FDA Recognizes Orphan Drug Exclusivity for Adamas’ GOCOVRI™
EMERYVILLE, Calif., Oct. 25, 2017 (GLOBE NEWSWIRE) — Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Drug Products (OOPD) has recognized by letter to the company the seven-years of orphan drug exclusivity for GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. On August 24, 2017, GOCOVRI was approved by the FDA and earned orphan drug exclusivity that will continue through August 24, 2024.
Based upon the FDA’s letter, we expect GOCOVRI’s orphan drug exclusivity to be additionally recognized in a future update of the Orange Book. Adamas will receive $65 million in funding from HealthCare Royalty Partners with such update, as part of the $100 million royalty-backed note the company signed in May 2017.
GOCOVRI (amantadine) extended release capsules is the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is a high-dose 274 mg amantadine taken once-daily at bedtime, which delivers consistently high levels of amantadine in the morning and throughout the day when dyskinesia is most prevalent.
For more information about GOCOVRI, including important safety information and U.S. Prescribing Information, visit www.GOCOVRI.com.
About Adamas Pharmaceuticals, Inc.
At Adamas, we believe in the power and the promise of medicines derived from a deep understanding of time-dependent biology. Our expertise lies in uncovering and mapping the relationship between disease and drug activity. From there, we strive to create medicines with therapeutic profiles that match the pattern of disease to drive a more significant and durable clinical effect. This understanding of time-dependent biological processes informs our every innovation, targeting advancement in treatment of chronic neurologic disorders. Our portfolio includes: GOCOVRI™ (amantadine) extended release capsules (previously ADS-5102), the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications; ADS-5102 in development for the treatment of multiple sclerosis walking impairment and additional indications in Parkinson’s disease; and ADS-4101, a high-dose, modified-release lacosamide in development for the treatment of partial onset seizures in patients with epilepsy. For more information, please visit www.adamaspharma.com.
Statements contained in this press release regarding expected future events are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “potentially,” “expected,” “will,” “plans” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, 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 ADS-5102 and ADS-4101, 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 August 8, 2017. 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.
Director, Corporate Communications & Investor Relations
Adamas Pharmaceuticals, Inc.