Adamas Pharmaceuticals Provides Review of 2015 and

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News Desk 2018

Jan 12, 2016 at 4:15 PM

Adamas Pharmaceuticals Provides Review of 2015 and Projected Future Milestones

EMERYVILLE, Calif., Jan. 12, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS ) today is providing a summary of 2015 corporate highlights and planned future milestones. Adamas, which is developing new medicines for chronic neurological disorders, utilizes its technology platform to improve the pharmacokinetics profiles of approved drugs, alone and in fixed-dose combinations. The company is developing ADS-5102 for two indications: levodopa-induced dyskinesia (LID), a complication associated with the treatment of Parkinson’s disease, and major symptoms associated with multiple sclerosis (MS) in patients with walking impairment. Adamas also has ADS-4101 in preclinical development for epilepsy (partial onset seizures). In addition, the company has a partnership with Allergan for two approved products, Namzaric™ and Namenda XR^® , which are marketed in the U.S. by Allergan.

“In 2015, we made significant progress throughout our business, advancing the clinical development of ADS-5102 for the treatment of LID and MS symptoms, announcing positive top-line results for EASE LID, our confirmatory Phase 3 study, and broadening our intellectual property portfolio,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “In 2016, we look forward to submitting a New Drug Application to the FDA for ADS-5102 for the treatment of LID and advancing ADS-4101 for epilepsy into clinical development.”

2015 and Recent Business Highlights

Raised net proceeds of $61.8 million through a follow on public offering of 2,875,000 shares in January 2016, which included the underwriters’ full exercise of their option to purchase 375,000 additional shares
Achieved positive top-line results in EASE LID, a Phase 3 trial for ADS-5102 in levodopa-induced dyskinesia
Completed enrollment in EASE LID 3, a Phase 3 clinical trial of ADS-5102 for the treatment of LID associated with Parkinson’s disease
Published results from EASED, the Phase 2/3 study of ADS-5102 in LID associated with Parkinson’s disease, in the peer-reviewed journal Movement Disorders
Received Orphan Drug Designation for ADS-5102 for the treatment of LID associated with Parkinson’s disease
Secured two additional U.S. patents relating to ADS-5102 (amantadine HCl). Adamas now has 11 U.S. patents issued and 15 pending relating to ADS-5102, including patents that cover osmotic delivery of amantadine for therapeutic purposes
Initiated a Phase 2 clinical trial of ADS-5102 for the treatment of major symptoms associated with MS in patients with walking impairment
Presented additional findings based on a post hoc analysis of patient diaries from EASED, the Phase 2/3 study of ADS-5102 in LID, which indicate treatment with ADS-5102 increases ON time without troublesome LID throughout the day

Upcoming Business Drivers

Adamas’ potential future business drivers include:

2016

Final Paragraph 4 settlement or trial for Namenda XR^® in the first quarter
Top-line data from the Phase 3 EASE LID 3 trial in the first half
Top-line data from the Phase 2 trial of ADS-5102 for the treatment of MS symptoms, including walking impairment, in the first half
Initiation of an ADS-4101 Phase 1 epilepsy study
Markman ruling relating to Namzaric™ in the fourth quarter
Submission of a New Drug Application to the U.S. FDA for ADS-5102 for the treatment of LID associated with Parkinson’s disease
FDA filing decision regarding ADS-5102 NDA for LID indication

2017

Potential FDA action on ADS-5102 NDA for LID indication
Pending potential approval, launch of ADS-5102 for LID
Initiation of an ADS-5102 Phase 3 MS study (pending positive Phase 2 results)
Initiation of an ADS-4101 Phase 3 epilepsy study (pending positive Phase 1 results)
Final Paragraph 4 settlements or trial for Namzaric™ in the second quarter

2018

Commencement of Namenda XR® royalties in the second quarter

Ongoing

Continued expansion of intellectual property estate relating to amantadine products and other product candidates in development

About Adamas Pharmaceuticals Adamas Pharmaceuticals, Inc. is driven to improve the lives of those affected by chronic disorders of the central nervous system. The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson's disease and for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. The company is also evaluating ADS-4101, an extended-release version of an FDA-approved single-agent compound for the treatment of epilepsy. The company's portfolio also includes Namzaric™ and Namenda XR^® , two approved products with Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan plc. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com .

Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA. Namenda XR^® is a registered trademark of Merz Pharma GmbH & Co. KGaA

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 all of the statements under the caption “Upcoming Business Drivers.” Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “would,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to research, clinical and development activities of ADS-5102 and ADS-4101, the competitive environment, and uncertainties associated with IP prosecution and litigation, as well as risks relating to Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2015. 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.

For questions, please contact: Julie Wood Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc. Phone: 510-450-3528

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