Blog | BioInformant

WideCells’ CellPlan Insurance is Live – 1st Sales Made to Biovault’s Base of Cord Blood Banks

January 8, 2017 By Cade Hildreth, Founder & President Leave a Comment

World first stem cell insurance plan, CellPlan, secures maiden sales agreement signaling commencement of commercial roll out.

CellPlan Limited (‘CellPlan’), which has developed the world’s first stem cell healthcare insurance plan and medical concierge service, has cemented its agreement with Biovault Technical Ltd (‘Biovault’), the UK’s largest private human tissue storage facility via a definitive agreement. CellPlan is part of London-listedWideCells Group plc, the healthcare services company focused on providing end-to-end stem cell services. [Read more…]

Webinar: iPSC-derived Cell Models for Oncology Applications

January 7, 2017 By Cade Hildreth, Founder & President 1 Comment

Human cell models to assess cardiovascular and neurological safety liabilities of cancer drugs

Webinar Sponsored by Axiogenesis.

Early prediction of drug-induced toxicity is needed in the pharmaceutical and biotechnology industries to decrease late-stage drug attrition.

Specifically, oncology drugs have become more effective in extending the lives of patients suffering from cancer. This improved prognosis, however, is giving more time for anti-cancer drugs to exert toxic effects such as cardiotoxicity, neuropathy and more. [Read more…]

Breaking – Golden Meditech Selling 65.4% Equity Stake in China Cord Blood Corporation

January 2, 2017 By Cade Hildreth, Founder & President Leave a Comment

Golden Meditech to Sell its Equity Interest in China Cord Blood Corporation Cash Consideration of RMB5.764 Billion

HONG KONG, Dec. 30, 2016 /PRNewswire/ — Golden Meditech Holdings Limited (SEHK stock code: 00801, TWSE stock code: 910801) (“Golden Meditech” or the “Company”, together with its subsidiaries, the “Group”), a leading integrated healthcare enterprise in China, announces that it entered into a sale and purchase agreement with Nanjing Yingpeng Huikang Medical Industry Investment Partnership (Limited Partnership) ¹ (“Yingpeng Huikang Fund” or the “Purchaser”) on 30 December 2016 regarding the disposal of the Company’s entire equity stake in China Cord Blood Corporation (“CCBC”) which represents 65.4% equity interest in CCBC on a fully diluted basis, for total cash consideration of RMB5.764 billion. The Company will host an extraordinary general meeting for shareholders to approve the transaction.

As part of the transaction, Golden Meditech agrees to give three years’ performance guarantee of CCBC in favour of the Purchaser. In case of earnings shortfall, Golden Meditech will compensate the Purchaser by cash in an amount to be calculated in accordance with the formula set forth in the profit compensation agreement.

[Read more…]

Regeneus and AGC Asahi Glass Partner to Develop Progenza in Japan

December 29, 2016 By Cade Hildreth, Founder & President Leave a Comment

Key Points

Regeneus collaborates with AGC Asahi Glass (AGC), a world-leading manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals, for exclusive manufacture of Progenza stem cell technology for Japanese market
Regeneus to receive US$16.5m with $5.5m upfront and US$11m in specified milestone payments
Regeneus and AGC establish 50/50 joint venture for exclusive clinical development and commercialisation of Progenza for osteoarthritis and all inflammatory conditions for Japanese market
AGC to expand its leading biopharma manufacturing business into regenerative medicine products

Sydney, Australia – 29 December 2016 – Regeneus Ltd (ASX: RGS), a clinical-stage regenerative medicine company, today announced that it has entered into a strategic collaboration and licensing agreement with AGC Asahi Glass (AGC) (TYO:5201), a world-leading manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals, for the manufacture, clinical development and commercialisation of Progenza, a patented off-the-shelf stem cell technology platform, for the Japanese market.

[Read more…]

ReproCELL and Steminent Partner to Commercialize Stemchymal in Japan

December 26, 2016 By Cade Hildreth, Founder & President Leave a Comment

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.

Up Next: How to Find a Stem Cell Clinical Trial for Your Condition?

Editor’s Note – This post was originally published on December 26, 2016 and has been updated for quality and relevancy.