New update from Replicel,
Press Release
Hair Re-growth RCH-01 – Shiseido is currently funding a second clinical study of RCH-01 (they call it S-DSC) in Japan testing the impact of a series of injections on areas of thinning hair due to androgenetic alopecia. It is expected that this study, if successful, will be the basis for a commercial launch of the product by Shiseido in Japan.
Once the RCI-02 injectors and consumables are available for clinical studies, RepliCel will begin preparations for a phase 2 human clinical trial of RCH-01 outside of Asia (Shiseido’s licensed territory) examining both dose and injection frequency for the treatment of hair loss.
RepliCel Dermal Injector (RCI-02) Product Line – Manufacturing of RepliCel’s initial batch of commercial-grade dermal injectors and related consumables is now resuming. Upon delivery of the first units, we will commence the functional testing needed that will produce the data required to form the basis of the marketing approval application that will be submitted on our behalf by the regulatory team at MainPointe Pharmaceuticals, our US partner and distributor.
Over the next few weeks as we, our contract providers in Europe, and our collaborators at MainPointe Pharmaceuticals, gain more clarity regarding the requirements and updated timing of resumed production, product testing/validation, and regulatory submissions, we will provide more detail on the anticipated timing of a regulatory approval application and market launches in the United States and Hong Kong this year.
Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not yet the subject of any litigation or arbitration. RepliCel maintains the agreement remains intact and is communicating with Shiseido its expectation that (a) they deliver to RepliCel the full clinical data set from the recently completed study of RCH-01 in Japan and (b) confirm that their license agreement remains intact without breach. RepliCel reserves the right to take the position that Shiseido’s failure to deliver the clinical data from the recently completed clinical study in Shiseido’s Territory constitutes a material breach of contract. Based on legal advice, management believes that now is the right time to proactively bring the disagreement to a resolution and will proceed accordingly.