If Shiseido Decides to Do So

I used to cover Replicel (Canada) and its Japanese cosmetics behemoth partner Shiseido at least a few times per year until last year. At some point, I got skeptical about the RCH-01 autologous cell therapy hair loss product being released any time soon.

Shiseido LogoBesides typical delays, Replicel and Shiseido had some unclear conflicts regarding their partnership.

However, Replicel published two important updates this month, the second of which is of most interest to us:

Per the first link above, the disagreement regarding the agreement between Shiseido and Replicel remains unresolved. However, it is not subject to any litigation or arbitration at this time.

The key money quote is from the second link:

“While the Company’s RCH-01 product for hair loss due to androgenic alopecia may be launched in Japan much earlier if Shiseido decides to do so, current planning anticipates the potential for all four products to be on the market in Japan by 2022.”

The implication seems to be that:

  1. Shiseido could release the product well before 2022. See my past post on Shiseido’s new research facility in Kobe, Japan.
  2. Even if Shiseido does not release the product earlier, it will quite possibly get released in 2022 in Japan by Replicel.

See my past post on Japan’s new laws fast-tracking stem cell therapies and clinical trials.

Another key quote:

“Unlike anywhere else in the world, one well-designed cell therapy trial in Japan, approved by their regulatory authorities, has the potential to lead to product market launch.”

Replicel is clearly focusing on a “First-in-Japan” strategy due the country’s favorable regulatory environment. Shiseido has rights to the Asian market when it comes to RCH-01, but it seems like Replicel can still release the product in Japan in 2022 if Shiseido does not do so?

Hard to make this conclusion for certain without knowing much more about the two companies’ legal contract. In any case, this is a great development.

Further references:

Shiseido discusses Replicel technology in two videos.

Shiseido and Adenosine.

36 thoughts on “If Shiseido Decides to Do So”

  1. Interesting, but if Shiseido chooses not to release it prior to Replicel (2022) wouldn’t one assume it’s not very effective ?
    If it’s a home run or even a significant improvement over what we have now , Shiseido would make a killing and would want to cash in right away prior to other companies in the industry also working on similar solutions .
    Something doesn’t add up !

  2. Shiseido is a cosmetic company. They’re in the business of selling something you need to use again and again every day. Replicel is marketing an injection process that improves your hair, not something you can do at home indefinitely for a moderate cost. That seems to be the disconnect. Shiseido wanted to see if they could somehow turn the injections into an every-day topical and just couldn’t get the same results and are therefore now less enthused. It doesn’t match their business plan. Hopefully Shiseido can release the injection plan at some point.

    1. Where did you you get your information that Shiseido was trying to turn this into an everyday topical? I tend to agree with Stu. Their premise has been based on culturing cells and no group has figured that out yet, let alone an under-capitalized company like Replicel. I also recall some time ago where a researcher, who was involved in cell culturing, was posting on a site saying that while there had been some success with culturing dermal papillae cells (up to 60% inductivity), there was zero success in culturing dermal sheath cup cells, which is what Replicel is based on. Maybe this has changed, but if you look at Replicel’s stock it is at an all-time low of under 20 cents per share. So if they have had any behind the scenes success, they are very tight lipped about it.

  3. One important side note left out in this article is we know for sure shiseido started human trials over a year and a few months ago.

    That being said despite our shaky speculation we know for absolute certain that there are people deep in that company that know for sure whether it works or not right now .. Today.

    My only wonder is Why they havent gone public. If it worked wouldnt they already have organized preliminary treatment centers. It makes me doubt success.

    The only way it does work is if they are in the marketing process right now. But they said 2018 so….. If they stalled on that release they either scrapped it or tweaking the delivery for a higher outcome. Or it doesnt work at all.

  4. Incuded in Replicel’s agreement with Shiseido was a commitment to complete their own Phase 2 trials of RCH-01 in Germany.

    When Replicel failed to conduct these trials, Shiseido claimed the terms of their agreement had been broken – and as such Shiseido would no longer share either the results of their trials, or any future revenues, with Replicel.

