Adamas Completes Acquisition of OSMOLEX ER

Adamas Pharmaceuticals announced the closing of the settlement of patent litigation with Osmotica Pharmaceutical, a subsidiary of Osmotica Pharmaceuticals 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 OSOMOLEX 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.”

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.