Mesoblast (MESO) said Wednesday morning it is planning to apply for conditional and full product approvals with Japanese regulators for a number of products, including a heart failure drug which is currently in a phase 3 trial.
Mesoblast CEO Silviu Itescu held a presentation on the company’s strategy for the Japanese market at a Australia-Japan Joint Business Council meeting, held in Melbourne October 9-11, it said in a statement on Wednesday.
Mesoblast’s most advanced product candidate, MPC-150-IM, has blockbuster potential for the treatment of heart failure, could meet criteria for conditional approval under new legislation as well as for full approval, the company said.
MPC-150-IM is currently in an advanced phase 3 trial in North America with interim results due in Q1. Results from this trial could support Japanese regulatory filings and product launch, in conjunction with data in a limited number of Japanese patients.
Mesoblast said it was having talks with potential commercial partners for the Japanese and global heart failure markets.
The number of people having heart failure in Japan in 2016 is estimated at 1.45 million, with the annual direct medical cost for heart disease amounting to 800 billion yen.
The comapny’s partner JCR Pharmaceuticals began selling Temcell injections in February in Japan. The drug is the first allogeneic cell-based medicine to receive full regulatory approval in Japan. Mesoblast is getting royalties and other payments at pre-defined thresholds of cumulative net sales, it said.