Acorda Therapeutics Statement on CHMP Positive Opinion on Marketing Authorization Application for FAMPYRA® in Europe
Recommended as Treatment to Improve Walking in Adult Patients with Multiple Sclerosis Who Have Walking Disability
Marketing Approval in Europe Would Trigger $25 Million Payment to Acorda from Biogen Idec
Press Release Source: Acorda Therapeutics On Friday May 20, 2011, 7:25 am
HAWTHORNE, N.Y.--(BUSINESS WIRE)-- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended conditional marketing authorization of FAMPYRA® (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale of 4-7). This oral therapy was developed and is commercialized by Acorda Therapeutics, Inc. in the United States under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. FAMPYRA is being developed and marketed by Biogen Idec outside the United States under a licensing agreement from Acorda.
Based on the CHMP recommendation, Biogen Idec expects that a conditional marketing authorization for FAMPYRA should be granted within 67 days.
“AMPYRA is the first and only medication indicated to improve walking in people with MS, and has been shown to be effective in all major types of MS. Many thousands of people with MS have experienced improvement in their walking ability after initiating treatment with AMPYRA, and we are pleased that the CHMP decision should soon allow patients in Europe to have access to this medication,” said Ron Cohen, M.D., Acorda’s President and CEO. “We will continue working with our partner, Biogen Idec, to make this therapy available in Europe and other markets worldwide.”
In May 2011, FAMPYRA was approved for use in Australia by the Australian Therapeutic Goods Administration (ATGA).
As part of the license agreement between Acorda and Biogen Idec, European Medicines Agency (EMA) approval in Europe triggers a $25 million milestone payment to Acorda from Biogen Idec. Acorda may receive additional payments of up to $375 million based on the successful achievement of future regulatory and sales milestones. Under Acorda’s existing agreements with Elan Pharma International Limited, a subsidiary of Elan Corporation plc, Acorda will pay Elan seven percent of the milestone payments that Acorda receives from Biogen Idec.
Acorda will also receive a double-digit royalty from Biogen Idec based on net sales of FAMPYRA in all markets outside the United States.
Under the provisions of the conditional marketing authorization for FAMPYRA, Biogen Idec will be required to provide further data to the CHMP. A conditional marketing authorization is renewable annually.
AMPYRA was approved by the U.S. Food and Drug Administration on January 22, 2010 based on safety and efficacy data from 56 clinical trials that enrolled more than 2,000 people, over 1,000 of whom were diagnosed with MS. The drug was launched commercially in the U.S. on March 1, 2010 and, as of December 2010, approximately 7,000 U.S. physicians had prescribed AMPYRA to approximately 40,000 people with MS. Acorda entered into a collaboration with Biogen Idec in June 2009 in which Biogen Idec licensed rights from Acorda to develop and commercialize fampridine in all markets outside the United States.
For more information, visit www.ampyra.com.
Important Safety Information
AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl=50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo.
The most common adverse events (incidence =2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
For full U.S. Prescribing Information and Medication Guide for AMPYRA, please visit: www.AMPYRA.com.
