Elan Drug Technologies issues statement on FDA approval of AMPYRA

Jan 25 2010

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA^™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA^™ will be marketed in the U.S. by Acorda Therapeutics (NASDAQ:ACOR).

“We are very proud to announce the approval of AMPYRA™ and we thank Elan for their collaboration throughout the development program for this drug. Elan’s expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA™ clinical program”

Using Elan Drug Technologies MXDAS^™ technology, AMPYRA^™ was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced. AMPYRA^™ is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS^™ technology.

“We wish to congratulate Acorda Therapeutics on the approval of AMPYRA^™, which will bring a very important and much needed therapy to the market for MS sufferers,” announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “This is the second product on which we have worked with Acorda and represents another significant milestone in our successful collaboration with them. It also marks the second product approved by the FDA in the last six months incorporating our technologies and reinforces our position of leadership in drug delivery.”

This is the first medicine approved by the FDA indicated to improve walking speed in people with MS. The approval and subsequent launch of AMPYRA^™ therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.

“We are very proud to announce the approval of AMPYRA^™ and we thank Elan for their collaboration throughout the development program for this drug. Elan’s expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA^™ clinical program,” stated Ron Cohen, MD., President and CEO of Acorda. “Elan has shared our commitment to bringing important new therapies to the market to improve the lives of people with MS throughout the decade we have worked together and we look forward to continuing to find opportunities to work together in the future.”

AMPYRA^™ will be manufactured by Elan at its Athlone, Ireland facility, based on an existing supply agreement with Acorda.