Acorda Therapeutics, Inc. (ACOR - Free Report) announced that the FDA has approved its Parkinson's disease (PD) drug Inbrija (levodopa inhalation powder). The product is the first and the only approved inhaled levodopa for treating OFF periods in patients suffering Parkinson’s and receiving a carbidopa / levodopa regimen. Inbrija is expected to be launched during the first quarter of 2019.
The regulatory agency nod was based on data from a pivotal phase III placebo-controlled study, evaluating the safety and efficacy of Inbrija in approximately 900 patients afflicted with PD and undergoing carbidopa / levodopa regimen but still experiencing OFF periods, which means the return of Parkinson’s symptoms. The study met the primary endpoint with Inbrija demonstrating clinically meaningful improvements in motor function as measured by the UPDRS Part III in comparison to placebo.
We would like to remind investors that previously, the FDA was expected to make its decision on Inbrija in October this year. However, in September the FDA delayed its verdict by three months and set an action date of Jan 5, 2019. The FDA approval thus comes slightly earlier than expected. Inbrija is also under review in the EU with a decision expected soon.
The time line was postponed by the FDA after Acorda submitted additional information regarding chemistry, manufacturing and controls on the regulatory body’s request. The submissions were deemed a major amendment to the new drug application (NDA) and required more time to reassess.
Successful commercialization of Inbrija is critical for long-term growth at Acorda, especially as generic competition looms large on its key multiple sclerosis (MS) drug Ampyra.
Majority of Acorda’s net product revenues are drawn from Ampyra. However, sales of Ampyra have been declining of late due to competition from generic launches including Mylan's (MYL - Free Report) authorized generic version.
Acorda estimates Inbrija’s market opportunity to be more than $800 million in the United States as it will address a market with large unmet medical need.
So far this year, shares of Acorda have plunged 39.7%, underperforming the industry’s decline of 29.1%.
Zacks Rank & Stocks to Consider
Acorda currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Alexion Pharmaceuticals, Inc. and Gilead Sciences, Inc. (GILD - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion’s earnings estimates have moved 0.4% north for 2018 and 0.1% for 2019 over the past 60 days.
Gilead’s estimates have been revised 3.3% upward for 2018 and 3% for 2019 over the past 60 days.
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