New Oral Therapy Addresses Key Need for MS Community
ZUG, Switzerland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) today issued the following statement regarding the United States (U.S.) Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. The U.S. FDA approval was granted on January 22, 2010.
AMPYRA will be marketed in the U.S by Acorda Therapeutics, Inc. (NASDAQ: ACOR). AMPYRA is an extended release tablet formulation of the investigational drug dalfampridine (4-aminopyridine and called fampridine outside the U.S.). Biogen Idec will commercialize fampridine as a prolonged release tablet in markets outside of the U.S.
“For people with MS, impaired walking ability is one of the most common and concerning aspects of the disease,” said Alfred Sandrock, MD, PhD, senior vice president, Neurology Research and Development, Biogen Idec. “AMPYRA may be an important therapy in reducing the impact of this debilitating condition.”
“We congratulate our partner, Acorda Therapeutics, on this important achievement and look forward to working with regulators outside of the U.S. to make this therapy available to all people living with MS.”
On 12 January 2010, Biogen Idec announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for prolonged release fampridine tablets for the improvement of walking ability in adult patients with multiple sclerosis (MS). The company also has filed a New Drug Submission (NDS) to Health Canada.
AMPYRA is an extended release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). Extended release fampridine tablets act by blocking the potassium channels in demyelinated nerves, which reduces the leakage of current from the axons, restoring neuronal conduction, and action potential formation.
This tablet formulation was developed and commercialized in the U.S. by Acorda Therapeutics. Biogen Idec will commercialize fampridine as prolonged release tablets in markets outside of the U.S.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
This press release contains forward-looking statements, including statements about the anticipated timing of regulatory filings. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those that we expect, including the uncertainty of obtaining regulatory approval, the occurrence of adverse safety events with our products, our dependence on collaborations over which we may not always have full control, and the other risks and uncertainties that are described in Item 1.A. Risk Factors in our annual report on Form 10-K and in other reports we file with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Shannon Altimari, +41 41 392 1677
Manager, Public Affairs
John Applegate, +1 617-679-2812
Associate Director, Investor Relations