* 29 pct of Lemtrada patients showed disability level
improvement
* 65 pct of patients were relapse-free after two years
* Sanofi to file for regulatory approval in Q2
By Elena Berton
PARIS, April 24 (Reuters) – Sanofi’s experimental
Lemtrada multiple sclerosis drug could slow down or reverse
disability and keep patients free from relapses better than an
older therapy sold by German rival Merck, the French
drugmaker said on Tuesday.
New data from a late-stage study announced on Tuesday at the
American Academy of Neurology meeting in New Orleans showed
patients with disabling symptoms were more than twice as likely
to report a sustained reduction in disability with Lemtrada than
with Merck’s Rebif, Sanofi said.
This would be an important development as doctors
increasingly seek drugs that can prevent or slow down the
progression of the disease, not just relapses. Lemtrada is a key
drug candidate for Sanofi as the company searches for new
sources of growth to replace its ageing blockbuster products.
The study, which tested around 800 patients that had not
responded well to a previous treatment for their condition,
found that 29 percent of patients treated with Lemtrada reported
an improvement in their disability level, compared with 13
percent among those who took Rebif.
The data also showed that 65 percent of patients treated
with Lemtrada were relapse-free after two years, compared with
47 percent with Rebif.
The results “raise the bar” in the treatment of multiple
sclerosis, Michael Panzara, therapeutic area head in multiple
sclerosis, immune diseases and neurology at Sanofi’s Genzyme
unit told Reuters.
“It means that this group of patients with high unmet needs
… will have an option that not only will help slow the
progression of disability, which was the target in previous
studies, but also hopefully – at least in some of them – will
bring an improvement and recovery of function,” Panzara said.
“People get better on this treatment. This is a big
difference.”
MS, which has no cure, affects 2.5 million people worldwide.
It is a chronic, often disabling disease that attacks the
central nervous system and can lead to numbness, paralysis and
loss of vision.
Most MS patients have a form called relapsing-remitting,
with sudden flare-ups followed by periods of recovery, while
others have a progressive form that so far is less treatable.
Lemtrada, which Sanofi is developing in collaboration with
Bayer, is given intravenously every day for five
consecutive days when treatment is started and then another
three times one year later.
Other novel MS drugs like Novartis’s recently
launched Gilenya and Biogen Idec’s experimental
medicine BG-12 are given as once- or twice-daily pills.
Although there were no life-threatening or fatal infections
in the trial, side effects remained an issue for the novel
treatment, as in previous tests.
Around 16 percent of patients on Lemtrada had autoimmune
thyroid-related side effects, compared with 5 percent on Rebif,
and 1 percent developed bleeding disorder immune
thrombocytopenia.
Other side effects included a higher incidence of infections
among patients taking Lemtrada.
The commercial potential of the drug, already sold under the
brand name Campath as a leukaemia treatment, was an important
sticking point in the protracted merger talks between Sanofi and
Genzyme.
As part of the deal struck by Genzyme’s management, Sanofi
set up a so-called contingent value right (CVR) tied to
Lemtrada’s development targets and commercial milestones.
Investors received one CVR for each Genzyme share they owned
and stand to receive payments of as much as $14 per CVR if
Lemtrada wins U.S. approval and reaches sales goals, and if the
company meets production goals for existing Genzyme drugs.
Analyst views on Lemtrada vary widely, ranging from 300
million euros to 1 billion euros in peak sales.
Sanofi expects to file for U.S. and European Union approval
of Lemtrada, which has fast-track designation, in the second
quarter of 2012.
The company has developed another MS drug, once-daily pill
Aubagio, which is currently under review by the FDA and EMA.
(Reporting by Elena Berton; Editing by Helen Massy-Beresford)
