Friday, July 12, 2013

Replicel and Shiseido Complete Collaboration and Technology Transfer Agreement on Technology for Treating Pattern Baldness

Replicel and Shiseido Complete Collaboration and Technology Transfer Agreement on Technology for Treating Pattern Baldness


July 11, 2013
Source: replicel.com

Vancouver, Canada – July 11, 2013 – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) (CNSX:RP) is pleased to report that it has completed the previously announced Collaboration and Technology Development Transfer Agreement (the “Agreement”) with Shiseido Company, Limited (“Shiseido”). A joint steering committee will now be formed to oversee the transfer of the technology, knowhow and standard operating procedures. As defined by the Agreement, Shiseido will pay RepliCel an upfront fee of ¥400,000,000 (approx. CDN $4,200,000). In addition, Shiseido will pay RepliCel sales milestones amounts of up to ¥3,000,000,000 (approx. CDN $31,500,000) and royalties.
The Agreement gives Shiseido 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. Shiseido and RepliCel will collaborate on the continued improvement of the technology and will conduct human clinical trials in each of their territories with the goal of commercializing a safe and effective hair regenerative treatment to help those suffering from pattern baldness and thinning hair.
David Hall, CEO of RepliCel commented, “This agreement gives RepliCel’s RCH-01 hair regeneration technology important third-party validation from one of the most respected cosmetic companies in the world. In addition, the Japanese government has recently committed to establish a new approval process for regenerative medicine products focused on accelerating approval timelines. This changing regulatory environment enhances the strategic nature of our collaboration with Shiseido. In parallel with RepliCel’s planned Phase II trial in Europe, the Shiseido license represents a second clinical pathway for the development of our RCH-01 technology.”
“We look forward to working with Shiseido with its deep expertise in hair research. We anticipate that our collaborative efforts will support the continued improvement of our technology,” stated Dr. Rolf Hoffmann, Chief Medical Officer of RepliCel. “This license represents the first of many development and collaboration agreements we intend to undertake around our broader platform of addressing cellular deficits in diseases such as pattern baldness and tendinosis,” concluded Dr. Hoffmann.
Asia’s Hair Loss Market
With the increasing awareness of baldness as a medical condition that can be treated; the demand for hair loss treatments has sharply risen; especially in the Asian market. For example, a study by the Peking University People’s Hospital published in the British Journal of Dermatology in 2010 found that 21 percent of adult males and six percent of females in China suffer from hormone-driven hair loss. Furthermore, the International Society of Hair Restoration Surgery’s (ISHRS) biennial survey of hair restoration physicians found that the number of hair restoration patients in Asia grew 345% from 2004 to 2010. Shiseido has also conducted research on hair and scalp concerns. Their survey of women living in Tokyo, Shanghai, Chengdu and Bangkok found that women aged 40+ commented that their hair was thinning.
RCH-01 Procedure
RCH-01 is a patented cellular replication and implantation technology designed to rejuvenate damaged and miniaturized hair follicles in balding scalp. This technology has been developed over ten years of research, experimentation and clinical trials. The mechanics of this technology involve the extraction of as few as 20 hair follicles from the back of a patient’s scalp where healthy cycling hair follicles reside. Specific cells are isolated from hair follicles and are cultured in a current Good Manufacturing Practice compliant facility using the Company’s proprietary cellular replication process. The cultured cells are reintroduced back into balding areas on a patient’s scalp and are expected to rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers.
About RepliCel Life Sciences
The Company is developing two autologous cell therapies; the first being a cellular treatment for androgenetic alopecia (pattern baldness); RCH-01; and the other being a cell therapy for the treatment of chronic tendon injuries (RCT-01). Both products are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. Each program is in the regulatory process of preparing for Phase II clinical trials. RepliCel’s business model is to develop and license its technologies to fully integrated life science companies.

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.

