Saskatchewan includes LEMTRADA® (alemtuzumab) on MS Drugs Program for eligible patients

Unique treatment delivered in only two cycles one year apart

MISSISSAUGA, ON, July 5, 2016 /CNW/ - Sanofi Genzyme is pleased to announce that the Government of Saskatchewan has added LEMTRADA® (alemtuzumab) to the province's MS Drugs Program for eligible people living with relapsing-remitting multiple sclerosis (RRMS).

Saskatchewan is one of the first provinces among pan-Canadian Pharmaceutical Alliance (pCPA) members to provide coverage.  The province of Québec included LEMTRADA® on its provincial formulary in 2014 under "Médicament d'exception" as second-line treatment for people living with RRMS.

"We are pleased to continue to see Saskatchewan leading the way in the approval of new therapies for MS to the Saskatchewan MS Drugs Program. Every person who lives with MS experiences their disease differently, and therefore it is important to have access to all Health Canada approved therapies in order to find the treatment that is right for them.  We are excited to have new therapies available to those who live with MS as well as new modes in which therapies are administered, offering greater options in disease management," says Jessica MacPherson, Director, Government Relations and Research Support, Saskatchewan Division, MS Society of Canada.

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 an exciting new treatment for Canadians living with relapsing-remitting multiple sclerosis.  It has the potential to substantially change the course of their disease and prevent disability progression," says Dr. Wendi Fitzpatrick, Clinical Assistant Professor, Neurology, University of Saskatchewan.

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.

LEMTRADA® (alemtuzumab) concentrate for solution for IV infusion, 12mg/1.2mL (Lemtrada-GZY) will be covered in Saskatchewan for eligible beneficiaries of the Ministry of Health's Drug Plan for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS), if ALL of the following clinical criteria are met:

• Active disease defined by clinical and imaging features (i.e., one new lesion);
• At least one relapse while on at least six months of a disease modifying therapy within the last 10 years;
• At least two attacks (first episode or relapse) in the previous two years, with at least one attack in the previous year;
• An inadequate response to a treatment course at least six months in length (i.e., at least one attack) to at least ONE disease modifying therapy listed on the Saskatchewan Formulary;
• An Expanded Disability Status Scale (EDSS) score of five or less;
• The medication is being prescribed by a neurologist with experience in the treatment of multiple sclerosis.

Approval period: Two years (i.e., 8 vials).

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 to learn that the transformative potential of LEMTRADA® will be available to those in Saskatchewan living with relapsing-remitting MS should they need it," says Peter Brenders, General Manager, Canada, Sanofi Genzyme. "We applaud the province's government for its leadership in health care, as this approval underscores LEMTRADA®'s capability to have a positive impact on the lives of patients."

About MS in Saskatchewan
The Multiple Sclerosis International Federation's 2013 Atlas of MS reported that Canada had 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 The Government of Saskatchewan's Multiple Sclerosis Advisory Panel, in its report published in February, 2016, reported that the the prevalence is even higher in Saskatoon where it's estimated that 340 people per 100,000 live with MS. The panel reported that provincial prevalence rates are not known but are estimated to be high given the high prevalence in Saskatoon.⁵

According to the MS Society of Canada, "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."⁶

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. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). 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 treatments in oncology, for multiple sclerosis and 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® is a registered trademark of Genzyme Corporation.

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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 Government of Saskatchewan. Multiple Sclerosis Advisory Panel Recommendations. February 16. Page 3. Accessed June 26, 2016.
⁶ MS Society of Canada. Who Gets MS. https://mssociety.ca/about-ms/what-is-ms Accessed June 26, 2016.

SOURCE Sanofi Genzyme

Media Contacts: 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]