Adamas Announces Issuance of New U.S. Patent Covering GOCOVRI™
December 18 2018 - 4:30PM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a fully-integrated
pharmaceutical company pioneering time-dependent medicines for
central nervous system (CNS) disorders, today announced that a new
patent has been issued that covers GOCOVRI™ (amantadine) extended
release capsules by the United States Patent and Trademark Office
(USPTO). Patent No. 10,154,971 (“the ’971 Patent”) claims a
method of reducing OFF time in a patient with Parkinson’s disease
and is the first patent to issue from this patent family. The USPTO
has now issued a total of 14 patents from three separate patent
families in the GOCOVRI patent portfolio, which now has patents
expiring from 2025 to 2034. The ‘971 patent will be 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 as well as OFF
in that population. GOCOVRI is a high-dose 274 mg amantadine
(340 mg amantadine hydrochloride) taken once-daily at bedtime,
which delivers high levels of amantadine upon waking and throughout
the day. Data from two pivotal, placebo-controlled Phase 3 clinical
studies in approximately 200 patients demonstrated statistically
significant reduction in dyskinesia, as well as a secondary benefit
in OFF time in patients dosed with GOCOVRI. The most commonly
observed adverse reactions with GOCOVRI were hallucinations,
dizziness, dry mouth, peripheral edema, constipation, fall and
orthostatic hypotension. For more information about GOCOVRI,
including complete safety information, please see the U.S.
Prescribing Information at www.GOCOVRI.com.
About Adamas Pharmaceuticals, Inc. Adamas’
goal is to create and commercialize a new generation of medicines
intended to lessen the burden of chronic neurologic diseases on
patients, caregivers and society using its deep understanding of
time-dependent biology. The company is focused on the commercial
launch of GOCOVRI™ (amantadine) extended release capsules
(previously ADS-5102), the first and only FDA-approved medicine 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 in that
population. The Company also continues to deliver on its pipeline
of differentiated investigational programs. Those programs include:
ADS-5102 in development for the treatment of multiple sclerosis
walking impairment; and ADS-4101, a high-dose, modified release
lacosamide in development for the treatment of partial onset
seizures in patients with epilepsy. For more information about
Adamas and its unique approach to developing medicines based on
time-dependent biology, please visit www.adamaspharma.com.
Forward-looking Statements Statements contained
in this press release regarding matters that may occur in the
future are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including but not
limited to, statements contained in this press release regarding
the potential clinical benefits of GOCOVRI or about Adamas’ ongoing
or planned clinical development programs 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 risks and uncertainties that could
cause actual results to differ from those expressed in
forward-looking statements, including risks relating to Adamas'
research, clinical, development and commercial activities relating
to GOCOVRI and ADS-5102, 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
November 1, 2018, 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.
Contacts: Media: Terri Clevenger Continuum
Health Communications 203-856-4326
tclevenger@continuumhealthcom.com
Investors: Marcy Nanus Solebury
Trout646-378-2927Mnanus@soleburytrout.com
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