EMERYVILLE, Calif., Jan. 08, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today outlines key business priorities for 2017, in addition to providing a review of 2016 achievements.
“We expect 2017 to be a landmark year for Adamas,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “Our NDA for ADS-5102, a chrono-synchronous amantadine for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, has now been accepted for filing by the FDA, and we are preparing for potential approval and commercialization. If approved, ADS-5102 will be the first and only medicine approved to treat levodopa-induced dyskinesia in Parkinson’s disease patients, which is an existing gap in their treatment journey. Additionally in 2017, we will continue to advance our clinical development programs, including ADS-5102 in multiple sclerosis walking impairment and ADS-4101, a chrono-synchronous lacosamide therapy, for partial onset seizures in epilepsy.”
The Company’s key 2016 achievements and 2017 business priorities are summarized below.
ADS-5102 (amantadine hydrochloride) extended release capsules
ADS-5102 is a chrono-synchronous amantadine therapy for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. Over time, 90% of patients on levodopa therapy will suffer from LID, which is characterized by involuntary movements that are purposeless and unpredictable. ADS-5102 is dosed once daily at bedtime to time the delivery of drug levels of amantadine to waking hours when LID episodes are most frequent and movement control is needed most. ADS-5102 for LID has been granted orphan drug status and the New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017. Adamas is also investigating ADS-5102 for other indications, as it may have broad utility in hyper- and hypokinetic disorders.
2016 Key Achievements
- ADS-5102 for treatment of LID in patients with Parkinson’s disease
- Successful completion of Phase 3 clinical development program
- Submission of NDA for the treatment of LID in patients with Parkinson’s disease
- ADS-5102 for treatment of walking impairment in multiple sclerosis
- Successful completion of Phase 2a clinical study
- End-of-Phase 2 meeting with FDA
2017 Key Priorities
- ADS-5102 for treatment of LID in patients with Parkinson’s disease
- Potential FDA approval of NDA (Q3 ’17)
- Advancement of commercial activities and infrastructure
- Potential launch of ADS-5102 (H2 ’17)
- ADS-5012 for treatment of walking impairment in multiple sclerosis; evaluation of Phase 3 development pathway
- ADS-5102 for potential other indications; evaluation of indications earlier in the Parkinson’s disease treatment journey
ADS-4101 (lacosamide) capsules
ADS-4101 is chrono-synchronous lacosamide therapy in development for treatment of partial onset seizures in epilepsy. Lacosamide is an anti-epilepsy active ingredient previously approved by the FDA and currently marketed as VIMPAT® (lacosamide)i. ADS-4101 is designed as a once-daily, high dose lacosamide to provide a clinically meaningful and differentiated treatment option for epilepsy patients with partial onset seizures.
2016 Key Achievements
- Initiated Phase 1 clinical trial
2017 Key Priorities
- Completion of Phase 1 clinical trials of ADS-4101
- If successful, prepare for FDA meeting on clinical development pathway
- Presentation of temporal seizure pattern analysis and Phase 1 clinical trial results at an upcoming medical conference
About Adamas’ Chrono-Synchronous Therapy Platform
Adamas has pioneered a discovery platform for the development of chrono-synchronous therapies for neurologic disorders. Chrono-synchronous therapies are designed to synchronize the temporal patterns of disease with the dynamics of the drug profiles we invent without disrupting the brain’s master clock. The company’s platform delivers product candidates that time the release of high drug concentrations to manage tolerability to achieve potentially greater efficacy.
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals develops new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson's disease, multiple sclerosis, epilepsy and Alzheimer's disease. The NDA supporting ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease is under review by the FDA, and has a PDUFA date of August 24, 2017. Adamas is exploring other indications of ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas’ licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectivelyii. For more information, please visit www.adamaspharma.com.
Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts 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 the potential approval and commercial launch of ADS-5102 for treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, the potential for additional clinical development programs for ADS-5102 including walking impairment in multiple sclerosis, and the advancement of ADS-4101 in clinical development. Words such as "look forward," "on track," "expect," "potential," 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 our research, clinical, development and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and our business in general, see our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 3, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We undertake no obligation to update any forward-looking statement in this press release.
_________________________
i VIMPAT® is a trademark of UCB.
ii NAMENDA XR® and NAMZARIC® are trademarks of Merz Pharma GmbH & Co. KGaA.