Under the terms of the agreement, Recordati is obliged to make an upfront payment upon signature of the contract, and further milestone payments will be made depending on the progress of both the regulatory procedure and the commercialization of the product, Richter said. In addition, further sales-related royalties will become payable to Richter following the launch of the product.
The agreement stipulates that Richter will be responsible for conducting Pediatric Clinical Trials according to a Pediatric Investigation Plan, as required by the European Medicines Agencyʼs PDCO (Paediatric Committee), and to be co-financed with Recordati.
“We are pleased to have Recordati as our marketing partner in Western Europe, given our long-standing relationship and their approach of successfully managing the company for many decades,” said Erik Bogsch, Managing Director of Gedeon Richter Plc.
“We are very pleased with the addition of this innovative treatment for schizophrenia to our corporate pipeline,” said Giovanni Recordati, Chairman and CEO of the Italian concern.
Cariprazine was developed by Richter scientists and is licensed to Allergan (earlier Forest / Actavis), in the U.S. and Canada. Following FDA approval in September 2015, the product was launched in the U.S. in March 2016 under the trademark of VRAYLARTM for the treatment of both bipolar mania and schizophrenia. The European Medicines Agency (EMA) started the evaluation of Richter’s marketing authorization application for cariprazine for the treatment of schizophrenia in March 2016.
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