NeuroVive Pharmaceutical said today its Asia subsidiary has signed a collaboration agreement with Sanofi to develop and commercialize CicloMulsion® in South Korea. The value of the deal was not disclosed.
Sanofi has agreed to pay NeuroVive Asia an upfront payment, a milestone payment, and royalty on potential future South Korea sales of CicloMulsion, the first cyclophilin inhibitor developed for the treatment of reperfusion injury in cardiovascular disease. The right to receive royalties under the agreement continues until the product is no longer sold in South Korea by Sanofi, NeuroVive said.
An “extensive” international program toward clinical development and commercialization of CicloMulsion, according to NeuroVive. The product is being assessed as a potential treatment of reperfusion injury following myocardial infarct in the European clinical Phase III study “CIRCUS.” The last of a total of 975 patients was enrolled in February 2014, with final results of the analysis of the 12-month data expected to be presented in the third quarter of this year.
CicloMulsion is also being evaluated for the treatment of other acute heart and kidney injuries under a collaboration with Hospices Civils de Lyon, and in a clinical Phase II study in collaboration with Skåne University Hospital in Lund, Sweden.
Additionally, a planned Asian Phase III study will be conducted by NeuroVive Asia with Sihuan Pharmaceuticals in China, and possibly other collaboration partners.
Potential positive results from the planned Asian study, alongside additional data that includes results of the current European Phase III study, will be used to seek market approval for CicloMulsion in a number of Asian countries for the treatment of reperfusion injury following myocardial infarct, NeuroVive said.
“The collaboration with Sanofi will enable us to broaden the commercialization of CicloMulsion for the treatment of cardiovascular disease. South Korea is an important market in Asia and this collaboration with Sanofi is further confirmation of CicloMulsion’s clinical and commercial potential,” Mikael Brönnegård, NeuroVive’s CEO, said in a statement.
