Catalent Pharma Solutions and Adamas Pharmaceuticals Enter Into Phase 3 Clinical Trials Manufacturing Agreement for Potential New Treatment for Levodopa Induced Dyskinesia
Somerset, NJ – January 8, 2014 — Catalent Pharma Solutions, the global leader in development solutions and advanced delivery technologies for drug, biologic and consumer health products, and Adamas Pharmaceuticals Inc., today announced an agreement for Phase 3 clinical trials manufacturing of ADS-5102 (amantadine HCl) extended release capsules, an investigational treatment being developed for Levodopa-Induced Dyskinesia (LID) in patients with Parkinson’s disease.
“We believe Catalent’s capabilities make them the right choice to support execution of our upcoming clinical trials,” said Gregory T. Went, Ph.D., Adamas Chairman and Chief Executive Officer.
Barry Littlejohns, President of Catalent’s Advanced Delivery Technologies business said, “Our controlled release formulation expertise and drug delivery technologies will ultimately benefit patients with better treatments. We are pleased Adamas selected Catalent for the development and supply of ADS-5102 which, if approved, will be the first medical treatment indicated for patients with LID in Parkinson’s disease.”
About Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals is dedicated to improving the lives of those affected by central nervous system (CNS) disorders by enhancing the pharmacokinetic profiles of approved drugs to create novel treatments for use alone and as components of fixed-dose combination products. The Company is currently advancing a pipeline of aminoadamantane-based drug candidates for the treatment of Parkinson’s disease, Alzheimer’s disease, and other CNS disorders. The Phase 2/3 EASED study investigating ADS-5102 (amantadine HCl ER) for the treatment of levodopa-induced dyskinesia in Parkinson’s disease has recently been completed and met its primary endpoint. MDX-8704 (memantine HCl ER/donepezil, US) is a fixed-dose combination product candidate in late-stage investigation for the treatment of dementia associated with Alzheimer’s disease. In November 2012, Adamas entered into an agreement with Forest Laboratories, Inc. for the development and commercialization of MDX-8704 in the United States. Adamas plans to advance its product candidates through approval and to commercialize approved products in the United States through a specialty CNS sales force. For more information about Adamas, please visit www.adamaspharma.com .
Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products. With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com .