Genzyme, the U.S. biotechnology unit of France's Sanofi SA
(SNY), Tuesday said latest results from a late-stage clinical study
showed its multiple sclerosis drug Lemtrada significantly reduced
relapses and any worsening of the condition, and in some cases
showed a reversal in disability.
In a Phase III trial called CARE-MS II involving 840 patients,
the relapse rate was reduced by 49%, compared with an older drug
called Rebif, or subcutaneous interferon beta-1a, which is sold by
German rival Merck KGaA (MRK.XE).
The company said 65% of patients treated with Lemtrada were
relapse-free after two years into the study, compared with 47%
treated with Rebif.
Genzyme is developing the drug, also known as alemtuzumab, in
collaboration with German drug maker Bayer AG (BAYN.XE), and Sanofi
aims to launch the drug by the end of next year. Multiple sclerosis
is a chronic disease that attacks the central nervous system.
"We believe these ground-breaking results from CARE-MS II,
including reversal of disability accumulation in some patients,
achieved over the standard therapy Rebif, provide a message of hope
for people living with MS," said David Meeker, Genzyme's CEO, said
in a statement, adding: "We are on track to submit alemtuzumab for
review to U.S. and EU regulatory authorities in the second quarter
of this year."
In the CARE-MS II trial, alemtuzumab was given as an injection
eight times over the course of the two-year study. The first
treatment course of alemtuzumab was administered on five
consecutive days, and the second course was administered on three
consecutive days 12 months later. Rebif was administered by
injection three times per week, each week, throughout the two years
of study.
Sanofi, which is struggling with patent expiries on its
blockbuster drugs, bought Genzyme in February 2011 in a bid to
widen its research net.
--By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com