Acorda desperately needs FDA nod for Parkinson's drug as Ampyra generics loom

Gavel court room lawsuit judge
An appeals court agreed with a lower court that four Acorda patents on Ampyra are invalid. (Pixabay)

Acorda has been working to protect intellectual property for its primary revenue source—multiple sclerosis drug Ampyra—but on Monday, a federal appeals court dealt the company’s ambitions a big setback. 

By a 2-1 vote, the U.S. Court of Appeals for the Federal Circuit upheld a lower court’s ruling last year that four Ampyra patents are invalid. With the decision, generics are right on the horizon, according to an analyst. The court's ruling comes as Acorda looks ahead to a much-needed FDA nod for another drug, Inbrija.

Ampyra is Acorda’s primary drug by sales; in the second quarter, the multiple sclerosis drug pulled in $150.3 million of the company's $153.3 million in revenues. The company last year lost a patent decision on the medication, and since then it's been working to adapt and reposition itself for the future. Acorda had to let go of 100 staffers after the patent decision. 

RELATED: Under threat of early Ampyra knockoffs, Acorda plans to chop 100 jobs 

Acorda CEO Ron Cohen said in a statement after the latest decision that his company believes its patents “reflected true invention and were valid.” Acorda is reviewing its options, he said, including another appeal. Meanwhile, thanks to its contingency plan, Cohen said Acorda is “well-capitalized and fully focused on the potential launch of Inbrija for Parkinson’s disease.” 

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In a note Monday, Jefferies analyst Michael Yee wrote that based on his team’s analysis, Teva and Hikma were “first to file” generics companies and have not settled with Acorda. They also boasted tentative generic approvals and could now launch their copycats, he wrote. About five other generics companies have tentative approvals and have settled with Acorda, so next steps for those companies “remain unclear,” he added.

Ampyra brought in $542 million last year. In 2018, the company has guided for net sales of $300 million to $350 million.

Inbrija, with an FDA decision date next month, could secure an FDA approval to treat Parkinson’s disease. Previously, Cohen told FiercePharma that the company doesn’t plan to lay off any sales reps due to the Ampyra IP situation. He said the staff will work on promoting Inbrija as part of a “1-to-1 transition.”