A key Richter drug to be used in Western Europe

Hungary’s leading pharmaceutical company, Gedeon Richter Plc., has signed an exclusive license agreement with the international pharmaceutical group Recordati to commercialize cariprazine, a novel atypical antipsychotic in Western Europe and in Algeria, Tunisia and Turkey.

Cariprazine was discovered by Richter scientists and is licensed to Allergan (earlier Forest / Actavis) in the United States and Canada. Following its FDA approval in September 2015, the product was launched in the USA 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.

Under the terms of the agreement Recordati shall make an upfront payment upon signature of the contract, and further milestone payments shall be made depending on the progress of both the regulatory procedure and the commercialization of the product. In addition, further sales related royalties will become payable to Richter following the launch of the product.

In line with the agreement Richter shall be responsible for conducting Pediatric Clinical Studies according to the Pediatric Investigation Plan, as required by the European Medicines Agency's PDCO (Paediatric Committee) and it shall be co-financed with Recordati.