ELAN DRUG TECHNOLOGIES WELCOMES THE LAUNCH OF MS DRUG AMPYRATM (DALFAMPRIDINE) EXTENDED RELEASE TABLETS
DUBLIN, IRELAND, March 1, 2010, Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the launch in the U.S. of AmpyraTM (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AmpyraTM is marketed in the U.S. by Acorda Therapeutics (NASDAQ:ACOR).
"We are delighted to see the launch of AmpyraTM in the US following its approval earlier this year. AmpyraTM which incorporates one of our drug delivery technologies is being manufactured at our facility in Athlone, Ireland", announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "We wish Acorda every success in getting this important product to the many patients in the US that have walking difficulties as a result of their MS"
Using Elan Drug Technologies MXDASTM technology, AmpyraTM 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. AmpyraTM is the first New Drug Application (NDA) approved and now launched for a product using the MXDASTM technology.
This is the first medicine indicated to improve walking speed in people with MS. The launch of AmpyraTM 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.
AmpyraTM will be manufactured by Elan at their Athlone, Ireland facility, based on an existing supply agreement with Acorda
AmpyraTM is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AmpyraTM, was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AmpyraTM was developed using Elan Drug Technologies Oral Controlled Release MXDASTM(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. AmpyraTM is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.
About Elan Drug Technologies
Elan Drug Technologies (EDT) a leader in drug delivery 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 MXDASTM (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised 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. More information is available at www.elandrugtechnologies.com
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include AmpyraTM (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this 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.
AmpyraTM and Zanaflex Capsules® are trademarks of Acorda Therapeutics Inc
MXDASTM and NanoCrystal® are trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN).
Safe Harbour/Forward-Looking Statements
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.