Adamas Announces Settlement of Patent Litigation with Sandoz Inc.
January 02 2020 - 9:00AM
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to
developing and delivering medicines that make a clinically
meaningful difference to people affected by neurological diseases,
today announced that it has entered into a Settlement Agreement
with Sandoz Inc. (“Sandoz”) resolving its ongoing litigation
concerning Sandoz’s Abbreviated New Drug Application (“ANDA”)
seeking approval by the U.S. Food and Drug Administration to market
a generic version of GOCOVRI® (amantadine) Extended Release
Capsules.
“I am pleased to announce this settlement
agreement with Sandoz, which demonstrates the strength of Adamas’
intellectual property and provides both parties with certainty,”
said Neil F. McFarlane, Chief Executive Officer of Adamas
Pharmaceuticals, Inc. “With the launch of GOCOVRI still in its
early stages, this agreement facilitates our ability to maximize
the number of patients who may benefit from GOCOVRI.”
Under the settlement agreement, Adamas grants
Sandoz a non-exclusive license to make, use, sell, offer to sell
and import the products that are the subject of Sandoz’s ANDA as of
March 4, 2030, or earlier in certain circumstances, including a
potential for an accelerated license date if the unit sales of
GOCOVRI in the 12-month period ending July 31, 2025 or any
subsequent 12-month period decline by a specified percentage below
the unit sales of GOCOVRI in the year ended December 31,
2019. The agreed-upon entry date for Sandoz’s generic version
of GOCOVRI of March 4, 2030 is less than nine months prior to the
December 2, 2030 expiration of the last-to-expire patent, on which
Sandoz submitted a certification qualifying it for 180-day first
filer exclusivity.
In accordance with the Settlement Agreement, the
parties will submit a joint stipulation and order to the United
States District Court for the District of New Jersey, and the
Settlement Agreement to the U.S. Federal Trade Commission and the
U.S. Department of Justice. Upon entry of the joint stipulation and
order, this Settlement Agreement will conclude all patent
litigation brought to date by Adamas against generic pharmaceutical
companies that filed an ANDA seeking approval to market generic
versions of GOCOVRI prior to the expiration of the patents listed
in 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 Adamas Pharmaceuticals,
Inc.At Adamas, our purpose is clear: deliver innovative
medicines that make a clinically meaningful difference for
patients, caregivers and society. We are a fully-integrated
company with a growing portfolio of therapies that address a range
of neurological diseases. For more information, 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. 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’ research, clinical,
development and commercial activities relating to GOCOVRI and
ADS-5102, 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 November
7, 2019, 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:
Investors: Peter Vozzo Westwicke 443-213-0505
peter.vozzo@westwicke.com
Media: Sarah Mathieson Vice President of Corporate
Communications 510-450-3528 smathieson@adamaspharma.com
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