Non-Insured Health Benefits Program Approves AUBAGIO(TM) for Relapsing Remitting Multiple Sclerosis

Once-daily oral tablet to be reimbursed for first-line use through exception process

MISSISSAUGA, ON, June 24, 2015 /CNW/ - Genzyme Canada announced today that Health Canada has approved AUBAGIO™ (teriflunomide) 14 mg as an expedited exception benefit product through the Non-Insured Health Benefits (NIHB) Program of Health Canada for eligible First Nations people and Inuit as a first-line oral tablet for relapsing remitting multiple sclerosis (RRMS).

AUBAGIO is a once daily oral tablet indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

"Aubagio with its combination of efficacy, safety, convenience and tolerability is an excellent first line choice for many patients with RRMS, said Dr. Daniel Selchen, Chief, Neurology, and Consultant, MS Clinic, St. Michael's Hospital in Toronto, Ontario.

"The NIHB approval of AUBAGIO represents a step forward in the management of MS," says Dr. Virginia Devonshire, Clinical Assistant Professor Neurology, University of British Columbia, and Director, MS Clinic, University Hospital of Northern BC. "AUBAGIO is a safe and effective oral treatment choice for relapsing MS."

"We are pleased that Health Canada has been responsive in listing another disease-modifying therapy option for those with multiple sclerosis who are eligible for the Non-Insured Health Benefits (NIHB) for First Nations people and Inuit," says Sylvia Leonard, National Vice President, Talent, Programs and Services, MS Society of Canada. "This responsiveness means that Canadians with MS have greater access to treatments to manage the effects of their disease. For individuals with MS who are interested in exploring treatment options, we encourage them to consult with their healthcare team to find the course that is most appropriate for them."

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.

"We applaud Health Canada for making AUBAGIO available to First Nations people and Inuit suffering from RRMS who meet appropriate criteria through the expedited exception process. With its once-a-day oral regimen, this will provide eligible patients an important alternative to injectable treatments," said Peter Brenders, General Manager, Genzyme 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 AUBAGIO (teriflunomide)
Approved in Canada in November 2013, AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). AUBAGIO™ is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years and are still benefitting from the treatment.

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

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 AUBAGIO™ are registered trademarks of Genzyme Corporation. All rights reserved.

SOURCE Genzyme Canada

Media Contacts: Robert Tam, Director, Government Affairs & Market Access, Genzyme Canada, [phone], [email protected]; Christine Beyaert, Cohn & Wolfe, [phone] ext. 4089, [email protected]