* Lemtrada significantly reduces relapses vs Merck's Rebif
* Sanofi aims to file for regulatory approval in Q1 2012
PARIS Oct 22 French drugmaker Sanofi
said on Saturday that its experimental multiple sclerosis drug
Lemtrada worked better than an older drug sold by competitor
Merck KGaA at keeping patients free from relapses.
New data from a late-stage trial showed that 78 percent of
patients treated with Lemtrada remained relapse-free for two
years, compared with 59 percent using Rebif, an older multiple
sclerosis drug sold by Germany's Merck.
Lemtrada is a key experimental product at Sanofi's Genzyme
unit. The fortunes of the drug are closely watched by holders of
Genzyme Contingent Value Rights certificates issued to
shareholders as part of the U.S. company's takeover deal.
CVRs represent an extra fee holders will receive if Lemtrada
hits certain targets or when Genzyme meets other milestones.
The commercial potential of the drug, already sold under the
brand name Campath as a leukaemia treatment, was a key bone of
contention between Sanofi and Genzyme during takeover talks.
Multiple sclerosis, which affects 2.5 million people
worldwide, is a chronic and progressive disease that attacks the
central nervous system.
Previously published data from the same late-stage study were
mixed. Although Lemtrada was found more effective than Rebif at
preventing relapses, it did not prevent the disease from
becoming disabling, as it had in earlier trials.
The results of the latest late-stage trial showed that
side-effects, including respiratory and urinary tract
infections, were mild to moderate, Sanofi said.
Serious adverse events were similar between Lemtrada and
Rebif, Sanofi said, with 18.4 percent of patients on Lemtrada
suffering from side effects that included autoimmune disorders
compared to 14.4 percent in patients taking Rebif.
The drug's prospects should become clearer once the results
of another late-stage trial are published by year-end. The study
is comparing Lemtrada with Rebif in multiple sclerosis patients
who have relapsed while on therapy.
Sanofi plans to submit Lemtrada for U.S. and European Union
marketing approval in the first quarter of 2012. The drug, if
approved, will face competition from Novartis's
(Reporting By Elena Berton; Editing by Helen Massy-Beresford)