    Replicel disputed this by saying the agreement didn’t stipulate “when” they would conduct the German trials, just that they would.

    This is why Replicel now essentially doesn’t know more than anyone else about where Shiseido is at.

    In the meantime…..Replicel has been involved in a joint research project with the University of British Columbia seeking to clarify what differences existed in the hair follicle gene expression of subjects who had a strong hair growth response in their earlier RCH-01 phase I/IIa clinical trials and the subjects who had a reduced hair growth response.
    (The recent Replicel shareholder update stated stage 1 of this research “has successfully completed (details to be announced shortly)”)

    Presumably if Replicel can isolate what particular gene / protein expressions yield better treatment responses for their treatment, this might bring Shiseido back to the table – as otherwise Shiseido would be limited to using only the earlier Replicel technology covered in their original agreement.

    So it will be interesting to see both the results from the University of British Columbia joint study and the Shiseido study when they are announced – and how this may all play out.

    1. This basically answers the question you posed in the following post. Investors see an argument with one of the largest companies in Japan and run a mile. Any reasonable analysis of the information publicly available shows Replicel are at fault for not holding up their end of the bargain. This is a poorly run company with a decent-ish product. Without Shisheido’s backing i have lost all hope for this product.

  5. They should just release whatever they have, even if it’s just maintenance. Too much bs with hair loss industry. Why does everything have to be so exhausting with this sh*t.

  6. They have every incentive to meet their 2022 target, otherwise they won’t be first in Japan. Riken comes to mind.
    I suspect this year will be make or break for Replicel’s RCH-01 depending upon the results.

  7. I live in Vancouver where the University of British Columbia is – there were no human trials at UBC , so I’m curious where all this talk is coming from ?
    They ( Replicel’) did do a trial a few years back on Achilles’ tendons and I actually tried to get in but didn’t qualify . At the time , I spoke with someone who was overseeing it and was at an arms length distance from Replicel . He was involved in making sure their trials were ethical and run propey .
    I questioned him and he was somewhat open about Replicels technology, to me he didn’t seeemed convinced it was sound for both hair and the Achilles .
    Put it this way – he had already seeem preliminary results and he was not all That excited . Ever since that conversation, I’ve never been convinced Replicells science is the answer,
    Im guessing , it does something, but for myself , it probably wont be a game changer .

    1. Hi Stu,

      I have no “inside information” – the reference for the UBC study came from a Replicel news release, June 13, 2017. (See link below)

      I believe the study intended to use pre-existing data from Replicle’s earlier trials rather than conducting new human trials.

      Was interesting to hear the views of your friend / associate who was somewhat involved in the Replicel tendon study!

      Cheers.

      https://replicel.com/news/replicel-collaborates-with-university-of-british-columbia-to-build-world-class-hair-follicle-cell-data-map

    1. Hey Bekoo, you’ve posted the link twice which makes it a broken link.

      https:/edgy.app/researchers-discover-new-hair-loss-prevention-technique

  8. Yep great work Xtra and all other comments -been waiting for this post admin ..:and will be eagerly waiting for more as I think this regent stuff is the cure!

    1. FYI, George is a speaker next month at the 11th world hair congress, maybe some news. Also Samumed is one of the main sponsors.

  9. I think the “If Shiseido decides to do so” comment was just them not wanting to speak for Shiseido.

    They have a history of playing it close to the vest and not overhyping, which I actually respect

    1. That Rapunzel site sounds promising. The same idea behind Tsuji is it not? Does Christiano have cultured hair cell science up to where it needs to be to start performing the so called “cure” of unlimited donor area hair transplants?

  10. Hi Admin,

    What’s your take on this HairClone (UK) Reddit AMA?

    https://www.reddit.com/r/tressless/comments/a65uew/hairclone_developing_cell_replacement_treatments/

    Although I highly appreciate their CEO taking the time to answer questions, I find it an absolute joke they have the audacity to tell people to crowdfund them with no proof of concept. Another thing is the involvement of a certain hair transplant doctor tells me this is nothing but a marketing exercise for his UK clinics.

