Elan Drug Technologies, a business unit of Elan Corporation, plc, recently issued the following statement regarding the US 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 US by Acorda Therapeutics.

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," said 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 past 6 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 to 500,000 people in the US have MS, and recent studies indicate that between 64% and 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,” said 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.

Elan Drug Technologies (EDT), a leading drug delivery company, is a business unit of Elan Corporation, plc. EDT developed the sustained-release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS (MatriX Drug Absorption System) technology. EDT offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal technology for poorly water-soluble compounds, to customized oral controlled-release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day.

Acorda Therapeutics is a biotechnology company developing therapies for MS, spinal cord injury, and related nervous system disorders. The company's products include AMPYRA (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with MS, which was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The company's pipeline includes a number of products in development for the treatment, regeneration, and repair of the spinal cord and brain.