Mitsubishi Tanabe Pharma Corporation's subsidiaries in the ASEAN region obtained the regulatory approval of cariprazine for the treatment of schizophrenia in Singapore and in Thailand, Richter announced today on the Budapest Stock exchange website.
Under the terms of the agreement, Richter will supply the drug and MTPC through its subsidiaries will be responsible for the distribution of the product in the two markets. Richter will be entitled to regulatory-related milestone payments and sales-related royalties.
"We are pleased with this very recent regulatory development, which by taking cariprazine to ASEAN represents a further step down the road of making cariprazine available worldwide for those who are suffering from schizophrenia," said Gábor Orbán, CEO of Richter.
Cariprazine was discovered and has been co-developed by Gedeon Richter with U.S.-based Forest (now Allergan) since 2005. It is used in the treatment in bipolar depression, major depression, bipolar mania and schizophrenia. Cariprazine is licensed by Allergan, in the U.S. and in Canada, where it is sold under the Vraylar brand name since 2015 after Stage 3 clinical trials for the main indication, schizophrenia, closed successfully.
Richter has been marketing the drug in the European Union since May 2017 under the Reagila name. Royalties after Vraylar amounted to EUR 75.9 million in 2018 and Reagila sales totalled EUR 2.8 million. The EUR 78.7 million combined income from cariprazine represented 5.6% of Richter's revenue last year.