Next-stage trials in Japan present market launch opportunities for
RepliCel's skin and tendon products
VANCOUVER, March 19, 2019 /CNW/ - RepliCel Life Sciences
Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the
"Company"), a company developing next-generation technologies in
aesthetics and orthopedics, is pleased to announce the
resumption of their First-in-Japan
strategy.
The Company, working with industry leaders, CJ PARTNERS, have
initiated a program in Japan to
realize its goal of launching its cell therapy products in
Japan sooner than would be
possible anywhere else in the world. Because of this unique
opportunity, the Company's next-phase trials will be conducted in
Japan.
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. The strategy to bring its products to market
first in Japan spans the Company's
entire portfolio. While the Company's RCH-01 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.
RepliCel is leveraging a history of working in Japan which began in 2013 when the Company
laid the foundation for its First-in-Japan strategy as one of the first foreign
regenerative medicine companies to have a Japanese partnership.
RepliCel followed that in 2015 as one of the first foreign
regenerative medicine companies to initiate a consultation process,
under the new regulations for regenerative medicine products, with
Japan's PMDA (Pharmaceuticals and
Medical Device Agency).
Again in 2016, RepliCel's licensee, Shiseido Company, was one of
the first companies to fund, and manufacture a product for use in,
a clinical study under the newly enacted Act for the Safety of
Regenerative Medicine (ASRM).
While 2017 and 2018 saw RepliCel focus activity in Europe, Canada, and China, only weeks after the Board recently
authorized a resumption of its First-in-Japan strategy, the Company has already
initiated:
- the continuation of its regulatory review process with the PMDA
for the Company's cell therapy platform;
- planning for a clinical trial of its RCT-01 product for the
treatment of tendinopathy;
- planning for the clinical trial of its RCS-01 product for skin
rejuvenation;
- preparations to submit the application to the PMDA for approval
to market the Company's dermal injector (RCI-02) upon it being
CE-marked.
"With the regulatory reform for regenerative medicines now
firmly entrenched," states Colin Lee
Novick of CJ PARTNERS, "there is an exciting maturity
impacting the evolution of the cell therapy industry in
Japan as never seen before. We are
seeing another wave of foreign-domestic partnership, an emerging
trend of foreign companies sponsoring their own clinical
development in Japan, and a
dramatic increase of domestic-sponsored clinical activity. This is
beginning to materially impact patients, health care providers,
investors, biopharma companies, and ancillary industries in ways
which were only imagined in 2013 when the reforms were first
drafted. It is an exciting time for both foreign and domestic
stakeholders who decide to invest in Japan's rapidly developing regenerative
medicine sector."
RepliCel's First-in-Japan Strategy: A Portfolio View
RCT-01 for chronic tendinopathy - A Japanese clinical trial of
RepliCel's RCT-01 treatment for tendinopathy is aimed at obtaining
conditional approval from Japan's
regulatory authority to market the product and obtain medical
insurance reimbursement there for up to seven years before an
application for final approval is required.
RCS-01 - A clinical study of the Company's RCS-01 treatment for
the rejuvenation of aging and sun-damaged skin is expected to lead
to a launch of the product in Japan under the nation's Act for the Safety of
Regenerative Medicine.
RCI-02 - RepliCel's next-generation, dermal injector, a medical
device designed to deliver optimized and controlled injection of
cell therapies and other injectables, is expected to be launched in
Europe, Hong Kong and other markets accepting CE mark
approval next year. The marketing approval application for the
injector will be submitted in Japan as soon as possible once the CE mark
application is submitted. The device will be marketed for the
injection of various dermatology treatments but is expected to be
critical to delivery of the Company's RCS-01 treatment.
RCH-01 – A Japanese clinical study of RepliCel's RCH-01
treatment for hair loss due to androgenic alopecia, approved by
Japan's Ministry of Health, Labour
and Welfare, has been the subject of a clinical study recently
completed at Tokyo Medical University Hospital and Toho University
Medical Center Ohashi Hospital. The market is now keenly watching
Shiseido Company, RepliCel's licensee of the product for
Asia, for any signal regarding its
launch of that product in Japan.
Resources About Cell Therapy in Japan
Video: "Invest in Japan:
Medical Industry" - https://youtu.be/lVym_W0ADYo
Video: "Has Japan's Regenerative Medicine Experiment Paid
Off?" - https://youtu.be/eT8hjjzyuzI
Article: "Regenerative Medicine Environment ‐A Guide to
Understand the Pathways to Get Approval in Japan" -
https://firm.or.jp/_rmit/wp-content/uploads/2018/10/Japans-RM-Environment-2018.pdf
Article: "Japan's regulatory
gamble and what it means for the Industry" -
http://www.cj-partners.com/en/news/files/000025_en_01.pdf
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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SOURCE RepliCel Life Sciences Inc.