PhIII details boost Acorda as execs rush to FDA with the clock ticking on a time bomb
Shares of Acorda got a boost after the market closed on Monday as investors got a chance to look over the detailed Phase III data for its inhaled levodopa drug CVT-301. And while we already knew that the top-line data on the primary endpoint for Parkinson’s disease were positive, it seemed to help that this late-stage therapy appears on track to arrive at the FDA later this month as company execs look to replace its big moneymaker, now poised to lose patent protection.
Failure, or even the hint of a setback here, would be catastrophic. So the p=0.009 value for a statistically significant improvement in motor function among patients experiencing OFF times was reassuring. The switch from OFF to ON— marking periods of the day when the drug is working— and staying ON at 60 minutes, a key secondary endpoint, was also positive. But the third step in the secondary review ran into trouble, with no significant change to the Unified Parkinson’s Disease Rating Scale — III at 20 minutes.
Analysts also flagged some worries about the lack of significant improvement in total OFF time, which could crimp its rollout, provided regulators offer a green light in the first place.
Acorda’s shares jumped 10% after in post-market trading.
Paul Matteis at Leerink offered a quick thumbs up:
We believe the full result – conveyed at the Movement Disorders Society Annual Meeting – supports our fairly high, 90% odds of FDA approval. Within the full data we are encouraged with what looks to be an acceptable safety profile as well as a low, placebo-like dropout rate. Secondary endpoints also mostly trend or are clearly in favor of drug – including the patient global impression of change – though the lack of difference (p-value of 0.98) on total OFF time may emerge as a subject of discussion as investors debate the size of the commercial opportunity. We model ~$278MM in CVT-301 sales in 2022E, and we expect the product to be approved in the middle of next year.
Acorda shifted to survival mode in early April after a US district court tossed four key patents on its flagship drug Ampyra, leaving it with one to stand on into next year. The company chopped 20% of its staff as it scrambles to restructure while gambling that it can field new drugs in short order.
But Acorda CEO Ron Cohen left his marketing team in place, gambling that an on-time approval would allow for a quick handoff of CVT-301 as they scramble to prevent a plunge in revenue. Ampyra provides the bulk of the company’s money.
Even with high odds of an approval, though, biotech is known for any number of snafus that can afflict the progress of a drug. And this time there’s no room for error as they stay focused on the high wire act.