Tweet
RepliCel Reports Progress on Shiseido Technology
RepliCel Reports Progress on Shiseido Technology Transfer for RCH-01 Treatment for Pattern Baldness
Vancouver, Canada - December 19, 2013 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (CNSX: RP) today reported on the progress of its technology transfer agreement with its partner, Shiseido Company, Limited.
Recently, a group from Shiseido met with RepliCel management and advisors in Vancouver, BC to continue the technology transfer between the two companies as outlined in the July 9, 2013 licensing agreement. The Shiseido team spent three weeks in the lab with RepliCel's Chief Scientific Officer, Dr. Kevin McElwee and Director, Research and Development, Dr. Hisae Nakamura learning techniques of specific hair follicle cell isolation and replication methods for RCH-01. Furthermore, RepliCel's Vice-President of Clinical Affairs, Darrell Panich reviewed progress to date in the clinical development program of RCH-01 and discussed the plans for future development in the companies' respective regions.
During this past quarter, Dr. Nakamura and representatives from the Shiseido team visited RepliCel's contract Good Manufacturing Practice compliant facility in Innsbruck, Austria. It was during this visit that the transfer of RCH-01 manufacturing technology between the two companies and its contract manufacturer was initiated.
"These meetings have done much to foster the collaborative relationship between RepliCel and Shiseido and both companies are committed to working very closely on the successful development of RCH-01," said Chief Scientific Officer, Dr. Kevin McElwee. "Both teams will continue in-depth research and development in the laboratory and clinical trials with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair." In this regard, RepliCel expects to initiate a Phase 2 clinical trial for RCH-01 in the EU in the first half of 2014. In addition, both companies will work towards establishing a clinical research program in Asia with the goal of increasing the available human clinical data on RCH-01. Collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party.
As per the agreement, Shiseido will have an exclusive geographic license to use RepliCel's RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.
New Regenerative Medicine Legislation Passed in Japan
On November 20, 2013 the Japanese Legislature approved new legislation targeted at improving the development and regulatory processes for regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare to adopt new procedures and rules that will accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law will now become the Pharmaceuticals and Medical Devices Act that will include a new branch specifically for Regenerative Medicine Products, which will be regulated on a fast track process that focuses primarily on product safety. Under the law, the government is responsible for mapping out and implementing measures to safely accelerate research and development projects and make regenerative medicine widely available in the country. The law specifically stipulates that the government must make basic plans for the promotion of regenerative medicine and change such plans if necessary by reviewing them at least every three years in light of any changes in external conditions that may occur. This news positively impacts RepliCel and its licensing partner, Shiseido, as it looks to conduct human clinical trials on RCH-01.
Vancouver, Canada - December 19, 2013 - RepliCel Life Sciences Inc. (OTCQB: REPCF) (CNSX: RP) today reported on the progress of its technology transfer agreement with its partner, Shiseido Company, Limited.
Recently, a group from Shiseido met with RepliCel management and advisors in Vancouver, BC to continue the technology transfer between the two companies as outlined in the July 9, 2013 licensing agreement. The Shiseido team spent three weeks in the lab with RepliCel's Chief Scientific Officer, Dr. Kevin McElwee and Director, Research and Development, Dr. Hisae Nakamura learning techniques of specific hair follicle cell isolation and replication methods for RCH-01. Furthermore, RepliCel's Vice-President of Clinical Affairs, Darrell Panich reviewed progress to date in the clinical development program of RCH-01 and discussed the plans for future development in the companies' respective regions.
During this past quarter, Dr. Nakamura and representatives from the Shiseido team visited RepliCel's contract Good Manufacturing Practice compliant facility in Innsbruck, Austria. It was during this visit that the transfer of RCH-01 manufacturing technology between the two companies and its contract manufacturer was initiated.
"These meetings have done much to foster the collaborative relationship between RepliCel and Shiseido and both companies are committed to working very closely on the successful development of RCH-01," said Chief Scientific Officer, Dr. Kevin McElwee. "Both teams will continue in-depth research and development in the laboratory and clinical trials with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair." In this regard, RepliCel expects to initiate a Phase 2 clinical trial for RCH-01 in the EU in the first half of 2014. In addition, both companies will work towards establishing a clinical research program in Asia with the goal of increasing the available human clinical data on RCH-01. Collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party.
As per the agreement, Shiseido will have an exclusive geographic license to use RepliCel's RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people.
New Regenerative Medicine Legislation Passed in Japan
On November 20, 2013 the Japanese Legislature approved new legislation targeted at improving the development and regulatory processes for regenerative medicine therapies. The Regenerative Medicine Law directs the Ministry of Health, Labour and Welfare to adopt new procedures and rules that will accelerate the clinical development of regenerative medicine and cell therapies. The Japanese Pharmaceutical Affairs Law will now become the Pharmaceuticals and Medical Devices Act that will include a new branch specifically for Regenerative Medicine Products, which will be regulated on a fast track process that focuses primarily on product safety. Under the law, the government is responsible for mapping out and implementing measures to safely accelerate research and development projects and make regenerative medicine widely available in the country. The law specifically stipulates that the government must make basic plans for the promotion of regenerative medicine and change such plans if necessary by reviewing them at least every three years in light of any changes in external conditions that may occur. This news positively impacts RepliCel and its licensing partner, Shiseido, as it looks to conduct human clinical trials on RCH-01.
Comment