ADAMAS PHARMACEUTICALS,INC. (NASDAQ:ADMS) Files An 8-K Other EventsItem 8.01Other Events.
On March 13, 2018, the U.S. Food and Drug Administration’s (“FDA”) New Paragraph IV Certifications list was updated to reflect that an abbreviated new drug application (“ANDA”) seeking authorization from the FDA to manufacture, use, or sell a generic version of GOCOVRI™ (amantadine) extended release capsules, containing one or more certifications to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), was submitted to the FDA on January 16, 2018, and has been accepted for filing.
GOCOVRI is protected from entry of generic versions by orphan drug exclusivity until August 2024, and a portfolio of patents and patent applications until 2034. Thirteen issued patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) for GOCOVRI. Adamas intends to vigorously enforce its intellectual property rights with respect to GOCOVRI.
About ADAMAS PHARMACEUTICALS,INC. (NASDAQ:ADMS)
Adamas Pharmaceuticals, Inc. is a pharmaceutical company. The Company is engaged in developing medicines to manage the daily lives of those affected by chronic neurologic disorders. It offers a platform based on an understanding of time dependent biologic effects of disease activity and drug response to achieve relief without tolerability issues. It has developed a portfolio of chrono-synchronous therapies to address chronic neurologic disorders. Its first product candidate is ADS-5102, a chrono-synchronous amantadine therapy, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). It has completed Phase II proof-of-concept study of ADS-5102 in these patients. Its Phase III clinical program included three placebo-controlled trials: EASED, EASE LID and EASE LID 3. Its second product candidate is ADS-4101, an extended-release version of single-agent compound for the treatment of epilepsy (partial onset seizures).