NorthWest Biotherapeutics Inc (NWBO)

[CogDiss 1188X]

Japanese market a missed opportunity?

Biosectinvestor, seems like we agree on the potential of the framework of the Japanese Regenerative Medicine law, combined with a Japanese pharma partnership, to accelerate the development, availability and monetization of DCVax products.

For those who might have missed it, here’s a link that gives a very high overview:
https://bioinformant.com/japan-accelerated-approvals-of-cell-therapies/

A little more detail:
https://hbr.org/sponsored/2018/02/how-japan-is-creating-new-opportunities-in-the-field-of-regenerative-medicine-2


Not sure why the Japanese partnership pathway hasn’t been used by NWBO, since dendritic cell therapies are also covered (not just stem cell therapies).

https://www.omicsonline.org/open-access/future-prospective-of-cancer-vaccination-technology-in-japan-2167-7689-1000143.pdf

https://asia.nikkei.com/Business/Technology/Immune-therapy-opens-new-paths-of-cancer-treatment


As you are aware, this path forward has done much for Athersys - it has removed the financial pressure while simultaneously allowing them to pursue more opportunities forward, for themselves, and through their partner, Healos:
https://globenewswire.com/news-release/2016/01/08/800413/0/en/Healios-and-Athersys-Enter-Into-Regenerative-Medicine-Partnership-for-Treatment-of-Stroke-Using-MultiStem-Therapy.html

This deal was extended to include more indications and upfront/milestone payments, in 2018.
http://www.athersys.com/news-releases/news-release-details/healios-receives-rights-develop-and-commercialize-additional


Since the Japanese requirements around commercialization are less stringent, Healios will finish their trial significantly before Athersys completes their phase III trial for stroke in the US.

Positive results in Japan seem very likely — given past results with Multistem for stroke combined with the need to just demonstrate safety plus probable efficacy to gain 7 years conditional approval.

I interpret the current extensions of negotiations to expand the partnership to be a sign of that Athersys has a strong hand (since Healios is paying for the privilege). I trust that ATHX is not overplaying it. Perhaps it’s due to the extent and complexity of the future deal, which includes rights to market in China.
https://finance.yahoo.com/news/healios-agrees-payment-extend-exclusive-110000703.html

BTW, I agree it is better to avoid transferring the technology to Chinese companies. Athersys is using Longa and Nikon to manufacture cells on a mass scale. The deal with Nikon was the first Nikon signed in its move into cell manufacturing (echoes of Huawei?).