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FAMPYRA(TM), the First Oral Treatment for the Improvement of Walking in MS, is Now Available in Canada

April 11, 2012

TORONTO, April 11, 2012 /PRNewswire/ – Today, Biogen Idec Canada announces that
FAMPYRA (fampridine sustained release tablets or fampridine SR) is now
available for prescription for patients living with multiple sclerosis
(MS) in Canada.  Health Canada approved FAMPYRA on February 10, 2012
for the symptomatic improvement of walking in adult MS patients with
walking disability (EDSS 3.5-7).(1) Walking impairment is one of the most common and disruptive
consequences of MS(2) and FAMPYRA is the first approved treatment that addresses this unmet
medical need. In clinical trials, it demonstrated efficacy in people
with all types of MS.(3)

Patients with MS consistently rate walking as the most important
function they want to maintain, regardless of what stage they are in
their disease.(4)  Walking impairment is directly associated with loss of independence,
restrictions on a patient’s ability to work and a reduction in overall
levels of household income.(5) In fact, a research survey shows that 88 per cent of sampled Canadians
living with MS report that difficulty walking affects their overall
mobility.(6)

“For patients with MS, one of the greatest areas affected in their lives
is walking.  Until fampridine SR (Fampyra), there have been no
pharmacologic agents shown to directly improve walking function in
persons with multiple sclerosis,” said Dr. Christine Short, Associate
Professor, Department of Medicine, Division of Physical Medicine and
Rehabilitation, Dalhousie University, Halifax, NS.  “As a clinician who
manages persons with multiple sclerosis, the approval of this treatment
in Canada represents a real breakthrough in our battle to help
individuals maintain independence and quality of life in the face of a
progressive neurologic disease.”

MS is an unpredictable, often debilitating disease of the central
nervous system that attacks the protective covering, or myelin, of the
brain and spinal cord, causing inflammation and damage.(7)  When this occurs, the normal flow of nerve impulses along nerve
fibres, or axons, becomes disrupted.(8)  Studies show that FAMPYRA can increase conduction along damaged nerves
and enable signals to pass down the nerve more normally, which may
result in improved walking for adult MS patients.(9)

Clinical Data Demonstrates Efficacy
The approval of FAMPYRA for the improvement of walking in adult patients
with MS was based on the results of two Phase III clinical trials:
MS-F203 and MS-F204.(10)  The primary endpoint was the responder rate based on walking speed as
measured by the Timed 25-Foot Walk (T25FW).(11)  A significantly greater proportion of patients taking FAMPYRA had
consistent improvement in walking speed when compared to placebo
(MS-F203: 34.8 per cent to 8.3 per cent, and MS-F204: 42.9 per cent to
9.3 per cent).(12) In patients who responded to therapy in the two studies, MS-F203 and
MS-F204, FAMPYRA increased their walking speed on average by 26.3 per
cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent,
respectively.(13)

“Seeing the effects of these results will have an important impact on
patients,” said Dr. Brad Stewart, Neurologist and Assistant Clinical
Professor, University of Alberta, Edmonton, Alberta.  “As mobility
impairment in MS is progressive, Fampyra is a welcomed, new treatment
to address this unmet need in the management of walking difficulties.”

Important Safety Information
The use of FAMPYRA is contraindicated in patients with a known
hypersensitivity to fampridine or any ingredient in the formulation;
currently on treatment with other forms of 4-aminopyridine,
dalfampridine or fampridine; with a history of mild, moderate or severe
renal impairment; or with a history of seizure or medically assessed as
at high risk of seizure.(14)

FAMPYRA should only be used under the supervision of a clinician
experienced in the treatment of MS and familiar with the safety and
efficacy of FAMPYRA.  The recommended dose of one sustained release 10
mg tablet twice daily, taken 12 hours apart,(15) should not be exceeded.(16)

The most common adverse events with incidence greater than or equal to
two per cent and at a rate greater than the placebo rate for FAMPYRA
were urinary tract infection, insomnia, dizziness, headache, nausea,
asthenia, back pain, balance disorder, paraesthesia, nasopharyngitis
and constipation.(17)

About FAMPYRA
FAMPYRA is a sustained release tablet formulation of the drug fampridine
(4-aminopyridine, 4-AP or dalfampridine). FAMPYRA has been developed to
improve walking in adult patients with MS.  It can be used alone or in
combination with disease modifying therapies, including
immunomodulatory drugs.(18) In MS, damaged myelin exposes channels in the membrane of axons
allowing potassium ions to leak, weakening the electrical current sent
through nerves. Studies have shown that fampridine can increase
conduction along damaged nerves, which may result in improved walking
ability. This prolonged-release formulation was developed and is being
commercialized in the U.S. by Acorda Therapeutics, Inc. under the trade
name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. Biogen
Idec licensed rights from Acorda to develop and commercialize
fampridine in all markets outside the U.S. FAMPYRA is manufactured for
Acorda under license from Alkermes Pharma Ireland Ltd.  FAMPYRA is a
trademark of Acorda Therapeutics, Inc.

