FujiFilm told Asia Nikkei at the time, "The Fujifilm Holdings unit aims to start testing the therapy, aimed at patients with severe complications from leukemia treatment, in 2019, and hopes to win approval to manufacture and market the therapy in 2022. Preliminary discussions with oversight agencies are nearly complete."
https://asia.nikkei.com/Business/Companies/Fujifilm-to-put-stem-cells-to-the-test-in-leukemia-treatmentIt was also tweeted by Asia Nikkei, together with an initial incorrect date, of 2020 -
https://x.com/nikkeibiotech/status/1051669443351216129I found the original article at the time:
Source:http://heartseed.jp/pdf/20180925_iPSThis was first mentioned in FF's December 2016 presentation (link has now changed):
https://www.fujifilmholdings.com/en/pdf/investors/other/ff_presentation_20161208_001.pdfWalking down memory lane...
Anyways, with FF's support it was Japan first, then the US:
https://asia.nikkei.com/Business/Companies/Fujifilm-to-use-stem-cells-to-fight-leukemia-therapy-complicationsThe product was to be manufactured in the US, then delivered to the US:
"The MSC used in Phase 2 trials is supplied from the United States, but in the future it is also considering production at Japan Tissue Engineering (J-TEC) of the FujiFilm Group."
https://www.nikkan.co.jp/articles/view/00492098?twinews=20181016Why did it not go ahead:
- COVID restrictions in place (that's what we have been told at the time) which required inspections to/from Japan to be understaken first
- FF's change of business plan from a company taking drugs to market themselves to mostly becoming a CDMO (our agreement was with FujiFilm Holdings Corporation, not FCDI), which caused a sub-sub-license issue that slipped through for years on both sides (I mentioned it here as it unfolded https://hotcopper.com.au/threads/going-forward.4444981/page-22#post-39130019)
The reasons, whether that is the full picture - it is very likely that it isn't. But I can see some logic in the above.
Without FF's support it changed to USA first, then maybe Japan?
Whilst it might make sense from a partnering perspective, since you need an open IND in the US for any other indications to be trialled in clinics as well, I hope that there is something coming off these "Preliminary discussions with oversight agencies are nearly complete." Japan is still the shortest way to commercialisation - if you have the resources and/or right (local) partner.
(20min delay)