Sanofi: MS drug Lemtrada has positive trial result

By Sten Stovall

LONDON -(MarketWatch)- French drug maker Sanofi SA (SAN.FR) said Monday the results of a late-stage trial of multiple sclerosis drug Lemtrada were positive.

The two-year study compared the experimental therapy, also known as alemtuzumab, against Merck KGaA’s MS medicine Rebif in 581 patients with relapsing-remitting multiple sclerosis who had not had prior treatment for their illness.

“The substantial effect of alemtuzumab on reduction of relapse rate over and above that seen with Rebif confirms our experience gathered over many years and demonstrated in the Phase 2 study,” said Alastair Compston who headed the study, called CARE-MS 1, and who leads the department of clinical neurosciences at the University of Cambridge.

Another Phase 3 clinical trial, CARE-MS II, is currently underway, evaluating Lemtrada against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. Top-line results from that trial are expected in the fourth quarter of this year.

Sanofi’s chief executive officer Christopher Viehbacher said in a statement Monday that “we look forward to the results from CARE-MS II, which will provide clinical data in patients whose disease was not adequately controlled on other multiple sclerosis therapies. Today’s results are an important step forward in the development of alemtuzumab.”

Sanofi acquired Lemtrada, or alemtuzumab, through a complex licensing agreement whereby German rival Bayer AG (BAYN.XE, BAYRY) sold the rights to Genzyme which has now been incorporated within the French drug maker. That agreement limits Bayer’s share to royalties from global sales up to a limit of $1.25 billion.

Sanofi expects to file the drug for U.S. and European Union approval in multiple sclerosis in early 2012 and has been granted fast track designation by the U.S. Food and Drug Administration.

Multiple sclerosis is an inflammatory disease of the brain and spinal cord, in which an overactive immune system attacks the nerve fibers responsible for sending signals to the rest of the body. Its symptoms include impaired vision, muscle weakness and spasm, fatigue, memory loss and depression. Relapsing remitting MS is the most common form of the disease.

Alemtuzumab, an injected medicine, is a humanized monoclonal antibody which is currently licensed to treat a type of leukaemia.