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Press release content from Business Wire. The AP news staff was not involved in its creation.
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Press release content from Business Wire. The AP news staff was not involved in its creation.

Adamas Announces Issuance of New Patents for GOCOVRI and ADS-4101

July 22, 2021 GMT

EMERYVILLE, Calif.--(BUSINESS WIRE)--Jul 22, 2021--

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 announces the issuance of two patents covering GOCOVRI® (amantadine) extended-release capsules: U.S. Patent No. 11,065,213 issued on July 20, 2021, and U.S. Patent No. 11,077,073, projected to issue on August 3, 2021. These two patents are the first issued in this patent family and provide additional claims covering the drug product GOCOVRI, the company’s medicine approved as the first and only drug to treat both dyskinesia and OFF motor complications in Parkinson’s patients, and methods of using GOCOVRI.

GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy, with or without concomitant dopaminergic medications and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF episodes. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia in people with Parkinson’s, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.

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With the issuance of these two patents, Adamas’ portfolio of patents for GOCOVRI now includes 17 U.S. patents across four separate patent families that will expire from 2025 to 2038. These latest patents will be listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations, commonly known as the Orange Book. Adamas previously announced settlement agreements with first filers for both available strengths of GOCOVRI, granting non-exclusive licenses from March 4, 2030, or earlier in certain circumstances.

In addition to these two new patents for GOCOVRI, Adamas recently received a new patent covering ADS-4101, its investigational drug candidate being considered for partnering opportunities. This patent, which follows two recently announced U.S. patents for ADS-4101, has been issued in Japan (Japan Patent No. 6902033), and is the first granted in a major market country outside the U.S.

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, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes.

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Taken once daily at bedtime, GOCOVRI provides an initial lag (delayed release) and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day (extended release). 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 ADS-4101

ADS-4101 is an investigational drug in development for the treatment of partial onset seizures in patients with epilepsy. ADS-4101 is a potential high-dose, modified release lacosamide capsule. Lacosamide is an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB SA/NV as VIMPAT® (lacosamide). The development program is currently paused as Adamas evaluates the potential value and options for a path forward for this candidate.

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20210722005295/en/

CONTACT: Investors:

Peter Vozzo

Westwicke

443-213-0505

peter.vozzo@westwicke.comMedia:

Sarah Mathieson

Vice President of Corporate Communications

510-450-3528

smathieson@adamaspharma.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL CLINICAL TRIALS

SOURCE: Adamas Pharmaceuticals, Inc.

Copyright Business Wire 2021.

PUB: 07/22/2021 09:15 AM/DISC: 07/22/2021 09:16 AM

http://www.businesswire.com/news/home/20210722005295/en