Takeda Pharmaceutical Co. Ltd. (Takeda) is reportedly preparing to offer “stem cell therapy” in Japan as early as fiscal 2021. The Tokyo-based company aims to obtain approval and start production of the drug that uses stem cells and improves the patient’s immune function to fight against an intractable disease which causes inflammation, for example in the intestines. While European and American manufacturers are currently leading the way in stem cell therapy for cancer treatment and other areas, Takeda will establish a supply system of the drug deemed promising as next-generation medicine in Japan to provide a new option for patients, the Nikkei recently reported.
Takeda has invested about 1 billion yen in its plant in Osaka City to install clean rooms and equipment for cell culture in order to produce the stem cell drug "darvadstrocel". The company has established a system to produce the drug for 600 - 700 patients a year for obtaining approval, according to the news report.
The drug is for Crohn's disease, an intractable disease which causes inflammation and ulcers in the intestines and other parts of the body for yet unknown reasons. The disease is common among young people, and it is estimated that there are more than 40,000 patients in Japan. The drug would be administered in case of complications such as anus or rectum cells being damaged or punctured due to inflammation.
The main ingredient of darvadstrocel is the "mesenchymal stem cells" that exist in the body and can transform into various tissues. They are taken from the body fat of others and cultured. It is used as a liquid drug which is injected into the affected area.
Stem cells promote the expression of proteins which regulate the immune function. Administration of darvadstrocel increases the number of cells suppressing inflammation and decreases the number of cells causing inflammation. It is considered to improve the condition of the affected area and help the patient's cells to regenerate.
The technology was originally owned by a Belgian biopharmaceutical manufacturer, TiGenix NV. Takeda has been developing the drug in collaboration with TiGenix since 2016, and it was approved in Europe in 2018 and is marketed under the name “Alofisel". Currently, Takeda has a factory in Spain and can produce the drug for 1,000 - 1,500 patients in Europe a year.
As demand is growing, Takeda also plans to increase supply in Europe by investing approximately 3.7 billion yen in a plant in Ireland to expand the manufacturing base from 2021. Cell therapy products are required to be fresh, and darvadstrocel must be administered within 72 hours of production.