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Press Release

Adamas Announces Two Data Presentations on ADS-5102 for the Treatment of Levodopa-induced Dyskinesia (LID) at the 4th World Parkinson Congress


Posted on: 13 Sep 16

EMERYVILLE, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced details regarding two poster presentations highlighting data from EASE LID and EASE LID 3, two completed trials from the company's Phase 3 clinical program of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson's disease, to be presented at the 4th World Parkinson Congress (WPC) being held in Portland, Oregon, September 20 to 23, 2016.

Poster Presentation Details



 Title: Results of a Phase 3 Efficacy and Safety Study of ADS-5102 (amantadine hydrochloride)   
  Extended-release Capsules in Parkinson’s Disease Patients with Levodopa-induced Dyskinesia (EASE LID 3)
 Abstract Number: 1331 
 Poster Session Date: Friday, September 23 
 Poster Session Time: 11:30 AM - 1:30 PM 
 Room: Exhibit Hall B, Level 1 
 Poster Board Number: P35.20 
 Selected for Poster Tour 20: Thursday, September 22 from 5:15 PM to 6:45 PM 
 
 Title: ADS-5102 (amantadine hydrochloride) Extended-release Capsules Improves Activities of Daily  
  Living (ADLs) in Parkinson’s Disease (PD) Patients by Reducing Levodopa-induced Dyskinesia  
  (LID): A Post-Hoc Analysis from the Phase 3 EASE LID Study 
 Abstract Number: 1233 
 Poster Session Date: Friday, September 23 
 Poster Session Time: 11:30 AM - 1:30 PM 
 Room: Exhibit Hall B, Level 1 
 Poster Board Number: P35.15  

Abstracts can be viewed on the WPC 2016 website located at http://www.wpc2016.org.

ADS-5102 Phase 3 Program Overview
Adamas’ Phase 3 clinical program of ADS-5102 for the treatment of LID comprises three placebo-controlled trials: EASED, EASE LID and EASE LID 3.  These trials enrolled a total of 286 patients, of which 122 patients received a 340 mg dose of ADS-5102 once daily before bedtime for a pre-specified period of time.  In all three trials, changes in LID versus placebo were assessed by the Unified Dyskinesia Rating Scale (UDysRS): week 8 (EASED), week 12 and week 24 (EASE LID) and week 12 (EASE LID 3).  EASE LID 2, an open-label safety study open to patients from EASED, EASE LID and EASE LID 3 and to LID patients who have undergone deep brain stimulation, is ongoing.

About ADS-5102
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine hydrochloride) intended for once daily administration at bedtime.  ADS-5102 is designed to improve upon the pharmacokinetic (PK) profile of immediate-release amantadine, with the aim of enhancing efficacy without compromising the known tolerability profile.  In PK studies, ADS-5102 has been shown to achieve high plasma amantadine concentrations in the early morning that are sustained throughout the afternoon and are lower in the evening.

Parkinson’s Disease and Levodopa-induced Dyskinesia
Parkinson's disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability.  The most commonly prescribed treatments for Parkinson’s disease are levodopa-based therapies.  In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease.  Patients initially receive relief from symptoms of Parkinson’s disease for much of the day.  This period of relief is known as ON time.  As the effects of levodopa wear off, the symptoms of Parkinson’s disease return.  This is known as OFF time.  As Parkinson’s disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit.  Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect.  Over time many patients will suffer from levodopa-induced dyskinesia (LID).  As Parkinson’s disease advances, the symptoms of LID often worsen in frequency and severity.  Eventually the total time that a patient spends ON with LID can become a significant portion of his or her day.

About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is driven to improve the lives of those affected by chronic disorders of the central nervous system.  The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products.  Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease and for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment.  The company is also evaluating ADS-4101, an extended-release version of an FDA-approved single-agent compound for the treatment of epilepsy.  In addition, under a license agreement with Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan plc., the company is eligible to receive royalties from Forest on sales of Namenda XR® and Namzaric™ beginning in June of 2018 and May of 2020, respectively.  For more information, please visit www.adamaspharma.com.

Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.

The statements contained in this press release that are not historical fact, including those regarding the presentation of results from Adamas’ randomized Phase 3 EASE LID and EASE LID 3 trials are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  For a description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to the FDA’s interpretation and review of the ADS-5102 data and program, ongoing research, clinical and development activities of ADS-5102, the regulatory and competitive environment, as well as risks relating to Adamas’ business in general, see Adamas’ 10-Q filed with the Securities and Exchange Commission on August 4, 2016.  Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.  Adamas undertakes no obligation to update any forward-looking statement in this press release.

GlobeNewswire
globenewswire.com

Last updated on: 14/09/2016

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