Calliditas Therapeutics has announced that a $5 million milestone payment from its partner Everest Medicines II Limited has been triggered as per the licensing agreement under which Everest is to develop and commercialize Calliditas’ leading drug candidate Nefecon in Greater China and Singapore.
The National Medical Products Administration (NMPA, formerly known as CFDA) has approved Everest Medicine’s IND (Investigational New Drug application) for Nefecon in China, an important step toward allowing Chinese clinical sites to recruit patients for the ongoing NeflgArd global Phase 3 trial, states the company. This is the first of a set of pre-defined development, regulatory and commercialization milestones of up to $106 million under the license agreement between Calliditas and Everest Medicines, announced in June 2019, giving Everest Medicines exclusive rights to develop and commercialize Nefecon in China, Hong Kong, Macau, Taiwan and Singapore.
Start working towards including China based clinical sites to the ongoing global Phase 3 trial
This approval will allow Everest Medicines to start working towards including China based clinical sites to the ongoing global Phase 3 trial, NefIgArd, thereby contributing to the recruitment of the 160 patients expected to be randomized during 2020 into Part B of the trial.
“This is truly exciting news. To have the NMPA approve the IND 6 months after entry into the license deal, thereby enabling a rapid route to market in China is very positive and reflects the good collaboration between the parties as well as the strong knowledge base and speed of execution by our partner Everest Medicines. We look forward to continuing our collaboration with Everest Medicines in order to bring Nefecon to patients and address the significant unmet medical need in China,” said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.
A global Phase 3 clinical trial with Nefecon
Calliditas currently is conducting NeflgArd, a global Phase 3 clinical trial with Nefecon for the treatment of patients with IgAN. The first 200 randomized patients in the ongoing study will form the basis for topline data readout expected to occur in Q4 of 2020. Based on positive results, Calliditas will submit an application for accelerated regulatory approval to the U.S. Food and Drug Administration and an application for conditional approval to the European Medicines Agency.
Photo of Renée Aguiar-Lucander