Ontario adds LEMTRADA® (alemtuzumab) to the Exceptional Access Program for eligible patients

Unique treatment delivered in only two cycles one year apart

MISSISSAUGA, ON, July 21, 2016 /CNW/ - Sanofi Genzyme, the specialty care global business unit of Sanofi, is pleased to announce that the Government of Ontario has added LEMTRADA® (alemtuzumab) to the province's Exceptional Access Program (EAP) for eligible people living with relapsing-remitting multiple sclerosis (RRMS) effective today.  The EAP offers coverage, based on specific criteria, for Ontarians eligible for Ontario Drug Benefit Programs (ODBP). 

Ontario joins a growing list of provinces, including Quebec, Saskatchewan and Manitoba, in making the unique treatment available to patients 18 years or older who meet specific criteria.

"I am pleased to see the approval of alemtuzumab for Ontario patients. It is the only agent proven to be more effective than first line treatment for those whose disease was not adequately controlled with prior therapy," says Dr. Mark S. Freedman, Professor of Neurology, University of Ottawa.

"I welcome the addition of alemtuzumab to the Ontario provincial exceptional access formulary. This affords the opportunity for patients with public drug benefits and their treating physicians to, when clinically appropriate, utilize a very highly effective infrequent infusion therapy for treatment of active/aggressive multiple sclerosis," says Dr. Dan Selchen, Director, MS Clinic, St. Michael's Hospital, Toronto.

"We are excited knowing there is another treatment option for Ontarians living with relapsing-remitting MS, especially an option that would be available when other treatment options have not worked," says Lisa McCoy, President of the MS Society of Canada, Ontario Division. "Each person who lives with MS will experience their symptoms differently, and it's important that they have choices in order to manage their disease in a way that's right for them. The MS Society of Canada encourages those who might be considering this treatment to consult with their healthcare team."

Approved in Canada in December 2013, LEMTRADA® is indicated for the management of adult patients with RRMS, defined by clinical factors and imaging results, who have had an inadequate response to interferon beta or other disease-modifying therapies.¹

LEMTRADA® is delivered in two annual treatment courses, with the first given over five days in year one, and the second over three days in year two. As patients require monitoring at regular intervals between treatment courses and for 48 months following the final infusion, Sanofi Genzyme provides unique, comprehensive and free patient support through its MS One to One™ program.

LEMTRADA® is a monoclonal antibody. Monoclonal antibodies are proteins which bind to a unique site (called an antigen) on cells. LEMTRADA® binds to an antigen, called CD52, which is present at high levels on certain cells of the immune system. LEMTRADA® works on the immune system so that it may not attack the nervous system as much.²   Important and complete safety information about LEMTRADA can be found at:  https://www.genzyme.ca/Products.aspx.

The Phase III study CARE MS II showed that, as a second-line treatment, LEMTRADA® is more effective than interferon beta-1a in reducing the annual relapse rate and the time to onset of sustained accumulation of disability.³

"We are very pleased that Ontario has joined a growing list of provinces committed to improving the lives of RRMS patients by making LEMTRADA® available to those in need of another option," says Peter Brenders, General Manager, Canada, Sanofi Genzyme. "This exciting and unique treatment has the potential to transform lives."

About MS in Canada
The Multiple Sclerosis International Federation's 2013 Atlas of MS reported that Canada has the highest rate of MS in the world with 291 cases per 100,000 people, followed by Denmark (227), Sweden (189), Hungary (176), Cyprus (175) and the U.K. (164).⁴

MS is an autoimmune disease of the central nervous system which attacks myelin, the protective covering of the nerves, causing inflammation and often damaging the myelin. Myelin is necessary for the transmission of nerve impulses through nerve fibres. It is unpredictable and can cause symptoms such as extreme fatigue, lack of coordination, weakness, tingling, impaired sensation, vision problems, bladder problems, cognitive impairment and mood changes. Its effects can be physical, emotional and financial.⁵

MS can occur at any age, but is usually diagnosed between the ages of 15 to 40, peak years for education, career- and family-building. MS has been diagnosed in children as young as two years old – and in far older adults. MS is three times as likely to occur in women as in men and is more common in people of northern European background.⁵

About Sanofi – www.sanofi.ca
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. The Sanofi entities in Canada employ close to 1,700 people. In 2015 Sanofi companies invested $133.3 million in R&D in Canada, creating jobs, business and opportunity throughout the country.

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.ca.

LEMTRADA® and Genzyme® are registered trademarks of Genzyme Corporation. Sanofi® is a registered trademark of Sanofi.  All rights reserved.

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References
¹ LEMTRADA® Product Monograph. Available at https://www.genzyme.ca/Products.aspx
² LEMTRADA® Consumer Information.  Available at https://www.genzyme.ca/Products.aspx
³ Coles AJ et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. The Lancet. 2012 Nov 24;380(9856):1829-39. Available at: www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961768-1/fulltext. Accessed on June 26, 2016.
⁴ Multiple Sclerosis International Federation. Atlas of MS. http://www.msif.org/about-us/advocacy/atlas/?gclid=CNjEmKyRx80CFUwvgQodIxAN5A. Accessed June 26, 2016.
⁵ MS Society of Canada. Who Gets MS. https://mssociety.ca/about-ms/what-is-ms Accessed June 26, 2016.

SOURCE Sanofi Genzyme

Robert Tam, Sanofi Canada, 647-271-5011, [email protected]; Catherine R. Cunningham, Sanofi Canada, 514-956-6120, [email protected]; Alyssa Acorn, Cohn & Wolfe, 647-259-3304, [email protected]