San Diego, CA, USA, August 1st, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the Clinical Trial Notification (“CTN”), submitted by their Japan partner; ReproCELL, to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for a Stemchymal® SCA Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) has been approved. This is another key milestone for Steminent’s international Stemchymal® SCA Phase II clinical development program with trials now moving ahead in Taiwan, US, and Japan. [Read more…]
San Diego, CA, USA, July 18th, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to initiate its Phase II clinical trial for polyglutamine spinocerebellar ataxia (“PolyQ SCA”) to enroll patients at clinical sites in the United States. This is a key milestone for the Company’s international Stemchymal® SCA Phase II clinical trials program. [Read more…]
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.”
ReproCELL and Steminent Partnership
In this article:
- ReproCELL in Japan
- Repro Therapeutics Advancement
- Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal
ReproCELL 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 and Regenerative Medicine
The timing of this partnership is significant because the “Act on the Safety on Regenerative Medicine” and revisions to the “Pharmaceutical and Medical device Act” took effect in Japan in 2014. There are subtle, but important differences between these two acts and how they support regenerative medicine development in Japan.
The aim of the Act on the Safety of Regenerative Medicine is to accelerate the clinical application and commercialization of regenerative products, including cell and gene therapies, as well as tissue engineered products. It covers clinical research and medical practice using processed cells and specifies the procedures required to deliver these cells to humans.
In contrast, the PMD Act introduces a regulatory framework for regenerative medicine products. It allows for conditional and time-limited marketing approval to be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety.
Time-Limited Conditional Approval
Under these new laws, once a company has demonstrated safety and basic efficiency data in humans and the cell product can be manufactured to the standards described within the Pharmaceutical and Medical Devices (PMD) Act, the cell therapy can be awarded conditional approval for up to 7 years. This allows for the commercial use of the cell product with data reporting requirements and potential for national insurance coverage.
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 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.
Repro Therapeutics Advancement
According to 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, 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.
In your opinion, how has Japan’s attitude towards regenerative medicine affected stem cell research? Share your thoughts in the comments section below.
Editor’s Note – This post was originally published on December 26, 2016 and has been updated for quality and relevancy.