Prospect Profile: Adamas Pharmaceuticals, Inc.

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Prospect Profile highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Adamas Pharmaceuticals, Inc. is a U.S. public pharmaceutical company that develops and commercializes highly engineered, controlled-release combination products with an initial focus on treatments for infectious disease and CNS disorders. As reported in the April 17, 2014 issue of the PharmSource Lead Sheet, Adamas raised $48 million in the completion of an IPO.

Corporate Highlights

  • Adamas was incorporated in Delaware in November 2000 under the name NeuroMolecular, Inc. The company changed its name to Adamas Pharmaceuticals, Inc. in July 2007.
  • Corporate Headquarters: Emeryville, California – Approximately 7,700 square feet of office space.
  • As of December 31, 2013, Adamas had 22 employees, 12 of whom were engaged in R&D activities.

Sourcing Opportunities

  • Adamas plans to use the net proceeds to fund a Phase III registration trial of ADS-5102 in levodopa-induced dyskinesia; to fund a Phase II/III study of ADS-5102 in a second CNS indication; to fund additional product development, including clinical trials; and for working capital, capital expenditures and other general corporate purposes.
  • The company currently has no manufacturing facilities and relies on third-party manufacturers to produce bulk drug substance and drug products required for clinical trials and commercialization of ADS-5102 and other product candidates if and when approval for marketing is received from regulatory authorities.
  • Adamas relies on a CMO to manufacture clinical supplies of ADS-5102 under a development agreement and does not have a long-term contract in place. The company is seeking to qualify an additional manufacturer to include in the anticipated NDA for ADS-5102.
  • The company also relies on other third parties to store and distribute supplies for clinical studies.
  • Adamas relies on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators to perform clinical trials.
  • The company currently has no sales or distribution personnel, and only limited marketing capabilities.

Business Relationships

  • In November 2012, Adamas entered into a license agreement with a wholly owned subsidiary of Forest Laboratories, which granted Forest an exclusive license in the US to develop and commercialize MDX-8704 and market Namenda XR for the treatment of moderate to severe dementia related to Alzheimer’s disease. Forest made an upfront payment of $65 million and Adamas is eligible to receive additional cash payments totaling up to $95 million upon achievement of certain development and regulatory milestones in addition to royalties on future net sales.

Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
ADS-5102 Traumatic brain injury Capsule Phase II/III Ready to initiate Phase II/III
ADS-5102 Levodopa-induced dyskinesia Capsule Phase III Plans to initiate Phase III registration trial in 2014. Plans to submit NDA in H1 of 2016.
ADS-8704 Moderate to severe Alzheimer’s dementia Capsule Phase III TBA
MDX-8704 Moderate to severe Alzheimer’s dementia Capsule – Hard Shell Filed NDA submitted
Namenda XR Moderate to severe Alzheimer’s dementia Capsule – Hard Shell Marketed by Forest TBA

 

Finances

(In $ thousands) 2013 2012
Revenues 71,095 37,471
R&D Expenditures 7,410 9,192
General & Administrative Expenditures 6,667 8,330
Total Operating Expenses 14,077 17,522
Capital Expenditures 167 24

 

Contact Information

Adamas Pharmaceuticals, Inc. Key Officers
2200 Powell Street, Suite 220 Gregory Went, PhD, CEO
Emeryville, CA 94608, USA Anthony M. Rimac, CFO
Phone: 510-450-3500 Natalie McClure, PhD, SVP, Product Development
Fax: 510-428-0519 David Chernoff, MD, Acting CMO
Web: www.adamaspharma.com

Ryan is a Senior Research Analyst at PharmSource. He holds a BS degree in biology, with a minor in chemistry and a BA degree in Spanish, from the University of North Carolina at Chapel Hill. Prior to joining PharmSource, Ryan worked as a Research Technician in the Neuroscience Center of the UNC Chapel Hill School of Medicine, and has been a named author on research publications.

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