EMERYVILLE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) — 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 announced it has signed an agreement to settle its ongoing patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc. As a result of this agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER® for $7.5 million. The agreement is expected to close early in 2021.
Adamas’ current portfolio consists of GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy. OSMOLEX ER (amantadine) extended-release tablets is FDA-approved for the treatment for Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.
“This settlement agreement removes any further litigation costs and related distraction for Adamas. The acquisition of OSMOLEX ER also expands our presence in Neurology which is part of our long-term growth strategy,” said Neil F. McFarlane, Chief Executive Officer. “The different FDA-approved indications and pharmacokinetic profiles for GOCOVRI and OSMOLEX ER allow for the treatment of distinct patient populations. We intend to leverage our commercial expertise to unlock the full potential of both products and serve more patients in the wider neurology community.”
As part of the acquisition, Adamas will receive existing inventory and all rights to OSMOLEX ER. Parties also entered a supply agreement in which Osmotica will be the sole manufacturer of OSMOLEX ER. Both parties are working together to ensure continuity of product supply to patients.
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 OSMOLEX ER®
OSMOLEX ER®, (amantadine) extended-release tablets, is FDA-approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.
For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com
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.
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 Adamas’ expectations regarding the expected timing of the closing of the transaction with Osmotica. 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 example, the completion of the transaction is subject to closing conditions, which if not met or waived, would cause the transaction not to close. Other risks relating to Adamas may be found in Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, 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.
Vice President of Corporate Communications
Managing Director, Westwicke