Acorda Files Parkinson's Drug Marketing Application In EU

Acorda Therapeutics, Inc. (NASDAQ:ACOR) announced the filing of Marketing Authorization Application (“MAA”) for its Parkinson’s candidate, Inbrija (levodopa inhalation powder) with the European Medicines Agency (“EMA”).

The company is seeking approval for Inbrija as a treatment option for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen.

A similar application is under review in the United States with a decision expected in October 2018.

Following the news, shares gained about 6.1%. So far this year, the stock has returned 13.1% against the industry’s decline of 5.9%.

The MAA filing was based on data from a phase III SPAN-PD study and two long-term safety studies evaluating Inbrija in patients with Parkinson’s disease who are on a carbidopa/levodopa regimen. The candidate achieved statistically significant improvement in motor function in patients experiencing OFF periods.

However, we remind investors that Acorda’s Parkinson’s disease pipeline candidates faced setbacks in 2017.

In November 2017, Acorda discontinued the phase III study on one of its lead Parkinson’s disease candidates, tozadenant. The decision was based on some serious safety issues observed in the study.

In August, the FDA issued a refusal to file letter for the first new drug application (“NDA”) for Inbrija filed in June. The FDA considered the NDA to be incomplete and requested data for date specification as to when the manufacturing site can be ready for inspection and questions related to drug master production record. Acorda has resubmitted the NDA with the requested data in December 2017, which was eventually accepted by the FDA in February this year.

Per the company’s press release, around one million people in the United States and 1.2 million in Europe are diagnosed with Parkinson’s disease. Among them, OFF periods are experienced by approximately 350,000 people in the United States and 420,000 in Europe. Hence, the market potential to address the unmet need is huge in this area.

However, apart from Acorda, many companies are trying to introduce treatments for Parkinson’s disease in the market namely, Prothena Corporation’s (NASDAQ:PRTA) PRX002, AstraZeneca’s (NYSE:AZN) MEDI1341 and Prexton Therapeutics’ Foliglurax.

Also, Adamas Pharmaceuticals (NASDAQ:ADMS) launched Gocovri in January 2018 as the first approved treatment for dyskinesia in patients with Parkinson’s disease in the United States.

Zacks Rank

Acorda carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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