Prospect Profile: Adamas Pharmaceuticals, Inc.
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.
- 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.
- 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.
- 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.
|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|
|(In $ thousands)||2013||2012|
|General & Administrative Expenditures||6,667||8,330|
|Total Operating Expenses||14,077||17,522|
|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|