Catalent, SELLAS Partner

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with theSwiss-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. /p>

The collaboration will see Catalent partner with SELLAS to repurpose zolpidem, an imidazopyridine drug currently used for the treatment of insomnia, for treating Parkinson's disease (PD) and the orphan indication of progressive supranuclear palsy (PSP). Under the terms of the agreement, Catalent will develop an formulation of the drug, provide clinical supplies and distribution services during development, and downstream commercial manufacturing.

SE​LLAS has patent-protected these indications for zolpidem, which will be developed via the US Food and Drug Administrations’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).

Source: Catalent

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