EMERYVILLE, Calif.--(BUSINESS WIRE)--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.
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.