Canadians with Multiple Sclerosis One Step Closer to Accessing LEMTRADA®

Common Drug Review recommends funding the only MS treatment given once a year for two years

MISSISSAUGA, ON, June 22, 2015 /CNW/ - Genzyme Canada announced today that the Canadian Drug Expert Committee (CDEC), through the Common Drug Review (CDR), recommended to all participating provincial and other public drug plans that LEMTRADA® (alemtuzumab) be listed for the management of adult patients with relapsing-remitting multiple sclerosis (RRMS). Eligible patients with active disease defined by clinical and imaging features, and who have had an inadequate response to interferon beta or other disease-modifying therapies.

This announcement follows similar decisions by the Institut national d'excellence en santé et en services sociaux (INESSS) in Québec, and international health technology assessment agencies, such as the National Institute for Health and Care Excellence (NICE) in the UK, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia.

"We are pleased that Canadians with relapsing-remitting MS, who have had an inadequate response to other therapies, are one step closer to benefiting from an innovative new option to manage their disease," says Sylvia Leonard, National Vice President, Talent, Programs and Services, MS Society of Canada. "Access to new treatments is critical, and so we encourage provincial governments to remain responsive in their coverage based on this recommendation."

Approved in Canada in December 2013, LEMTRADA® is a recombinant humanized monoclonal antibody that requires only two annual treatment courses. It is a selective immunomodulator 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.

"The approval of LEMTRADA® represents a novel and important new treatment option for Canadians living with MS," says Dr. Anthony Traboulsee, Associate Professor of Neurology and Medical Director of the UBC Hospital MS Clinic of Vancouver Coastal Health. "Our own experience in treating 35 patients through clinical trials with LEMTRADA® has been extremely positive. LEMTRADA® demonstrated impressive effectiveness after only two treatment courses, and the benefits remained for several years after completing the treatment. We have not seen this type of prolonged remission before without ongoing treatment."

"While LEMTRADA® is already covered by many private insurers and the Quebec public formulary, this decision will help the remaining provincial drug plans provide this innovative medication that has the potential to transform the course of disease," says Peter Brenders, CEO of Genzyme Canada. "Genzyme continues to work with each province and territory to ensure that eligible Canadians who rely on provincial drug plans will have swift access to LEMTRADA®."

The CDEC recommendation is based on clinical data from the Phase III study CARE MS II (Coles 2012) and is in accordance with the Health Canada indication. The CARE MS II trial demonstrated 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.   

LEMTRADA®, with its novel mechanism of action, will complement the range of therapeutic options for those suffering from RRMS. It 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, Genzyme provides unique, comprehensive and free patient support through its MS One to One™ program.

Complete safety and prescribing information can be found at: http://www.genzyme.ca/thera/docs/ca_en_pdf_ms_lemtradapi.pdf

About MS in Canada
With 100,000 Canadians living with MS and three people newly diagnosed every day, Canada has one of the highest prevalence rates in the world. As most people are diagnosed with relapsing MS in their twenties and thirties, MS is the most common neurological disease affecting young adults in Canada.

As part of its commitment to those living with MS, Genzyme has developed the MS One to One™ program which offers comprehensive information services and ongoing education, as well as reimbursement navigation. Staffed by dedicated MS nurses and highly trained representatives, MS One to One provides support for individuals living with MS, their healthcare providers, family and loved ones.

About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.ca

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Genzyme® and LEMTRADA® are registered trademarks of Genzyme Corporation. All rights reserved.

SOURCE Genzyme Canada

For further information: Media Contacts: Robert Tam, Director, Government Affairs & Market Access, Genzyme Canada, (647) 271-5011, robert.tam@genzyme.com; Christine Beyaert, Cohn & Wolfe, (647) 259-3335, christine.beyaert@cohnwolfe.ca

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