About Multiple Sclerosis
Multiple sclerosis is a complex, chronic and generally progressive
disease,(19) most often diagnosed in young adults, aged 15 to 40, but sometimes
affects children as young as two years old.(20)  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(21) and significant socioeconomic burden.(22)

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.(23)(,)(24)

Multiple Sclerosis in Canada
Canada is known for having one of the highest prevalence of MS in the
world.(25)  Currently, more than two million people are estimated to suffer with
MS worldwide,(26) including between 55,000 and 75,000 Canadians. The overall weighted
estimate of MS rates in Canada is 240 per 100,000 people(27) causing three or more people per day to be diagnosed with MS.(28)

About Biogen Idec Canada Inc.
Biogen Idec Canada Inc. 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.

References:
____________________________________

(1) FAMPYRA(TM) Product Monograph. Page 3.
(2) Paul van Asch, “Impact of mobility impairment in Multiple Sclerosis 2 -
Patients’ Perspectives.”  European Neurological Review: 115.
(3) FAMPYRA(TM) Product Monograph. Page 20.
(4) Paul van Asch, “Impact of mobility impairment in Multiple Sclerosis 2 -
Patients’ Perspectives.”  European Neurological Review: 115.
(5) Paul van Asch, “Impact of mobility impairment in Multiple Sclerosis 2 -
Patients’ Perspectives.”  European Neurological Review: 115.
(6) MS Quality of Life Research IMPACT Study. 2010. Biogen Idec.
(7) “Managing MS Symptoms.” Multiple Sclerosis Society of Canada, accessed
January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
(8) “Managing MS Symptoms.” Multiple Sclerosis Society of Canada, accessed
January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
(9) FAMPYRA(TM) (Prolonged-Release fampridine tablets).  Fact Sheet.
(10) FAMPYRA(TM) Product Monograph. Page 20.
(11) FAMPYRA(TM) Product Monograph. Page 20.
(12) FAMPYRA(TM) Product Monograph. Page 20.
(13) FAMPYRA(TM) (Prolonged-Release fampridine tablets).  Fact Sheet.
(14) FAMPYRA(TM) Product Monograph. Page 4.
(15) FAMPYRA(TM) Product Monograph. Page 13.
(16) FAMPYRA(TM) Product Monograph. Page 4.
(17) FAMPYRA(TM) Product Monograph. Page 9.
(18) FAMPYRA(TM) Product Monograph. Page 27.
(19) Nicholas G. LaRocca, “Impact of Walking Impairment in multiple
Sclerosis.”  National Multiple Sclerosis Society 4, no.3 (2011): 190.
(20) “About MS.” Multiple Sclerosis Society of Canada, accessed January 6,
2012, http://mssociety.ca/en/information/default.htm.
(21) Nicholas G. LaRocca, “Impact of Walking Impairment in multiple
Sclerosis.”  National Multiple Sclerosis Society 4, no.3 (2011): 190.
(22) Hans-Peter Hartung, “Impact of mobility impairment in multiple
sclerosis 1 – Healthcare professionals perspectives.”  European
Neurological Review: 110.
(23)”Managing MS Symptoms.” Multiple Sclerosis Society of Canada, accessed
January 6, 2012, http://mssociety.ca/en/information/symptoms.htm.
(24) Nicholas G. LaRocca, “Impact of Walking Impairment in multiple
Sclerosis.”  National Multiple Sclerosis Society 4, no.3 (2011): 190.
(25) “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.
(26) Hans-Peter Hartung, “Impact of mobility impairment in multiple
sclerosis 1 – Healthcare professionals perspectives.”  European
Neurological Review: 110.
(27) “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.
(28) “About MS.” Multiple Sclerosis Society of Canada, accessed January 6,
2012, http://mssociety.ca/en/information/default.htm.

SOURCE Biogen Idec

Image with caption: “FAMPYRA(TM), the First Oral Treatment for the Improvement of Walking in MS, is Now Available in Canada (CNW Group/Biogen Idec)”. Image available at: http://photos.newswire.ca/images/download/20120411_C4432_PHOTO_EN_12120.jpg


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