Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone
SOMERSET, N.J. and Waltham, Mass. – September 24, 2019 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, and Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that they 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,” commented Dr. Aris Gennadios, President, Catalent Softgel & Oral Technologies. He added, “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 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.
Notes for Editors
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists, at more than 35 facilities across five continents, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
ABOUT MINERVA NEUROSCIENCES, INC.
Minerva Neurosciences, Inc. (NASDAQ: NERV), is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: Roluperidone (MIN-101), in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com