Somerset, N.J. — Catalent Pharma Solutions, the leading 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."
Notes to Editors
OptiDose™ is a trademark of Catalent Pharma Solutions.
OSDrC® is a registered trademark of Sanwa Kagaku Kenkyusho Co., Ltd.
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ABOUT SELLAS LIFE SCIENCES GROUP
SELLAS Life Sciences is a Swiss-based development-stage biopharmaceutical company that acquires and develops innovative products for the treatment of various indications in cancer and the central nervous system, including orphan indications. The headquarters of the company are located near Zurich, Switzerland. Being a healthcare-oriented global group of companies, SELLAS has embraced all major aspects of the healthcare industry. SELLAS' core team is highly experienced in developing drugs and vaccines throughout all stages of the product's life cycle to the point of approval, marketing, and commercialization, pricing, and reimbursement, as well as third party out-licensing deals.SELLAS' management team has a proven track record of drug discovery and development and successful clinical trial coordination. In addition, the team has been involved in bringing previous companies to the German DAX and US NASDAQ stock markets, successful out-licensing of drug candidates, co-development, R&D partnership with big pharma and creating multiple alliances with centers of excellence to accelerate drug discovery and development. The management team has also developed cost-effective and time-efficient means of advancing drug candidates to value inflection points.Presently, SELLAS has two Phase II products to enter into clinical trials in Europe and the USA in 2014 and 2015 across five indications in cancer and CNS.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com