Japan's Regulatory Agency, PMDA, Clears RepliCel Life Sciences to Proceed to Final Consultation for Tendon and Skin Cell Therapy Products
RepliCel completes the second of three formal consultation reviews with Japan's Pharmaceuticals and Medical Devices Agency in its application to obtain clearance to proceed with two clinical studies
VANCOUVER, BC – 11 March 2020 – RepliCel Life Sciences Inc (OTCQB: REPCF) (TSX.V: RP) (Frankfurt: P6P1), a clinical-stage regenerative medicine company developing cell therapy products in aesthetics and orthopedics, announced that it met recently with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo.
The meeting was a formal consultation review of the company's pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology underlying the Company’s tendon regeneration and skin rejuvenation programs and follows-up on a previously conducted consultation. This review was the second of a required three-step process to obtain PMDA consent to perform clinical trials in Japan.
As previously announced, RepliCel has prioritized and is actively engaged in Japan with the clinical development and commercialization of its tendon regeneration and skin rejuvenation regenerative medicine cell therapy products as well as its near-commercial dermal injection technology.
“Obtaining the PMDA’s clearance to proceed to the final consultation required to obtain their clearance for clinical studies is precisely where we wanted to be at this stage,” stated RepliCel CEO & President, R. Lee Buckler. “This provides a clear signal to Japanese investors, clinicians, and strategic partners with whom we are in discussions, that we are delivering on our ‘First-in-Japan’ strategy which aims to have four products on the market in Japan by 2023.”
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.
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This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: that the Company will launch its dermal injector (RCI-02) and related consumables; that the Company will launch clinical development of its NBDS products in Japan; that the Company will obtain approval to launch the next-phase clinical trials of its tendon product (RCI-01) and skin product (RCS-01) in Japan; that the Company will enter into partnership agreements in Japan for its RCI-01 device and NBDS cell therapy products; that the Company will launch its next-phase clinical trials of RCS-01 in Japan as soon as the RCI-02 device and consumables are available in Japan; These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain regulatory marketing approval for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2018 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.
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