Acorda Therapeutics Inc. (NASDAQ:ACOR) added over $117 million in market cap on Friday following oral arguments held Thursday in its appeal of a district court ruling invalidating four of five patents for multiple sclerosis drug Ampyra dalfampridine. The biotech touched a 52-week high of $36.35 in intraday trading before settling at $30.40, up $2.50.
Last year, the U.S. District Court for the District of Delaware invalidated four Orange Book-listed Ampyra patents that cover use of a 10 mg dose of a sustained-release formulation of 4-aminopyridine (4-AP) to treat walking impairments in MS patients. The ruling shortened its U.S. patent protection to 2018 from 2027 (see BioCentury Extra, March 31, 2017).
The fifth remaining patent, U.S. Patent No. 5,540,938, has been deemed valid but it expires in July.
In Thursday's appeal, Acorda argued the court's ruling that the patents were invalid on grounds of obviousness be reversed.
President and CEO Ron Cohen told BioCentury that he hopes for a decision on the Ampyra patent appeal "in the next few months."
Cohen said if the company loses its Ampyra patents, Acorda would experience a "precipitous" loss since the drug accounts for over 90% of the company's revenue. Acorda reported $543.3 million in Ampyra sales in 2017.
Cohen said the company has been planning for "all contingencies" following the initial court ruling. This includes filing a preliminary injunction for the ‘938 patent, which could prevent generic filers from marketing their products until a final verdict in the case is decided.
A sixth Orange-Book patent was recently listed in April, but according to an SEC filing it does not entitle the company to additional statutory stay of approval under the Hatch-Waxman Act against generic manufacturers in the original suit.
The company has worldwide rights to Ampyra, a sustained-release formulation of 4-AP, from Alkermes plc (NASDAQ:ALKS).
If Ampyra generics come to market in July, Cohen said the company would focus on Parkinson's disease candidate Inbrija levodopa inhalation powder (CVT-301).
In February, Acorda said FDA accepted for review an NDA for Inbrija to treat "off" periods in PD patients receiving a carbidopa/levodopa regimen. The PDUFA date is Oct. 5.
EMA also accepted for review an MAA of Inbrija, an inhaled formulation of levodopa delivered via Acorda's Arcus inhalation technology.
Alkermes added $0.31 to $48.61 on Friday.