"All of it because they are related in my thesis. Control of future value (and CYPs share price) can at present be exerted through having a monopoly on manufacturing GvHD in Japan as readily as it can be controlled through intellectual property. "
How so? Please elaborate.
First of all we don't license a disease as such, we target a specific product (in this case CYP-001) for the treatment of a specific disease.
We currently pay someone to: a) provide us with the starting material (iPS cells from CDI), b) use our patented Cymerus technology to derive MSCs from iPS cells.
They both provide Goods & Services to us which we pay for.
We don't sell the product, instead provide sub-licenses to interested parties. They can use the starting material from (now) FCDI due to the pre-FujiFilm license agreement from 2014, which have been tested in our completed world-first trial and have proven to be safe - but they don't have to. We can also provide them with contacts for step b above - but we can't force them, especially since they may have different plans and instead of using "native" (if you want to call iPS derived MSCs that) MSCs, or perhaps are planning on genetically engineer their own MSCs ("trojan horse" comes to mind, which may or may not include modifications done at the iPS level). Check the apceth announcement, as it provides an example of the above: https://www.prnewswire.com/news-releases/cynata-enters-license-option-agreement-with-apceth-gmbh--co-kg-300264854.html Yes, it fell through, but it shows that FujiFilm won't /can't build up a "regenerative dictatorship" using our technology, unless they buy us out.
Of course FujiFilm has plans to use our technology to mass produce MSCs and deliver them all over the world. That however cannot happen until they buy us out as you can't force a potential Cynata sub-licensee to use FujiFilm for either/both a & b.
Instead, if they want to the CDMO for our cells and they don't want to buy us out, they would then have to advertise our cells to their clients to get paid for the manufacturing whilst we get paid license fees. In which case they well deserved to get paid for the Goods & Services provided (not by us, but the potential customer). If we then get paid some sort of kick-back on that transaction as well, I can't see a downside there.
"So I believe anything Ross says that demonstrates he has sufficient knowledge of the players (potential competitors to Fujifilm both in Japan and in the world for GvHD so CYP-001 specifically) to put together an alternative to Fujifilm even in Japan for GvHD (with or without manufacturing - but a non-Fujifilm player would need a manufacturing capability of sufficient scale from somewhere) would be to the good."
I am fairly confident he has or at least knows how to use Google.
"I suspect the reason they were willing to get cute despite that they knew CYP could go elsewhere (if there was someone else to go to) is that they didn't believe Ross could find an alternative to them to take GvHD through phase 2 and into the clinic in Japan (and then on to the rest of the world) - so they'd been relying on their home ground advantage (in manufacturing as well) with Japanese regulators (who will care about Good Manufacturing Practice at scale)."
You might be giving FujiFilm too much credit there. Whilst FF is on their way to dominate this space, they are still working out how to use their "superpowers". Why else would they partner with Takeda and making such statement: "'We are delighted to initiate this partnership applying practical use of our iPSC-derived cardiac cells with Takeda, which has abundant experience in drug development and clinical trials,' said Aiichiro Hiruma, General Manager of Regenerative Medicine Division at FUJIFILM Corporation." https://www.takeda.com/newsroom/newsreleases/2018/fujifilm-and-takeda-announce-collaboration-to-develop-regenerative-medicine-therapies-using-cardiomyocytes-derived-from-ipsc/ Given that, "relying" sounds like a very strong word for someone willing to partner up with their local rival, basically asking for help. They acquired a lot of different components in a relatively short period of time and in addition to that, iPS technology compared to first gen methods is still in its infancy.
"I believe I understand what Stewart is saying there - but a manufacturing process can be both not complex but still be expensive to scale up because of the need to show GMP to a regulator when clinical cells are being produced."
It is not too difficult to spot a "CGMP" certified manufacturer. In order to call yourself and advertise your services as that, you have to meet rather strict criteria, which are somewhat standardised. And with regulators around the world now slowly accepting e.g. P1 trials from other countries to allow moving forward with a P2 trial in their country, shows that it may not be that big of a hurdle anymore. You can find a lot of information regarding that on the MSB thread, when they started to deal with Tasly. Find details regarding the FDA CGMP standard here: https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
"I accept that - if any of those non-Fujifilm companies have an existing manufacturing presence in Japan I'd like Ross to be talking with or signalling the possibility of talking with them as alternatives (for GvHD in Japan then the world) to Fujifilm in the event that Fujifilm doesn't come to the table."
Our P1 trial took place in the UK and Australia, our cells however were manufactured by Waisman Biomanufacturing in the US. No problem with regulators. Hence I don't agree with your statement that a presence in Japan is vital to go forward with a P2 trial in Japan.
I don't see the manufacturing as nothing but a positive note and hopefully we will get an update providing further (any really) information on the extent and of course fees attached to it in due course.
CYP Price at posting:
$1.15 Sentiment: Buy Disclosure: Held
(20min delay)