On November 11, 2016, ReproCELL and Steminent Biotherapeutics entered into a partnership to “develop and commercialize Steminent’s allogeneic stem cell therapy product, Stemchymal, in Japan.”
Based on the terms of the agreement between ReproCELL and Steminent:
- ReproCELL will get exclusive rights for the development and commercialization of Stemchymal for treating Spinocerebellar ataxia (“SCA”) in Japan
- ReproCELL will have right of first negotiation for the development and commercialization of Stemchymal for other disease indications
Japan also accelerated its position as a hub for regenerative medicine research with support from Prime Minister Shinzo Abe, who identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth. The Prime Minister has encouraged a growing range of collaborations between private industry and academic partners through an innovative legal framework approved last fall.
These regulatory changes have the potential to speed up the commercialization of cell therapies within Japan by allowing “time-limited conditional approval.” Assuming safety and probable efficacy have been demonstrated during early-stage clinical trials, companies are permitted to sell cell therapy products within Japan while continuing late-stage clinical trials.
According to the REPROCELL’s recent press release, this is the first time that REPROCELL will compete within the regenerative medicine market, within Stemchymal representing its first pharmaceutical product.
If all goes as planned, by ReproCELL and Steminent state that they will:
- Initiate clinical trials for Stemchymal in 2017
- Secure “time-limited conditional approval” in 2020
- Receive marketing approval in Japan by 2023
Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal
Under the financial terms of the agreement:
- ReproCELL will invest US$1M in Steminent as an allocation of new shares to a 3rd party
- REPROCELL will pay development milestones which will total approximately US$4M
- REPROCELL may make royalty payments during the commercialization of Stemchymal
To learn more, click here to view the full announcement issued by ReproCELL and Steminent.