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Acorda loses Amprya appeal, reports Inbrija PDUFA delay

September 14, 2018 8:31 PM UTC

Acorda Therapeutics Inc. (NASDAQ:ACOR) fell $10.30 (37%) to $17.25 the week of Sept. 10 following setbacks related to multiple sclerosis drug Ampyra dalfampridine and Parkinson's disease candidate Inbrija levodopa inhalation powder (CVT-301). On Sept. 10, the U.S. Court of Appeals for the Federal Circuit upheld a 2017 district court ruling that leaves Ampyra with no patent protection against generic competition. Acorda then said on Sept. 13 that FDA extended the PDUFA date of Inbrija to Jan. 5, 2019 from Oct. 5, 2018 and requested additional CMC information.

That 2017 ruling, from the U.S. District Court for the District of Delaware, invalidated on grounds of obviousness four Orange Book-listed patents covering Ampyra, the last of which was set to expire in May 2027. The patents -- U.S. Patent Nos. 8,007,826; 8,663,685; 8,354,437; and 8,440,703 -- covered use of a 10 mg dose of the formulation to treat walking impairments in MS patients (see "Acorda Patent Challenge and Restructuring News")...

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