EMERYVILLE, Calif., Jan. 05, 2021 (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 the closing of the settlement of patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc and completes the acquisition of the global rights to OSMOLEX ER®. As previously disclosed, the amended Royalty-Backed Loan Agreement with HealthCare Royalty Partners is now effective with the closing of the acquisition of OSMOLEX ER.
Through this acquisition, OSMOLEX ER joins the Adamas portfolio which includes GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. OSMOLEX ER (amantadine) extended-release tablets is FDA-approved for the treatment for Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. According to their Prescribing Information, neither GOCOVRI nor OSMOLEX ER are interchangeable with other amantadine immediate- or extended-release products for their respective approved indications.
“We are pleased to begin 2021 by adding OSMOLEX ER to our portfolio, broadening our presence in neurology and our ability to serve more patients,” said Neil F. McFarlane, Chief Executive Officer. “Our strategy for OSMOLEX ER is to invest in disciplined, gated execution with the primary objective for the product to become accretive in the near-term. We look forward to leveraging the unique opportunities and benefits of each therapy in our portfolio, with the growth of GOCOVRI remaining our primary focus.”
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 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
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.
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, including but not limited to, statements contained in this press release regarding Adamas’ expectations regarding the benefits to it from 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. 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.
Contact:
Media:
Sarah Mathieson
Vice President, Corporate Communications
510-450-3528
smathieson@adamaspharma.com
Investors:
Peter Vozzo
Managing Director, Westwicke
443-213-0505
peter.vozzo@westwicke.com