Acorda Therapeutics (ACOR) generated $543 million from Ampyra sales in fiscal 2017. The company derives most of its revenue from Ampyra.
In March 2017, the US District Court for the District of Delaware upheld Acorda’s Orange Book–listed patent for Ampyra, which is set to expire on July 20, 2018, but invalidated the company’s four other Ampyra-related patents, which were set to expire between 2025 and 2027.
Acorda has appealed the ruling on the invalidated patents, while the defendant generic manufacturers have appealed the decision upholding the patent expiring in July 2018. Unless the district court’s decision on the four invalidated patents is overturned, Acorda expects a rapid and significant decline in Ampyra sales after July 2018 due to generic competition.
After the district court’s decision, Acorda implemented corporate restructuring to reduce its cost structure and focus its resources on promising initiatives. As part of the restructuring, the company reduced its headcount by ~20%.
Inbrija is Acorda’s most advanced development program. Based on the company’s Arcus platform, Inbrija is a self-administered, inhaled formulation of levodopa for treatment during off-periods in patients with Parkinson’s disease who are taking a carbidopa or levodopa regimen.
On February 20, 2018, the FDA accepted Acorda’s new drug application for Inbrija and has set its target date under the Prescription Drug User Fee Act for October 5, 2018. Acorda has undertaken commercial preparations for the launch of Inbrija, and if it is approved, Acorda expects annual net revenue to reach over $800 million in US markets.
On March 26, 2018, the company announced that it has submitted a marketing authorization application to the European Medicines Agency for Inbrija. In the next part of this series, we’ll look at Acorda’s financial performance.