Daiichi snaps up Japanese rights to CVD stem-cell therapy
- Japanese drugmaker Daiichi Sankyo has bought rights to market U.K.-based Cell Therapy's regenerative heart treatment in Japan, boosting the profile of the stem cell therapy company.
- Cell Therapy, founded by Nobel Prize-winner Martin Evans, will receive £12.5 million upfront from Daiichi for the Heartcel product rights.
- Heartcel involves injecting modified cells into a patient's heart tissue to repair cardiovascular scarring secondary to severe heart failure.
Daiichi's interest in Heartcel is further proof of growing interest and confidence in stem cell therapies. For Cell Therapy, the upfront money will facilitate its regulatory submission of Heartcel to the European Medicines Agency for the EU market. The company can submit Heartcel for conditional approval on the basis of promising early data, which would allow it to market the drug while still collecting further clinical results, notes FT.
Although only 11 patients with severe heart failure have received Heartcel therapy so far, all of them remain alive 36 months post-treatment with a 30% improvement in heart function.
Stem-cell research has been around for a long time. Cell Therapy founder Evans was working on stem cell work in mice back in 1981, and won a Nobel Prize for medicine for his stem cell research in 2007.
Although a great deal of progress has been made, there are still safety and efficacy challenges which need to be well vetted in clinical trials—especially considering the high rate of off-label usage and the growing trend of "stem-cell tourism."
Cell Therapy aims to have Heartcel approved by late 2017 or early 2018 in Europe and Japan, according to FT.