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 (>> Merck KGaA).
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 (>> Bayer AG), 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; [email protected]