Japanese Pharmaceutical & Medical Devices Agency
As part of its Japanese partnering strategy, RepliCel seeks advice of Japanese regulators around its fibroblast platform
RepliCel Life Sciences Inc. (TSX.V: RP) (OTCQB: REPCF), announced that it completed a meeting today with the Japanese PMDA (Pharmaceutical and Medical Devices Agency) as part of its plan to license one or more of its products in clinical development to Japanese strategic partners in the near-term.
RepliCel is developing two distinct autologous cell therapy platforms. The first is based on the company’s non-bulbar dermal sheath (NBDS) fibroblast platform and currently includes treatments for chronic tendinosis and UV-damaged and aging skin. The second is the company’s dermal sheath cup (DSC) cell platform for the treatment of pattern baldness (androgenetic alopecia) which is exclusively licensed to Shiseido Company, Limited for certain Asian countries including Japan, China and South Korea.
RepliCel’s proprietary (NBDS) fibroblast technology is a platform the company believes capable of generating multiple products to treat a variety of conditions, particularly where there is a deficit of cells capable of supporting sufficient levels of Type 1 collagen to maintain ideal function or aesthetic vitality. The company has developed its first two such products — treatments for chronic tendinosis and skin aging, both of which will be the subject of clinical trials in 2015.
It is these orthopedic and dermatological products based on RepliCel’s NBDS platform which are the subject of active discussions with potential Japanese investors and strategic partners. To support these discussions, RepliCel met with the Japanese PMDA to seek their input on the requirements for commercializing products from this platform in Japan.
“RepliCel is now quickly moving forward with licensing and partnership discussions with Japanese partners around our clinical programs for orthopedic and dermatological applications,” stated Lee Buckler, RepliCel’s Vice President of Business and Corporate Development. “Given the opportunity for early market access presented by the newly implemented regulatory reforms, we are focused on executing licensing and development deals with Japanese strategic partners. Seeking the advice of the PMDA facilitates these negotiations, and fostering a relationship with the Agency is an important part of ensuring we contribute to the building of a regenerative medicine industry in Japan that is bringing cell therapies to the Japanese people.”
“Our company is proud of our partnership with Shiseido,” stated RepliCel CEO, David Hall, “The Japanese market represents an important opportunity for RepliCel. Focusing on progress in Japan has become central to our current strategic plan to optimize value for our shareholders. We are impressed that the Japanese policy reforms have already generated measurable enthusiasm among both Japanese investors and therapeutic companies for being part of bringing foreign cell therapy technologies, like RepliCel’s, to Japan.”