Richter Signs Pact With Recordati for Marketing Cariprazine Drug

By Margit Feher

BUDAPEST--Hungary's largest drug maker Richter Gedeon Nyrt. said on Tuesday that it has signed an exclusive license agreement with Italian drug firm Recordati for marketing Richter's antipsychotic drug cariprazine to treat bipolar mania and schizophrenia in Western Europe, Algeria, Tunisia and Turkey.

Recordati will make an upfront payment on the signing of the contract, while further milestone payments will be made depending on the progress of both the regulatory procedure and the commercialization of the product, the two companies said in a joint statement. Richter will receive further sales-related royalties following the launch of the product.

Cariprazine is Richter's original product and is licensed to U.S. pharmaceuticals company Allergan in the U.S. and Canada. The product was launched in the U.S. in March 2016 under the trademark of Vraylar for the treatment of both bipolar mania and schizophrenia after the U.S. Food and Drug Administration gave its approval in September 2015.

The European Medicines Agency started the evaluation of Richter's marketing authorisation application for cariprazine for the treatment of schizophrenia in March 2016.

Under the agreement with Recordati, Richter will be responsible for conducting pediatric clinical studies of the drug, according to the Pediatric Investigation Plan, as required by the EMA's Paediatric Committee, which it will co-finance with Recordati, the companies added.

Write to Margit Feher at [e-mail]; Twitter: @margitfeher

(END) Dow Jones Newswires

August 02, 2016 02:56 ET (06:56 GMT)

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