Health Canada Approves New Strength For TECFIDERA(TM), A First-Line Oral Treatment For Multiple Sclerosis

TECFIDERA™ now available as 240 mg delayed-release capsules

MISSISSAUGA, ON, Feb. 18, 2014 /CNW/ - Today, Biogen Idec Canada announces the Health Canada approval of TECFIDERA™ (dimethyl fumarate) 240 mg strength capsule, a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA™ was first approved by Health Canada in April 2013 as a 120 mg capsule indicated as monotherapy for the treatment of relapsing-remitting MS to reduce the frequency of clinical exacerbations and to delay the progression of disability.¹

"Oral dimethyl fumarate is an important treatment option for people with multiple sclerosis, combining easy administration with a clinically proven safety and efficacy profile," said Dr. Marcelo Kremenchutzky, Director of the Multiple Sclerosis Clinic, London, Ontario. "The 240 milligram approval provides a flexible dosing option for patients and physicians, which may help improve adherence."

The current dosing of TECFIDERA™ is two 120 mg capsules, twice a day orally. The new 240 mg strength option allows patients to take one TECFIDERA™ 240 mg capsule twice a day.² The 120 mg option will remain available for initial dosing and dose reduction.

The Health Canada approval of TECFIDERA™ in April 2013 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 Expanded Disability Status Scale (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 lesions in the brain 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.³

About TECFIDERA™
TECFIDERA™ provides a new approach to treating MS and is the only known compound to activate the Nrf2 pathway, although the 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. Research in vivo and in vitro in animals suggests that TECFIDERA™ can reduce the impact of inflammatory cells on the central nervous system (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.⁴

Important Safety Information
The most common side effects associated with TECFIDERA™ seen in clinical trials are flushing and gastrointestinal events such as diarrhea, nausea, and abdominal pain. Other side effects include a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued, and elevations of hepatic transaminases primarily during the first six months of treatment. Reports of protein in the urine were slightly higher for patients treated with TECFIDERA™ although the significance of these clinical observations is unknown. There was no increased risk of malignancy, infections or serious infections associated with TECFIDERA™ treatment.

About Biogen Idec ONE™ Patient Services Program
Biogen Idec Canada is committed to delivering best-in-class quality and 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 enables healthcare providers 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. For more information about the Biogen Idec ONE™ program, call 1-855-MSONE-00 or 1-855-676-6300.

About Multiple Sclerosis
MS is an unpredictable, often debilitating disease of the CNS that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage.⁵ When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted.⁶ 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.^7,8

Multiple Sclerosis in Canada
Canada is known for having one of the highest prevalence of MS in the world.⁹ Currently, more than two million people are estimated to suffer with MS worldwide,¹⁰ including an estimated 100,000 Canadians.¹¹

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 and the company generates more than $5 billion in annual revenues. For press releases and additional information about the company, please visit www.biogenidec.com.

References:
¹ TECFIDERA PM. Page 3.
² TECFIDERA PM. Page 15.
³ Thematic Messaging Document for DEFINE/CONFIRM Publications.
⁴ BG-12 (dimethyl fumarate) Fact Sheet.
⁵ "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2014, http://mssociety.ca/en/information/symptoms.htm.
⁶ "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2014, http://mssociety.ca/en/information/symptoms.htm.
⁷"Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2014, http://mssociety.ca/en/information/symptoms.htm.
⁸ Nicholas G. LaRocca, "Impact of Walking Impairment in Multiple Sclerosis." National Multiple Sclerosis Society 4, no.3 (2011): 190.
⁹ "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada, accessed January 6, 2014, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.
¹⁰ Hans-Peter Hartung, "Impact of mobility impairment in multiple sclerosis 1 - Healthcare professionals perspectives." European Neurological Review: 110.
¹¹ "About MS - What is MS." Multiple Sclerosis Society of Canada, accessed January 7, 2014, http://mssociety.ca/en/information/ms_what.htm#q3.

SOURCE: Biogen Idec Canada

Rick Maddalena
GCI Group (Canada)
416-486-7225
[email protected]