Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it had reached an exclusive development and licensing agreement with Swiss-based development-stage biopharmaceutical company SELLAS Life Sciences Group (SELLAS), to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC® OptiDose™ drug delivery technology to optimize delivery profile and address unmet patient needs.
The collaboration will see Catalent partner with SELLAS to repurpose zolpidem, an imidazopyridine drug currently used for the treatment of insomnia, for unmet needs in the treatment of Parkinson’s Disease (PD) and the orphan indication Progressive Supranuclear Palsy (PSP). Under the terms of the agreement, Catalent will develop an innovative formulation of the drug, provide clinical supplies and distribution services during development, and downstream commercial manufacturing.
SELLAS’ current clinical findings suggest that zolpidem has a unique profile, and may represent a promising new therapeutic approach in a large 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.
SELLAS has patent-protected these indications for zolpidem, which will be developed via the FDA’s 505(b)(2) regulatory path with a view to seeking fast-track designation for PD, and orphan designation and potentially breakthrough therapy or accelerated approval for PSP in the US, as well as with the European Medicines Agency (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, CEO & 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.”