Received this update today, from Replicel:
RCH-01
Arbitration with Shiseido – On October 18, 2021 RepliCel filed an arbitration claim seeking Shiseido’s return of the license and all collaboration data and innovations related to its cell therapy treatment for male and female pattern hair loss. On December 21, 2021 the Company announced it had legally terminated the Agreement with Shiseido. RepliCel and Shiseido have submitted their Statement of Claim and Statement of Defense, respectively. A round of procedural orders in November culminated in a Hearing date having been set for May 29, 2023; a ruling from the tribunal is expected by or before Q4 2023. The company continues to be represented by top international law firm, Aceris Law, and outstanding legal advisors. “With an excellent legal team, a positive resolution to the ongoing proceedings with Shiseido remain a top priority for the company,” Schutte stated.
RCH-01 in Japan – With our understanding of the ASRM regulations in Japan, coupled with the clinical results to date, we believe the product has the necessary clinical and safety profile to pass regulatory clearance. We are preparing for all eventualities in Japan.
RCH-01 Offshore Strategy– RepliCel is progressing the commercialization of RCH-01 and intends to partner with clinics in regions adjacent to the United States. “We believe RCH-01 represents the first major step forward in the treatment for hair loss in nearly a quarter of a century,” Schutte stated. RepliCel has a strong commitment to upholding clinical and manufacturing standards, and fully intends to have third party validation. As agreements materialize, we will update the market accordingly.
RCH-01 in Europe and the United States – RepliCel remains committed to launching RCH-01 in the United States and Europe. Once the ongoing litigation with Shiseido is resolved, RepliCel intends to begin developing the infrastructure to launch next phase clinical trials in the U.S and/or Europe as finances, synergies, and regulatory frameworks permit. “The company remains committed to launching next phase clinical trials in the U.S and Europe at the earliest opportune time,” Schutte stated. “We are eager to incorporate research and development findings into our next phase clinical trials.”