Catalent and SELLAS Sign Exclusive Agreement
News Dec 12, 2014
Catalent Pharma Solutions has 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.”
Domainex Appoints Dr Bodo Spori as Head of Business Development for EuropeNews
Domainex Ltd, a privately-owned drug discovery services company, is pleased to announce the appointment of Dr Bodo Spori as Head of Business Development for Europe.READ MORE
Medherant Expands Team with Appointment of David Davies as Head of DevelopmentNews
Medherant Ltd, a leader in next-generation transdermal drug delivery, is pleased to announce the appointment of a new senior executive, David Davies, as Head of Development.READ MORE
Empowering Women in Technology Key to Boosting UK EconomyNews
A new report launched at London Stock Exchange for International Women’s Day, reveals the critical role women play in driving economic growth across the UK, with detailed research on 1,279 women-led companies showing a total contribution of £25.9 billion in revenue to the UK economy.READ MORE
Comments | 0 ADD COMMENT
World Congress on Clinical And Medical Microbiology
Sep 10 - Sep 11, 2018