Adamas Reports Third Quarter 2016 Financial Results

EMERYVILLE, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced financial results for the quarter ended September 30, 2016. 

"This was a milestone quarter for the company as we prepared for and submitted our New Drug Application (NDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease in October 2016," said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc.  "We are pleased that our platform, which focuses on developing chrono-synchronous therapies, continues to provide potential treatments for patients with chronic neurologic disorders, including Alzheimer's and Parkinson's disease."

Recent and Upcoming Milestones

ADS-5102 (LID in Parkinson's disease)
  • Submitted an NDA with the U.S. Food and Drug Administration (FDA) for ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease in October 2016
  • Presented data from EASE LID 3, the confirmatory Phase 3 trial of ADS-5102 (amantadine hydrochloride) extended-release capsules for the treatment of LID in patients with PD, at the 4 th World Parkinson Congress 

ADS-5102 (multiple sclerosis walking impairment)
  • Preparations on track for an end-of-Phase 2 meeting with FDA for ADS-5102 to treat walking impairment in patients with multiple sclerosis

ADS-4101 (epilepsy)
  • Expect to initiate a Phase 1 study of ADS-4101 for the treatment of partial onset epileptic seizures in healthy volunteers in the fourth quarter of 2016

NAMZARIC ®

With our partner Forest Laboratories Holding Ltd. (a wholly owned subsidiary of Allergan plc), we:
  • Announced settlement with Amneal Pharmaceuticals related to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application seeking approval to market generic versions of NAMZARIC ®.
  • Announced a new, expanded label and announced availability of full titration kits for NAMZARIC ® (memantine HCl and donepezil HCl) for the treatment of patients with moderate to severe Alzheimer's disease who are currently taking donepezil hydrochloride 10 mg.  Adamas is entitled to receive low to mid-teens royalties starting in 2020.

Corporate
  • Appointed Michael F. Bigham, Chairman and Chief Executive Officer of Paratek Pharmaceuticals, Inc., to the Board of Directors

Third Quarter 2016 Financial Results

For the quarter ended September 30, 2016, Adamas reported a net loss of $14.4 million, or $0.66 per share, basic and diluted, compared with a net loss of $14.9 million, or $0.81 per share, basic and diluted, for the quarter ended September 30, 2015.  

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