Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

"Lemtrada is an important new treatment option for Canadians with MS. It has impressive effectiveness following two treatment courses for those patients with active relapsing MS," said Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. "Our own local experience in treating 35 patients through clinical trials with Lemtrada has been extremely positive."

Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. Approval in Canada follows the recent approval of Lemtrada in the European Union. Marketing applications for Lemtrada are also under review in numerous other countries, including the US and Mexico.

More than 2.3 million people worldwide have been diagnosed with MS, including approximately 100,000 people in Canada.

Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

"The approvals of Lemtrada in Canada and the EU are further recognition of its potential as a transformative treatment option for patients living with active MS," said Genzyme President and CEO, David Meeker. "Lemtrada is now approved in 30 countries, and we are very pleased that Canadian patients and physicians will have access to this important new treatment option."

The Canadian approval was based on data from the Lemtrada clinical development program comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who had active disease.

The most common side effects of Lemtrada are infusion associated reactions (headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills and flushing) and infections (nasopharyngitis, urinary tract and upper respiratory tract). Autoimmune conditions, including thyroid disease, cytopenias, glomerulonephritis, and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.