If Shiseido Decides to Do So
Update: November 26 2019 — Replicel released its 2019 year-end update today. Regarding the company’s cellular therapy (RCH-01) for androgenetic alopecia, the key points are that:
- Shiseido’s clinical study in Japan is now complete.
- Shiseido will soon announce on whether it will commercially launch the product in Japan or conduct further clinical testing.
- Replicel is holding off on Shiseido’s final decision before pursuing any further Phase 2 trials.
- The Replicel and Shiseido dispute is still unresolved.
It seems like Shiseido could still launch the product in Japan soon. No doubt aided by the country’s new faster regulations for marketing when it comes to cellular therapy.
March 23, 2019
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 in the near future.
Besides 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:
- Shiseido could release the product well before 2022. See my past post on Shiseido’s new research facility in Kobe, Japan.
- 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.
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