• The decision follows positive recommendation from the Institut national d'excellence en santé et services sociaux (INESSS) recognising the urgency and need for a treatment for patients with SMA and the robust clinical data of nusinersen
• SPINRAZA will be listed on the hospital formulary for a broad population of SMA patients irrespective of age

MISSISSAUGA, Ontario, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Biogen Canada applauds the Government of Quebec’s decision to cover  SPINRAZA for a broad population of patients with Spinal Muscular Atrophy (SMA) in the province. The announcement was made by the Minister of Health, Madame Danielle McCann on December 18, 2018, following a positive recommendation from the Institut national d'excellence en santé et services sociaux (INESSS) to expand coverage to include pre-symptomatic and symptomatic patients with 5q SMA Type 1, 2 and 3 of all ages.

SMA is a genetic disease characterized by the loss of motor neurons which causes progressive muscle weakness and wasting, leading to severe handicap and death in some severely affected patients. While SMA is a rare disease and affects roughly only one in ten thousand people, its symptoms can be devastating, with some patients not living past their second birthday, and others dependent on respiratory and feeding equipment and confined to a wheelchair for life.

Nusinersen is the first and only approved treatment for SMA. Through an extensive clinical development program, nusinersen has shown significant improvements in survival rates and motor function across a broad range of types and ages of SMA patients.

Previous recommendations from the Health Technology Assessment (HTA) bodies, Canadian Association of Drugs and Technologies in Health (CADTH) and INESSS, had been limited to Type 1 SMA patients. In July 2018, Biogen resubmitted updated clinical trial data to both CADTH and INESSS, requesting reconsideration for broader coverage of SPINRAZA to treat patients with other SMA types. The updated recommendation from INESSS is a result of that resubmission.  The result of the review by CADTH is expected in January 2019. Biogen remains hopeful that other provinces will soon join Quebec in providing access to SPINRAZA for a broad population of SMA patients of all types and all ages, positioning Canada to join over 43 other countries where SPINRAZA is available for a broad population of SMA patients.

"Today is a day of celebration for patients with SMA in Quebec, the first province in Canada to announce broad access to the life-changing treatment of SPINRAZA. We now look to the rest of Canada to follow suit and ensure that all Canadians living with this rare, debilitating disease are granted the same access to treatment," said Marina Vasiliou, Vice President and General Manager of Biogen Canada.

Statement from Cure SMA Canada: 

“We at Cure SMA Canada are incredibly happy to hear that our Quebec patients are now finally able to access treatment.  We are quite sure the rest of Canada will follow suit and wait with baited breath to hear CADTH’s recommendation.”

- Susi Vander Wyk, Executive Director, Cure SMA Canada 

Statement from Cure SMA Quebec:

«Nous sommes ravis que la valeur thérapeutique du Spinraza soit enfin  reconnue et que la Ministre de la santé ait décidé de donner l’accès à tous ceux atteints d’amyotrophie spinale.»

Amy Loignon et Isabelle Boudreault. Co-présidentes de Cure SMA Quebec

Statement from the Muscular Dystrophy Canada (MDC): 

“Muscular Dystrophy Canada (MDC) was pleased to support both the initial and subsequent reviews by providing a comprehensive patient submission. Ensuring our community has a strong and credible voice in all matters related to trials and treatments is at the forefront of our work in Canada,” commented, Muscular Dystrophy Canada CEO, Barbara Stead-Coyle. “This is a life changing treatment for our SMA community.  We applaud the Minister of Health and Social Services Danielle McCann, and the Quebec government for reconsidering their initial decision and expanding access for more patients.”

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer's disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

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For further information, please contact:

Therese Gagnon-Kugler, corporate relations,

therese.gagnonkugler@biogen.com