.

The data, which was presented at the 63rd Annual Meeting of the American Academy of Neurology, also showed that 72% of patients treated with Lemtrada were relapse-free compared to 41% for Rebif.

Two phase III studies investigating Lemtrada, CARE-MS I and II, are currently ongoing with top-line results expected to be available in the second half of this year.

Lemtrada’s US application has been fast-tracked by the FDA and Genzyme expects to file for US and European approvals in early 2012.

Analysts predict Lemtrada, which is already licensed to treat chronic lymphocytic leukaemia, could make peak annual sales of between $750 million to $2 billion for Genzyme and its new owners Sanofi-Aventis.

Many patients with MS also suffer from visual impairment, and a second abstract presented at the American Academy of Neurology meeting showed Lemtrada was twice as likely to improve vision problems when compared to Rebif.

The drug will face tough competition from Novartis’ oral MS drug Gilenya (fingolimod), which received EMA approval in March and FDA approval last year.

In one key study Gilenya was shown to cut relapses of MS by 52% at one year compared to Rebif and analysts predict blockbuster sales of around $2.5 billion for Novartis’ drug.

Ben Adams