  11. Hey guys has anybody used rogaine? What are your experiences with it? My hair just started thinning should I wait to use it? How is the dropper or foam? Which is better?

    1. I use the Regain foam and have found it has slowed my hairloss over the last 4 years. You have to be consistent with it. It’s not a miracle and i’m still losing ground but definitely at a slower pace.

    2. I used it for 9 year, but stopped giving benefits the last few years. My heartbeat increased to the point that I had to stop. At that point i had a massive horrible shedding and thing kept going downhill. My advice is don’t even start that crap.

  12. A couple weeks ago there was a really, really good article about Christiano: https://magazine.columbia.edu/article/radical-solutions-baldness

    Some Quotes:

    “She quickly learned why there was so little progress on hair disorders. ‘Institutions wrote back to me saying, in essence, that hair loss was trivial, cosmetic, insignificant in comparison to AIDS and cancer.”

    It had been fifteen long years since Christiano discovered the first gene for hair loss. […] “I’m happy to say that this year, for the first time, we’ve finally found some genes.” The room got quiet. Then people stood up. They began to weep, and, in a show of unity, they started taking off their head coverings. Christiano, unprepared for any of it, dissolved into tears.

    Christiano learned more about the feelings that surround hair loss. “Because the condition is usually progressive, once it starts, people really struggle,” she says. “I’ve heard people say: ‘I couldn’t get out of bed.’ ‘I will not take off my hat.’ ‘I won’t go out in the wind because I’m afraid my prosthetic will come off.’ ‘I won’t be intimate with someone.’ ‘I can’t go on this job interview.’ ‘I’m afraid to show my family.’

    “You need to walk a day in the shoes of someone before you cavalierly dismiss AA as ‘just cosmetic.’ It’s easy to trivialize it. But people are desperate, and vulnerable to the core. They’re up all night reading about hair and counting the hairs in the drain and looking in the mirror. You can’t understand it unless you’ve been there.”

    [of JAK Inhibitors for AA] The drugs are still in clinical trials and could gain FDA approval as soon as 2021.

    There has never been a truly successful treatment for the most common form of hair loss, androgenetic alopecia, better known as male pattern baldness.

    FROM ONE, MANY

    “Experiments are underway, and the evidence has been tantalizing. In theory, that little scallop of scalp floating in the dish at the Christiano Lab could be the source of a full head of hair. Working toward that future, Christiano and her team harvest the cultured follicles and implant them in artificial skin built in the lab. This skin nourishes the follicle, prodding from it a colorless, keratin-protein filament. The team then removes the productive follicle and grafts it onto the skin of a mouse. The result? Hair growing out of mice — human hair.

    Christiano expects to move these trials from mice to people in two to three years [2021-22], bringing nearer the day when people can grow, in a lab, their own viable hair follicles — a limitless supply of one’s own hair.

    “From one, many,” Christiano says. “That’s a beautiful technology.”

    [!!!]

    1. Don’t worry guys, the cure is only 5 years away.

      2024: Don’t worry guys, the cure is only 5 years away.

      2029: Don’t worry guys, the cure is only 5 years away.

  13. I seem to recall a posting from Replicel that Shiseido was waiting for Replicel’s dermal injector to hit the market first before proceeding with bringing the hair loss “cure” to marketplace. If that is still true, Replicel announced today that the injector will be released next year in China, Hong Kong and Europe.

  14. Results from Shiseido’s study of RCH-01 in Japan will be released within two months (as of posting) as per personal email from Dr. Tsuboi, who lead the research. No word on market launch or effectiveness however Shiseido recently redesigned the R&D section of their website and it includes the Cell Processing and Expansion Centre (SPEC) in Kobe front and centre on a map:

    https://www.shiseidogroup.com/rd/collaboration/

    In my opinion, if it was a dud, this would have been quietly removed. The fact it is there makes me optimistic.

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