Acorda has suffered a fresh setback in its last-ditch attempt to stop a generic version of its multiple sclerosis drug Ampyra from hitting the market and eviscerating its sole significant therapeutic franchise. A federal appeals court refused to issue a temporary injunction against copycat versions of its drug until the court decides on its appeal of a district court ruling stripping away key patent protection.
The district court earlier upheld a patent that expires in 5 days. And they stripped 4 more than would have extended their branded protection out by years more.
Acorda’s shares $ACOR shed 16% of their value by mid-afternoon.
In an SEC filing today, Acorda noted:
If the Court of Appeals does not overturn the District Court’s decision by July 30, 2018, multiple generic drug manufacturers may decide to launch at-risk generic versions of Ampyra.
Acorda CEO Ron Cohen and his team have been scrambling to get ahead of the patent loss, pushing for a new drug approval for Inbrija, a Parkinson’s 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.
“Acorda remains well-capitalized; we expect to end 2018 with over $300 million in cash, even in the event of generic Ampyra launches,” the company said in a statement.
Burning cash, though, wouldn’t sit well with investors. They want revenue and profits.
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