RepliCel Reports Progress on Shiseido Technology Transfer for RCH-01 Treatment for Pattern Baldness
VANCOUVER, BC – 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.
About RepliCel Life Sciences
RepliCel is a clinical stage biopharmaceutical company focused on developing autologous cell therapies. RepliCel Tendon-01 (RCT-01) is a cell therapy for the treatment of chronic tendon injuries. RepliCel Hair-01 (RCH-01) is a cellular treatment for androgenetic alopecia (pattern baldness). Shiseido Company, Limited has an exclusive geographic license for RCH-01 in certain Asian countries including Japan, China and South Korea. Both product candidates are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. For additional information please visit www.replicel.com.
About Shiseido Company, Limited
Shiseido was established in 1872 as Japan’s first Western-style pharmacy. Since then, the company has led the cosmetic technology and culture in Japan over more than 100 years. The company now aspires to become a “global player to represent Asia with origins in Japan” and operate businesses all over the world, including Europe, the U.S. and Asia. Its representative global brand, “SHISEIDO” is now sold in 89 countries and regions as of April 2013.
Tammey George, Director of Communications
RepliCel Life Sciences<
Westwicke Partners, LLC
Stefan Loren, Ph.D., Managing Director
Robert H. Uhl, Managing Director
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include the following: (i) that the Company will conduct further human clinical trials; (ii) that ongoing research collaboration will be conducted by the Company and Shiseido for the continued improvement of the technology; (iii) that a commercial, safe and effective hair regenerative treatment will be developed and commercialized; (iv) that the Company and Shiseido will develop further improvements to the technology; (v) that the Company will undertake and enter into development and collaboration agreements for the development of its technologies; and (vi) and that the Company’s technology will rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers. 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 information, including: that negative results from the Company’s clinical trials may impact further clinical trials, development, approval and commercialization of the technology; the effects of government regulation on the Company’s business, including the future development of the technology; 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; that the Company may not be able to find other parties will to participate in the development and collaboration of its technologies, 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, 2012 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.
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