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

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 life(14) 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 people(18) 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. 
or to arrange an interview, please contact: 
Rick Maddalena GCI Group (Canada) 416-486-7225 rick.maddalena@gcicanada.com 
SOURCE: Biogen Idec Canada 
To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/April2013/09/c3619.html 
CO: Biogen Idec Canada
ST: Ontario
NI: HEA NP  
-0- Apr/09/2013 12:36 GMT
 
 
Press spacebar to pause and continue. Press esc to stop.