Agreements

Date: 2016-08-02

Type of information: Licensing agreement

Compound: cariprazine

Company: Recordati (Italy) Gedeon Richter (Hungary)

Therapeutic area: CNS diseases - Mental diseases

Type agreement: licensing

Action mechanism: dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and adjunctive MDD in adults. Cariprazine is licensed to Actavis, now Allergan, in the U.S. and Canada. Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar in the US for the treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adults.

Disease: schizophrenia, bipolar disorder

Details:

• • On August 2, 2016, Recordati and Gedeon Richter today announced the signing of an exclusive license agreement to commercialize cariprazine, a novel atypical antipsychotic in Western Europe and in Algeria, in Tunisia and in Turkey. 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.

Financial terms: 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.

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