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Description of Business
6 Months Ended
Jun. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Description of Business
DESCRIPTION OF BUSINESS
Adamas Pharmaceuticals, Inc. (the “Company”) discovers and develops new medicines to treat chronic neurologic disorders. The Company’s portfolio includes:
ADS-5102: a high-dose amantadine therapy taken once-daily at bedtime.
ADS-5102 for Levodopa-Induced Dyskinesia in Patients with Parkinson’s Disease
A New Drug Application (“NDA”) for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease is under review by the Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (“PDUFA”) date, or deadline by which the FDA must review the NDA, of August 24, 2017. Levodopa-induced dyskinesia is a form of dyskinesia (abnormality or impairment of voluntary movement) associated with levodopa therapy, a drug used to treat Parkinson’s disease. If approved, the Company plans to initiate access to ADS-5102 for patients in 2017 and execute a full launch of the medicine via the deployment of sales representatives with marketing and promotional support in January 2018.
ADS-5102 for Multiple Sclerosis Walking Impairment
The Company completed a Phase 2, 4-week proof-of-concept study designed to evaluate ADS-5102 in patients with multiple sclerosis (MS) who have walking impairment, with plans to initiate a Phase 3 study in Q1 2018.
ADS-4101: an investigational high-dose lacosamide to be taken once-daily at bedtime.
ADS-4101 for Partial Onset Seizures in Patients with Epilepsy
Lacosamide is an anti-epilepsy active ingredient previously approved by the FDA and currently marketed by UCB SA/NV as VIMPAT® (lacosamide). The Company is currently conducting a multi-dose Phase 1b study designed to evaluate the tolerability and pharmacokinetic profile of three ascending doses of ADS-4101 (up to 600 mg/day) taken once-daily at bedtime compared to ascending doses of twice daily VIMPAT tablets in 24 healthy volunteers.
Namzaric® (memantine hydrochloride extended-release and donepezil hydrochloride) capsules and Namenda XR® (memantine hydrochloride) extended-release capsules.
These two commercially available medicines currently marketed by Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc (collectively, “Allergan”) in the United States for the treatment of moderate to severe Alzheimer’s disease. The Company is eligible to receive royalties on net sales of Namenda XR® and Namzaric® beginning in June of 2018 and May of 2020, respectively.
The Company was incorporated in the State of Delaware on November 15, 2000, and operates as one segment. The Company’s headquarters and operations are located in Emeryville, California.