Adamas Pharmaceuticals Announces Issuance of First US Patent for Nurelin™ (Amantadine HCl Extended Release) Program

  Adamas Pharmaceuticals Announces Issuance of First US Patent for Nurelin™
                  (Amantadine HCl Extended Release) Program

PR Newswire

EMERYVILLE, Calif., April 22, 2013

EMERYVILLE, Calif., April 22, 2013 /PRNewswire/ --Adamas Pharmaceuticals,
Inc. announced today that the United States Patent and Trademark Office
(USPTO) issued U.S. Patent No. 8,389,578 entitled "Composition and method for
treatment of neurological disease." The claims of this invention are directed
towards improved methods for treating Parkinson's disease using
extended-release amantadine, and cover key features related to the dose
strength and pharmacokinetic profile. Nurelin -  a once-daily
extended-release formulation of amantadine intended for nighttime
administration - is being evaluated in a Phase 2/3 clinical study for the
treatment of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD)
patients. The patent is set to expire in July, 2027. 

"The issuance of the first patent for our Nurelin program is an important
milestone in the development of this product, and further strengthens our
overall portfolio of modified-release aminoadamantanes patents," said Gregory
T. Went, Ph.D, Chief Executive Officer of Adamas and a co-inventor on the
patent. "Adamas' patent portfolio now includes 14 issued U.S. patents, 22
patents granted by patent authorities outside of the U.S., and multiple
pending applications covering our modified-release aminoadamantanes, used
alone and in combination with other drugs. Each of these patents is derived
from discoveries related to the tolerability of aminoadamantanes that led to
the unique PK/PD profiles of our once-daily, higher dose and once-daily
fixed-dose combination products."

To date, in addition to U.S. 8,389,578, Adamas has received numerous patents
directed to composition of matter and methods of treatment, including:

  oMethods of treatment with products having certain pharmacokinetic profiles
    of extended release memantine (8,058,291; 8,173,708; 8,283,379; 8,362,085;
  oCompositions of products having certain pharmacokinetic profiles of
    extended release memantine (8,168,209; 8,293,794; 8,327,792; 8,338,485);
  oMethods of reducing the titration of extended release memantine
    (7,619,007; 8,426,472); and
  oCompositions and methods of treating influenza with triple combination
    therapy (TCAD) (7,858,660; 7,981,930).

About Nurelin (ADS-5102)
Nurelin (ADS-5102) is a proprietary formulation of amantadine in development
for the treatment of central nervous system (CNS) disorders, including LID in
PD patients. Nurelin's pharmacokinetic profile is designed to reduce CNS side
effects associated with immediate-release forms of amantadine, while offering
potential for enhanced efficacy. The novel chronotherapeutic pharmacokinetic
profile of Nurelin is characterized by: 1) up to 2.7 times higher plasma
concentrations during the daytime hours when the motor and non-motor symptoms
of Parkinson's disease are at their peak; 2) lower plasma concentrations
overnight, which may reduce sleep disturbance and vivid dreams occasionally
associated with amantadine; and 3) a reduced initial rate of rise in plasma
concentration, which is expected to improve overall CNS tolerability relative
to immediate-release amantadine. The efficacy and tolerability of multiple
doses of Nurelin in the treatment of LID in Parkinson's disease patients is
currently being studied in a Phase 2/3 study. This study, known as EASED
(Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced
Dyskinesia), is designed to evaluate the efficacy of three dose strengths of
Nurelin for the treatment of LID, and to confirm tolerability and dosing.
Additional information about this trial may be found at

About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals is a leading developer of aminoadamantane-based
therapeutics. The company's products are designed to provide improved
tolerability, efficacy and dosing for the treatment of CNS disorders including
Alzheimer's disease, Parkinson's disease and Traumatic Brain Injury (TBI).
Adamas' three lead product candidates include MDX-8704 (memantine HCl
ER/donepezil, U.S. market) and ADS-8704 (memantine HCl ER/donepezil, ex-U.S.),
the first potential fixed-dose combination drug treatments for Alzheimer's
disease, and Nurelin™ (ADS-5102) for the treatment of levodopa-induced
dyskinesia in Parkinson's disease. In November 2012, Adamas entered into an
agreement with Forest Laboratories, Inc. for the late-stage development and
commercialization of MDX-8704 (memantine HCl ER/donepezil) in the U.S.
Adamas' commercial strategy is to advance its CNS programs through development
and U.S. launch using a specialty CNS sales force and supported by strategic
channel partners in the U.S. and outside of the U.S. For more information
about Adamas, please visit

SOURCE Adamas Pharmaceuticals, Inc.

Contact: BCC Partners, Karen L Bergman, +1-650-575-1509, or Michelle Corral,
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