PARIS, March 21 The effects of Sanofi's
experimental multiple sclerosis drug Lemtrada continue
to benefit the majority of patients long after they have
completed their treatment, the French drugmaker said on
In an extension trial sponsored by the company that followed
up patients who had taken part in two late-stage studies, more
than half did not experience any relapses in the first year
after completing a two-course treatment with Lemtrada.
Multiple sclerosis is a chronic, often disabling disease
that attacks the central nervous system and can lead to
numbness, paralysis and loss of vision. It affects 2.5 million
people worldwide and has no cure.
Lemtrada, which is given via an intravenous drip for five
days and then for three days a year later, has the potential to
re-programme the immune system and could potentially change the
long-term progression of the disease.
"When you think about therapies to treat MS you think of
therapies that are taken chronically, that when you stop them
their effects are gone," Michael Panzara, therapeutic area head
for MS and neurological research at Sanofi's rare disease unit
Genzyme, told Reuters.
"What you have here is a change in the immune system and a
The study showed that more than 80 percent of patients did
not require a third course of Lemtrada in the first year after
treatment, while more than 70 percent of patients showed
improved or stable disability after three years.
"These findings are important because they suggest that the
benefits of Lemtrada as observed in phase III studies are
maintained, even though most patients did not receive further
dosing," said Edward Fox, director of the Multiple Sclerosis
Clinic of Central Texas, who presented the results at a medical
congress in San Diego, California.
Lemtrada is under review by the European Medicines Agency
and the U.S. Food and Drug Administration, which are expected to
give their feedback by the end of 2013.
In addition to Lemtrada, Sanofi has developed MS pill
Aubagio to boost growth after the patent loss on its ageing
blockbusters and further its ambition to become a major player
in this market.
Aubagio was launched in the U.S. in October, generating
sales of 7 million euros ($9 million) in the last quarter of
The European Medicines Agency is due to give its verdict on
the drug by the end of the month.
Shares in Sanofi, which have risen around 8 percent in the
last month in the run-up to EMA's decision, closed at 77.32
euros on Thursday.
($1 = 0.7722 euros)
(Reporting by Elena Berton; editing by Keiron Henderson)