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Adamas Pharmaceuticals Provides Review of 2014 and Previews Upcoming Business Drivers

EMERYVILLE, Calif., Jan. 11, 2015 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today provided a recap of its 2014 achievements and a preview of its near-term priorities. Adamas, which develops new treatments for neurological disorders, utilizes its technology platform to improve the pharmacokinetic profiles of approved drugs, alone and in fixed-dose combinations. The company's diversified business model includes forming partnerships to improve existing brands and developing wholly owned products. Its partnership to improve existing brands, which is currently focused on Alzheimer's disease, is with Forest Laboratories, a subsidiary of Actavis plc. Adamas' wholly owned product portfolio includes ADS-5102, now in late-stage clinical development for levodopa-induced dyskinesia (LID), a movement disorder associated with Parkinson's disease.

"2014 was a pivotal year for Adamas, as we expanded the foundation of our business," said Gregory T. Went, Chairman and CEO. "With two approved products from our Actavis partnership and a comprehensive pivotal Phase 3 program for ADS-5102 ongoing, we expect to have an exciting and productive 2015."

Dr. Went continued, "Our robust technology platform, which enhances the pharmacokinetic properties of existing drugs, offers an approach to bring better medicines to patients more quickly. We look forward to maximizing the impact of our platform by completing our NDA-enabling studies for our first wholly owned product, expanding the indications under investigation, and commencing work on a new product line."

2014 Business Highlights

The 2014 business highlights were:

  • Announced completion of studies needed for the New Drug Application (NDA) filing of Namzaric™ by Forest, triggering a $40 million milestone payment to Adamas.
  • Reported Phase 2/3 data for ADS-5102, Adamas' proprietary long-acting capsule formulation of amantadine HCl, at multiple medical meetings. ADS-5102 met its primary endpoint in the Phase 2/3 trial and demonstrated statistically significant improvements in a number of key assessments of LID.
  • Completed its initial public offering, raising approximately $43 million.
  • Earned a $25 million milestone payment from Forest upon the FDA's acceptance of the NDA for Namzaric.
  • Initiated multiple Phase 3 studies for ADS-5102 in patients with Parkinson's disease who have LID. These studies will provide the foundation for an NDA filing.
    • EASE LID will enroll approximately 120 patients. The 26-week trial will assess the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime. The primary endpoint is a reduction in LID.
    • EASE LID 3 will enroll approximately 70 patients. The 13-week trial will assess the efficacy of a 340 mg dose of ADS-5102 administered once daily at bedtime. The primary endpoint is a reduction in LID.
    • EASE LID 2 is an open-label safety study of ADS-5102 in Parkinson's disease patients with LID.
  • Secured eight additional US patents for its increasing intellectual property portfolio in neurological disorders. Adamas now has 22 issued US patents -- 13 for its memantine products (with two additional applications pending) and nine for its amantadine products (with 16 additional applications pending).
  • Received a $30 million milestone payment from Forest for the FDA approval of Namzaric, the fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor) for the treatment of moderate to severe dementia of the Alzheimer's type.

Upcoming Business Drivers

Adamas priorities are to:

  • Complete enrollment in the Phase 3 LID program. EASE LID is expected to finish enrolling patients in mid-year 2015, and EASE LID 3 is expected to finish enrolling patients in the second half of 2015.
  • Report top-line data for Phase 3 EASE LID study around year-end 2015.
  • Begin clinical testing in the first half of 2015 of a potential new indication for ADS-5102 selected from the following areas:
    • hypokinetic movement disorders, generally characterized by decreased bodily movement or muscle rigidity, such as walking and fatigue issues associated with multiple sclerosis and walking deficits following stroke;
    • hyperkinetic movement disorders similar to LID, generally characterized by abnormally heightened, sometimes uncontrollable, movements, such as Huntington's chorea, tardive dyskinesia, and Tourette's Syndrome; and
    • neuropsychiatric disorders, such as depression, Alzheimer's disease and traumatic brain injury.
  • Continue to build an intellectual property portfolio protecting its novel inventions.

About Adamas

Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company's portfolio also includes two FDA-approved products. The first is a fixed-dose combination product, Namzaric™, and the second is a controlled-release product, Namenda XR®. Forest markets both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.

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

Namzaric™ is a trademark of Actavis, Inc. or its affiliates.

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. 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," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Such statements contained in this press release include expectations regarding the Adamas' platform, potential product indications and opportunities, the initiation, enrollment and completion of clinical trials, the establishment of additional corporate partnering and the strength and expansion of our intellectual property portfolio. 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 clinical and development activities of current and future products, delays in enrollment, the competitive environment and the effectiveness of the intellectual property portfolio, 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 4, 2014. 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.

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

Source:Adamas Pharmaceuticals, Inc.