Biogen, Inc. Release: FAMPYRA(TM), the First Oral Treatment for the Improvement of Walking in MS, is Now Available in Canada

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 MS² 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 life²¹ 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 people²⁷ 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:
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¹ FAMPYRA Product Monograph. Page 3.
²Paul van Asch, "Impact of mobility impairment in Multiple Sclerosis 2 - Patients' Perspectives." European Neurological Review: 115.
³ FAMPYRA Product Monograph. Page 20.
⁴Paul van Asch, "Impact of mobility impairment in Multiple Sclerosis 2 - Patients' Perspectives." European Neurological Review: 115.
⁵Paul 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 (Prolonged-Release fampridine tablets). Fact Sheet.
¹⁰ FAMPYRA Product Monograph. Page 20.
¹¹ FAMPYRA Product Monograph. Page 20.
¹² FAMPYRA Product Monograph. Page 20.
¹³ FAMPYRA (Prolonged-Release fampridine tablets). Fact Sheet.
¹⁴ FAMPYRA Product Monograph. Page 4.
¹⁵ FAMPYRA Product Monograph. Page 13.
¹⁶ FAMPYRA Product Monograph. Page 4.
¹⁷ FAMPYRA Product Monograph. Page 9.
¹⁸ FAMPYRA Product Monograph. Page 27.
¹⁹Nicholas 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.
²¹Nicholas G. LaRocca, "Impact of Walking Impairment in multiple Sclerosis." National Multiple Sclerosis Society 4, no.3 (2011): 190.
²²Hans-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.
²⁴Nicholas 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.
²⁶Hans-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

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