Shares of Acorda Therapeutics $ACOR tanked mid-day Monday after the biotech put out the word that a federal appeals court voted 2-to-1 to uphold an earlier court ruling invalidating their patents on their sole cash cow Ampyra.
And it hurt.
The stock immediately slid more than 20% on the news, which opens the door to cheap generic competition.
The ruling leaves Acorda wide open to seeing its only major drug on the market attacked by generics that have the potential for immediately carving away its market. Given the earlier court loss, Acorda had set in motion a restructuring as it sought to hustle ahead with a new drug.
The strategy was to switch the sales team from Ampyra to Inbrija over the summer, but that plan was at least temporarily derailed by the FDA’s initial decision to refuse to file the application last summer. Acorda now has a PDUFA date of October 5, with the company’s fate hanging in the balance.
Jefferies’ Michael Yee says the competition could arrive soon.
The court previously also rejected a temporary injunction as well. Based on our analysis, at least 2 companies (Teva and Hikma/Roxane) that were classified as “first to file” had not yet settled and had tentative FDA approvals of generic Ampyra so could launch, in our view. We count at least 5-6 that had approvals but had previously settled so those remain unclear as to next steps.
“We are disappointed by the Court’s decision, as we continue to believe that our AMPYRA patents reflected true invention and were valid. We are reviewing the decision and will consider future options, including the possibility of a further appeal,” said Acorda CEO Ron Cohen.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 37,600+ biopharma pros who read Endpoints News by email every day.Free Subscription