Adamas Pharmaceuticals, Inc. ADMS announced that its lead candidate ADS-5102 received orphan drug status from the FDA for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease.
We note that the FDA usually grants orphan drug status to candidates that are being developed as a potential treatment for rare diseases/conditions affecting less than 200,000 people in the U.S. This designation allows the product to enjoy a seven-year period of marketing exclusivity in the U.S., upon approval.
Moreover, Adamas Pharma is now eligible to receive tax credits for research and development costs incurred, seek study design assistance from the FDA as well as request for the reduction of certain regulatory fees.
Currently, Adamas Pharma is evaluating ADS-5102 in several phase III registration studies for levodopa-induced dyskinesia. Patient enrollment in these studies should be completed in 2015, with top-line results from the EASE LID study expected by the first quarter of 2016 followed by those from remaining studies later in 2016. Depending on the results of these registration studies, Adamas Pharma intends to submit a new drug application for ADS-5102 in 2016.
According to Adamas Pharma, no drug has yet been approved in the U.S. or Europe for the treatment of levodopa-induced dyskinesia. In this scenario, ADS-5102 has the opportunity to grab a good share of the market, if successfully developed and commercialized.
Additionally, Adamas Pharma intends to initiate a phase II study on ADS-5102 for the treatment of one or more central nervous system disorder by the end of 2015.
Adamas Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Incorporated CYTK and Acorda Therapeutics, Inc. ACOR. All these stocks carry a Zacks Rank #1 (Strong Buy).
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