Health Canada Approves TECFIDERA™ As A First-Line Oral Treatment For Multiple Sclerosis

TECFIDERA™, formerly BG-12, provides a combination of proven efficacy and favourable safety profile

MISSISSAUGA, ON, April 9, 2013 /CNW/ - Today, Biogen Idec Canada announced the Health Canada approval of TECFIDERA™ (dimethyl fumarate) delayed-release capsules, formerly BG-12, as 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

"The approval of dimethyl fumarate is a significant advancement for people living with multiple sclerosis, helping address many treatment barriers that may affect medical intervention," said Dr. Marcelo Kremenchutzky, lead clinical researcher and Director of the Multiple Sclerosis Clinic, London, Ontario. "With this new oral medication, Canadian patients have access to a disease-modifying treatment that offers convenient oral administration coupled with clinically proven effectiveness and favorable safety profile."

Findings from both Phase III two-year studies, DEFINE and CONFIRM, showed that TECFIDERA demonstrated robust clinical and radiological efficacy over time in a broad range of patients with RRMS, while maintaining consistently favourable safety and tolerability.2

"We welcome the approval of an additional treatment option for people living with relapsing forms of MS," said Sylvia Leonard, President, Ontario and Nunavut Division and National Vice-President, Programs and Services of the Multiple Sclerosis Society of Canada. "As with any new therapy, we recommend that people with MS contact their physician to find out more information."

MS attacks the protective covering, or myelin, around the nerves of the central nervous system (CNS).3 Nerve damage, caused by inflammation, occurs when the body's immune cells attacks the nervous system along any area of the brain, optic nerve, and spinal cord.4

TECFIDERA is the only compound for the treatment of multiple sclerosis (MS) known to activate the Nrf2 pathway, in vitro and in vivo animals and humans, a central mechanism of cellular defense.5 TECFIDERA may work by changing the way the body's immune system works, to help keep it from further damaging the brain and spinal cord, although the exact mechanism is not known.6

"We believe TECFIDERA will raise expectations for what people living with MS can achieve from their therapy," said Paul Petrelli, Managing Director, Biogen Idec Canada. "TECFIDERA marks the fourth therapy we provide in Canada to treat this highly complex disease. No one is doing more for people living with MS and Biogen Idec is fully committed to delivering innovative treatments, as well as best-in-class support services for MS patients."

Data proves efficacy in two of the largest Phase III studies ever in MS
The Health Canada approval of TECFIDERA is based on data from DEFINE and CONFIRM, two global Phase III studies, involving more than 2,600 RRMS patients, as well as an ongoing extension study in which some patients have been followed for more than four years. 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. While not statistically significant, TECFIDERA showed a 21 per cent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI).7

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 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.8

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 will have access to a Regional Support Nurse in their region that will provide 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 we 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.9 When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted.10 The result of damaged myelin may be a wide variety of MS symptoms including fatigue, weakness, muscle spasms, pain, tremors, double vision, bladder and bowel dysfunction, cognitive deficits and loss of mobility, among other problems.11,12

MS is most often diagnosed in young adults, aged 15 to 40, but sometimes affects children as young as two years old.13 The course of MS is heterogeneous, but generally occurs over 30 to 40 years, and is characterized by multiple neurologic deficits, decreased quality of life14 and significant socioeconomic burden.15

Multiple Sclerosis in Canada
Canada is known for having one of the highest prevalence of MS in the world.16 Currently, more than two million people are estimated to suffer with MS worldwide,17 including between 55,000 and 75,000 Canadians. The overall weighted estimate of MS rates in Canada is 240 per 100,000 people18 causing three or more people per day to be diagnosed with MS.19

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 Thematic Messaging Document for DEFINE/CONFIRM Publications.
3 About MS - What is MS. MS Society of Canada. http://mssociety.ca/en/information/ms_what.htm
4 Multiple Sclerosis. A.D.A.M. Medical Encyclopedia. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/
5 BG-12 (dimethyl fumarate) Fact Sheet.
6 TECFIDERA PM. Page 28.
7 Thematic Messaging Document for DEFINE/CONFIRM Publications.
8 BG-12 (dimethyl fumarate) Fact Sheet.
9 "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
1 "Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
11"Managing MS Symptoms." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
12 Nicholas G. LaRocca, "Impact of Walking Impairment in multiple Sclerosis."  National Multiple Sclerosis Society 4, no.3 (2011): 190.
13 "About MS." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/default.htm.
14 Nicholas G. LaRocca, "Impact of Walking Impairment in multiple Sclerosis."  National Multiple Sclerosis Society 4, no.3 (2011): 190.
15 Hans-Peter Hartung, "Impact of mobility impairment in multiple sclerosis 1 - Healthcare professionals perspectives."  European Neurological Review: 110.
16 "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.
17 Hans-Peter Hartung, "Impact of mobility impairment in multiple sclerosis 1 - Healthcare professionals perspectives."  European Neurological Review: 110.
18 "MS Experts estimate number of Canadians with MS is 55,000 to 75,000." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/research/medmmo-prev-may_02.htm.
19 "About MS." Multiple Sclerosis Society of Canada, accessed January 6, 2012, http://mssociety.ca/en/information/default.htm.


SOURCE: Biogen Idec Canada

For further information:

or to arrange an interview, please contact:

Rick Maddalena
GCI Group (Canada)
416-486-7225
rick.maddalena@gcicanada.com