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 entered into an agreement to amend certain key terms of its Royalty-Backed Loan agreement (“Royalty-Backed Loan”) with HealthCare Royalty Partners (“HCR”). The key terms amended are summarized as follows:
- Revised to provide for repayment from a royalty on OSMOLEX ER® on the same terms as, and in addition to, the royalty for GOCOVRI®.
- Eliminated the potential royalty rate step-up to 17.5%, which would have occurred in 2022 if cumulative payments did not reach minimum specified levels by December 31, 2021. The 22.5% royalty rate step-up if total cumulative payments have not reached minimum specified levels as measured at December 31, 2022, remains.
- Revised prepayment provisions after a change of control provision to provide that the obligation to HCR is fully satisfied by making a prepayment sufficient to bring the cumulative payments to HCR to $175 million, if such prepayment is made on or prior to December 31, 2022, or $195 million if made thereafter.
- Extended the maturity date to March 31, 2027, if not earlier repaid.
- Added covenant requiring Adamas to maintain a minimum cash and investments balance of $25 million at all times through the term of the Royalty-Backed Loan.
- The amendment will come into effect upon closing the acquisition of OSMOLEX ER in early 2021.
“We are pleased to announce the amendment to certain key terms of our agreement with HealthCare Royalty Partners. These revisions allow us to further focus on improving our operational effectiveness to deliver our medicines to patients,” said Neil F. McFarlane, Chief Executive Officer. “We appreciate the continued partnership with HCR and believe the amendment will provide added flexibility to facilitate the growth of Adamas in line with our long-term strategy.”
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 that the amendment to the agreement with HCR will provide added flexibility to facilitate the growth of Adamas in line with its long-term strategy. 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 a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas’ research, clinical, development and commercial activities relating to GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption “Risk Factors.” In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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