Adamas announces issuance of new U.S. patent for GOCOVRI in Parkinson’s disease - expands coverage with reduction of ‘OFF...
May 13 2020 - 9:15AM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a meaningful
difference to people affected by neurological diseases, today
announced it has been issued a new patent (no. 10,646,456) by the
United States Patent and Trademark Office (USPTO) that covers
GOCOVRI® (amantadine) extended release capsules. The new patent
covers a method of reducing ‘OFF’ time and increasing ‘good ON’
time (ON time without troublesome dyskinesia) in people with
Parkinson’s disease (PD) being treated with levodopa. GOCOVRI
is indicated for the treatment of dyskinesia in patients with
Parkinson’s disease receiving levodopa-based therapy, with or
without concomitant dopaminergic medications. Data from two
pivotal, placebo-controlled phase 3 clinical studies showed that
GOCOVRI reduced dyskinesia, as well as a secondary benefit in
reduction of OFF time, leading to an increase in good ON time.
This is the second patent to be issued for
GOCOVRI that covers reduction in OFF time and will expire in 2034.
Adamas’ portfolio of patents for GOCOVRI now includes 15 U.S.
patents, across three separate patent families that will expire
from 2025 to 2034. This latest addition is listed in the U.S. Food
and Drug Administration’s (FDA) Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the Orange
Book.
About
GOCOVRI®GOCOVRI® (amantadine) extended-release
capsules is the first and only FDA-approved medicine indicated
for the treatment of dyskinesia in patients with Parkinson’s
disease receiving levodopa-based therapy, with or without
concomitant dopaminergic medications. It is also the only medicine
clinically proven to reduce both dyskinesia and OFF. Taken once
daily at bedtime, GOCOVRI provides an initial lag and a slow rise
in amantadine concentration during the night, resulting in a high
concentration from the morning and throughout the waking day.
Additionally, in the clinical trials, the adjunctive use of GOCOVRI
did not require dose changes to dopaminergic therapies. The
most commonly observed adverse reactions with GOCOVRI were
hallucinations, dizziness, dry mouth, peripheral edema,
constipation, falls and orthostatic hypotension.
For more information about GOCOVRI, please visit
www.GOCOVRI.com.
About Parkinson’s Disease, Dyskinesia
and OFFParkinson’s Disease (PD) is a progressive,
neurodegenerative disorder caused by the gradual loss of brain
cells that produce the neurotransmitter dopamine and affects
approximately one million people in the United States. Dopamine
decline in the brain results in a wide range of motor
(movement-related) and non-motor symptoms. As the disease
progresses, people are likely to experience unpredictable
stiffness, rigidity and tremors, referred to as OFF time. The
primary treatment for PD is with levodopa; however, over time
levodopa may lead to involuntary, uncontrolled movements known as
dyskinesia. The abrupt and unpredictable transitions between
episodes of dyskinesia, normal movement and OFF time lead to
considerable impact on patients’ lives.
About Adamas
At Adamas our vision is clear – to deliver
innovative medicines that reduce the burden of neurological
diseases on patients, caregivers and society. We are a
fully-integrated company focused on growing a portfolio of
therapies to address a range of neurological diseases. For more
information, please visit www.adamaspharma.com.
Forward-looking
statementsStatements contained in this press release
regarding matters that may occur in the future, including the
expectations as to the long-term benefits of GOCOVRI, are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements are
subject to risks and uncertainties, and actual results may differ
materially from those expressed or implied by such forward-looking
statements. For a description of risks and uncertainties that could
cause actual results to differ from those expressed in
forward-looking statements, including risks relating to Adamas’
commercial activities relating to GOCOVRI, and the regulatory and
competitive environment and Adamas’ business in general, see
Adamas’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 7 2020, particularly under the caption
“Risk Factors.” 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, except as required
by law.
Contact:
Media:Sarah MathiesonVice President of Corporate
Communications510-450-3528smathieson@adamaspharma.com
|
Investors:Peter VozzoManaging Director,
Westwicke443-213-0505peter.vozzo@westwicke.com
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