Catalent, SELLAS in Drug Development and Mfg. Pact

Catalent Pharma Solutions has entered an exclusive development and licensing agreement with Swiss-based SELLAS Life Sciences Group to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC OptiDose drug delivery technology.
 
The companies will work together to repurpose zolpidem, an imidazopyridine drug currently used for the treatment of insomnia, for the treatment of Parkinson’s Disease (PD) and the orphan indication Progressive Supranuclear Palsy (PSP). Catalent will develop a new formulation of the drug, provide clinical supplies and distribution services during development, and downstream commercial manufacturing.
 
SELLAS’ current clinical findings suggest that zolpidem may represent a promising new therapeutic approach in a variety of disorders affecting the Central Nervous System in addition to PD and PSP, including Obsessive-Compulsive Syndromes (OCS), coma, subcortical dementia, stroke and catatonia.
 
These indications for zolpidem will be developed via the FDA’s 505(b)(2) regulatory path, and will seek fast-track designation for PD, and orphan designation and potentially breakthrough therapy or accelerated approval for PSP in the U.S. and with the EMA.
 
“Catalent’s proven track record in innovative technologies for formulation and drug delivery make them an ideal partner to help bring this important therapeutic to market quickly, since current pharmacological treatments are unsatisfactory. The studies thus far suggest that zolpidem can ameliorate motor symptoms in patients with Parkinson’s Disease and Progressive Supranuclear Palsy,” commented Dr. Angelos M. Stergiou, MD, chief executive officer and chairman, SELLAS Life Sciences Group.
 
Barry Littlejohns, president of Advanced Delivery Technologies for Catalent, added, “We are excited to be collaborating with SELLAS on the therapeutic reprofiling of zolpidem. Both PD and PSP have longstanding, unmet therapeutic needs, and we are pleased to be working to bring better treatments to patients with these conditions.”