Acorda Therapeutics Inc. recently announced that its patent no. 5,540,938 has been granted a five year patent term extension under the patent restoration provisions of the Hatch Waxman Act by the US Patent and Trademark Office (USPTO).
The patent is related to Acorda’s lead product Ampyra (dalfampridine, 10 mg). Post the extension, the patent will expire in 2018.
We note that in March 2010, Acorda had applied for the extension of the above-mentioned Ampyra patent based on the provisions of the Hatch Waxman Act that allow for up to five additional years of patent protection.
Ampyra was approved by the US Food and Drug Administration (FDA) in January 2010 for the improvement of walking in multiple sclerosis patients. Ampyra is available outside the US under the trade name Fampyra. Acorda has a license and collaboration agreement with Biogen Idec (BIIB - Analyst Report) for the development and commercialization of Fampyra outside the US.
Fampyra is approved in the EU, Norway, Iceland, Canada, Australia and New Zealand. Biogen has launched Fampyra in Germany, the UK, Denmark, Norway, Iceland, Canada, Australia and New Zealand and expects to launch Fampyra in most of the remaining EU countries by year end.
The company expects net Ampyra revenue in the range of $255 million to $275 million in 2012. Ampyra has the potential to be approved for additional indications as well. Acorda is currently studying Ampyra in phase II proof-of-concept studies for cerebral palsy (results by year end) and post-stroke deficits (results in early 2013).
We currently have a Neutral recommendation on Acorda.