Adamas Announces Settlement of Patent Litigation with Zydus
February 01 2021 - 8:01AM
Business Wire
- Adamas grants Zydus license for generic
version of GOCOVRI® as of March 4, 2030 -
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 Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc.
(“Zydus”) resolving its ongoing litigation concerning Zydus’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 the swift settlement of this
litigation which reaffirms the strength of our intellectual
property and gives us confidence in the opportunity to deliver
GOCOVRI to the patients who may benefit for years to come,” said
Neil F. McFarlane, Chief Executive Officer. “We are focused on
building on the momentum from our strong 2020 performance and
delivering growth for GOCOVRI in 2021.”
Under the settlement agreement, Adamas grants Zydus a
non-exclusive license to make, use, sell, offer to sell and import
generic versions of GOCOVRI 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.
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.
Source: Adamas Pharmaceuticals, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210201005295/en/
Investors: Peter Vozzo Managing Director, Westwicke 443-213-0505
peter.vozzo@westwicke.com
Media: Sarah Mathieson Vice President, Corporate Communications
510-450-3528 smathieson@adamaspharma.com
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