TECFIDERA™, a First-Line Oral Treatment for Multiple Sclerosis, Now Funded in Saskatchewan

MISSISSAUGA, ON, May 1, 2014 /CNW/ - Biogen Idec Canada announces today that Saskatchewan is the first province in Canada to fund TECFIDERA™ (dimethyl fumarate) as an Exception Drug Status (EDS) benefit through the Saskatchewan MS Drugs Program. TECFIDERA™ is a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA™ is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the progression of disability.1

"It's exciting news that Saskatchewanians with relapsing-remitting multiple sclerosis will now have access to an oral choice for first-line therapy to help reduce their disease activity," said Dr. Andrew Kirk, Professor and Head of Neurology at the University of Saskatchewan, Saskatoon, Saskatchewan. "This expansion of our available therapeutic options will directly benefit the many people in the province with MS."

Effective May 1, 2014, TECFIDERA™ will be covered in Saskatchewan for eligible patients, over the age of 18, who have clinical definite RRMS with at least two documented attacks of MS during the previous two years, and are fully ambulatory for 100 metres without aids (canes, walkers or wheelchairs) with an Expanded Disability Status Scale (EDSS) of 5.5 or less. Applications for patients under 18 will be considered.

"People with relapsing-remitting MS who live in Saskatchewan now have access to another treatment option to help manage their MS," said Jessica MacPherson, Director of Government Relations and Research Support at the MS Society of Canada, Saskatchewan Division. "We are very pleased that Saskatchewan Health continues to be responsive in the public listing of new therapies that impact people living with MS."

The Health Canada approval of TECFIDERA™ was based on findings from two global Phase III two-year studies, DEFINE and CONFIRM. In DEFINE, TECFIDERA™, administered twice-daily, significantly reduced the proportion of patients who relapsed by 49 per cent (p<0.0001), the annualized relapse rate (ARR) by 53 per cent (p<0.0001), and 12-week confirmed disability progression, as measured by the EDSS by 38 per cent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA™ significantly reduced ARR by 44 per cent (p<0.0001) and the proportion of patients who relapsed by 34 per cent (p=0.002) compared to placebo at two years. Both studies also showed TECFIDERA™ significantly reduced MS lesions compared to placebo, as measured by magnetic resonance imaging (MRI). In DEFINE, TECFIDERA™ significantly reduced the odds of having Gd+ lesions by 90 per cent and T2-hyperintense lesions by 85 per cent.1

"More than 65,000 patients worldwide are now being treated with TECFIDERA™ and Saskatchewan's provincial funding is another important step towards ensuring more people living with MS have access to this important first-line therapy," said Paul Petrelli, President and General Manager, Biogen Idec Canada. "Biogen Idec Canada will continue to work closely with other provincial reimbursement agencies to secure funding that will make TECFIDERA™ accessible to all Canadians."

About Biogen Idec ONE™ Patient Services Program
Biogen Idec Canada is committed to delivering best-in-class services to care for MS patients. All TECFIDERA™ patients have access to a Regional Support Nurse in their region that provides personalized support for patients and healthcare providers in all aspects of patient care, from treatment to reimbursement. This provides healthcare professionals and patients the opportunity to work directly with one nurse per region across all Biogen Idec Canada MS products, which is intended to enhance the quality and continuity of care that Biogen Idec ONE™ can provide to patients. Biogen ONE™ will also assist physicians and patients with the paperwork associated with the Exception Drug Status benefit application for TECFIDERA™ in Saskatchewan. For more information about the Biogen Idec ONE™ program, call 1-855-MSONE-00 or 1-855-676-6300.

About MS in Canada
MS is an unpredictable, often debilitating disease of the central nervous system (CNS) that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage.2 When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted.2 The result of damaged myelin may be a wide variety of symptoms including fatigue, weakness, muscle spasms, pain, tremors, double vision, bladder and bowel dysfunction, cognitive deficits and loss of mobility, among other problems.2,3

Canada is known for having one of the highest prevalence of MS in the world. Currently, more than two million people are estimated to suffer from MS worldwide, including an estimated 100,000 Canadians.

About TECFIDERA
TECFIDERA™ provides a new approach to treating MS and is the only known compound to activate the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend against inflammation and oxidative stress caused by conditions like MS. In vivo and in vitro research suggests that TECFIDERA™ can reduce the impact of inflammatory cells on the CNS and may provide protection against harmful agents in CNS cells. These effects may enhance the CNS cells' ability to reduce inflammatory stress that plays a role in the physiological processes associated with MS.5

About Biogen Idec Canada
Biogen Idec Canada is the Canadian affiliate of Biogen Idec. Through cutting-edge science and medicine, Biogen Idec discovers, develops, manufactures and markets therapies for diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, with a presence in Canada since 1998, it is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For press releases and additional information about the company, please visit www.biogenidec.ca.

References:
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[1]

TECFIDERA™ Product Monograph. http://www.biogenidec.ca/product_portfolio.aspx?ID=14979.

[2]

"Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/symptoms.htm.

[3]

Nicholas G. LaRocca, "Impact of Walking Impairment in Multiple Sclerosis." National Multiple Sclerosis Society 4, no.3 (2011): 190.

[4]

"About MS." Multiple Sclerosis Society of Canada, accessed April 29, 2014, http://mssociety.ca/en/information/

[5]

BG-12 (dimethyl fumarate) Fact Sheet.

SOURCE GCI Group

For further information: Rick Maddalena, GCI Group (Canada), 416-486-7225, rick.maddalena@gcicanada.com