Will use OSDrC Optidose technology to develop innovative drug formulation for CNS disorders
Catalent Pharma Solutions has signed an exclusive development and licensing contract with Switzerland-based development-stage biopharmaceutical company Sellas Life Sciences Group, to support the development and therapeutic reprofiling of zolpidem using Catalent's OSDrC OptiDose drug delivery technology.
Zolpidem is 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 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.
The company has patent-protected these indications, which will be developed through 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,' said Angelos Stergiou, MD, CEO & Chairman, SELLAS Life Sciences Group.