Catalent and Minerva Neurosciences have entered into a long-term commercial supply agreement for roluperidone (MIN-101), an investigational compound under development by Minerva, for the treatment of negative symptoms of schizophrenia. Under the terms of the agreement, Catalent will manufacture and package the finished dose form of the drug at its facility in Schorndorf, Germany.
Negative symptoms can persist chronically throughout the lifetime of patients with schizophrenia and contribute to poor quality of life and functional outcomes. No treatment is approved to treat these symptoms in the United States. Minerva is currently conducting a pivotal Phase 3 clinical trial with roluperidone at sites in Europe and the U.S. and could potentially be the first to market.
“Launching any new drug with a partner marks the culmination of many years of hard work and having to overcome challenges, and is a milestone for a project,” said Dr. Aris Gennadios, President, Catalent Softgel & Oral Technologies. “Catalent has a proven track record in developing new treatments and bringing them to market quickly, efficiently, and in the most patient-friendly dose form; and we are pleased to partner with Minerva Neurosciences on this important potential therapy.”
“We are pleased to be working closely with our partner, Catalent, under a long-term supply agreement for a compound with the potential to treat negative symptoms, one of the leading unmet needs in schizophrenia,” said Rick Russell, President of Minerva Neurosciences.
To date, Catalent has worked with Minerva Neurosciences to undertake the tech transfer from pilot to commercial-scale production. This included analytical methods transfer and validation, process optimization, stability studies, and registration batch manufacturing; as well as packaging studies, and assessing the influence of formulation factors on the product’s critical quality attributes as required in the Quality by Design (QbD) process.