For more information please contact:

RepliCel Life Sciences Inc.
Tammey George, Director of Communications
Tel: 604-248-8696
tg@replicel.com
www.replicel.com

RepliCel and Shiseido Announce Collaboration and Technology Transfer Framework Agreement and Exclusive Geographic Technology License

RepliCel and Shiseido Announce Collaboration and Technology Transfer Framework Agreement and Exclusive Geographic Technology License


May 29, 2013
Source: replicel.com

Tokyo, Japan and Vancouver, Canada – RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) (CNSX:RP) and Shiseido Company, Limited (“Shiseido”) (Tokyo Stock Exchange Code: 4911) (ADR Receipts: SSDOY) announced today that they have entered into a Collaboration and Technology Development Transfer Framework Agreement (“the Agreement”) for an exclusive geographic license for RepliCel’s RCH-01 hair regeneration technology. Under the final agreement, Shiseido will pay RepliCel an upfront fee of ¥400,000,000 (Approx. USD $4 Million). In addition, Shiseido will pay RepliCel sales milestones up to ¥3,000,000,000 (Approx. USD $30 Million). Replicel is also entitled to royalties on sales.
David Hall, CEO and President of RepliCel states, “Shiseido is one of the oldest and most respected cosmetics companies in the world with annual sales in excess of US$6.7 billion. Since its inception in 1872, they have stood at the forefront of science, innovation and beauty. They are known throughout the industry for their research and development in skin and hair biology as well as expertise in formulation and manufacturing. This Agreement for our RCH-01 autologous cell therapy for pattern baldness is consistent with our goal to partner with the leading companies in the field of hair regeneration. The Agreement also represents a key validation of our technology platform being built around the concept of addressing cellular deficits in human conditions.”
“Shiseido’s corporate mission is a research driven focus on human beauty and wellness,” stated Mr. Youchi Shimatani, Shiseido’s corporate officer in charge of research and development. “Our hair cell related research is to support those people suffering with pattern baldness. With this focus, I am delighted to be entering into a technical partnership with RepliCel which is a leader in hair regenerative technology,” concluded Mr. Shimatani.
Professor Rolf Hoffmann, RepliCel’s Chief Medical Officer commented, “The Agreement will ultimately see further human clinical trials being conducted by Shiseido in its territory. In addition, the Agreement anticipates ongoing research collaboration for the continued improvement of the technology. As Shiseido has world-class technical expertise in hair biology, we anticipate that together we will develop further improvements to the technology. As a co-founder of the Company, I am extremely pleased to be partnering with a leader in hair science.”
RCH-01 is a patented hair follicle cell replication and implantation technology designed to rejuvenate damaged, miniaturized hair follicles in balding scalp skin. This technology has been developed over ten years of research, experimentation and trials. The mechanics of this technology involve the extraction of as few as 20 hair follicles from the back of a patient’s scalp where healthy cycling hair follicles reside. Specific cells are isolated from the hair follicles and are then replicated in a current Good Manufacturing Practice compliant facility through the Company’s proprietary cellular replication process, and are then reintroduced back into balding areas on a patient’s scalp. The implanted cells are expected to rejuvenate damaged hair follicles leading to the growth of new healthy hair fibers.
“The Shiseido agreement represents another significant step in the development of RCH-01”, stated Dr. Kevin McElwee, Chief Scientific Officer. “We are excited to be collaborating with such a skilled group of scientists.”
The Agreement encompasses a geographic area including Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 Billion people. Joint steering committees will be established to oversee the transfer of the technology, knowhow and standard operating procedures.
About RepliCel Life Sciences
The Company is developing two autologous cell therapies. The first is a cellular treatment for androgenetic alopecia (pattern baldness) named RepliCel Hair-01 (RCH-01). The second is a cell therapy for the treatment of chronic tendon injuries named RepliCel Tendon-01 (RCT-01). Both treatments are based on RepliCel’s innovative technology which utilizes cells isolated from a patient’s own healthy hair follicles to address specific cellular deficits. Phase II clinical trials, for both technologies, are planned for the later part of 2013.
About Shiseido Company, Limited
Shiseido started business in Ginza, Tokyo in 1872 as the first Western-style pharmacy in Japan. 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.
For more information please contact:
RepliCel Life Sciences Inc.
Tammey George, Director of Communications
Tel: 604-248-8696
tg@replicel.com
www.replicel.com
Shiseido Company, Limited
Public Relations Department
Tatsuyoshi Endo
Tel: +81-3-6218-5200
tatsuyoshi.endo@to.shiseido.co.jp
www.shiseido.com

Tuesday, July 9, 2013

Heads up for the bald; a treatment may be near

Heads up for the bald; a treatment may be near


Author: Gemma Haines
Date: Sun, Mar 27 2011
Source: reuters.com
 

More than half of all men and four in ten women will suffer from some form of hair loss during their lives. While there are countless treatments that preserve hair, there are none that actually re-grow it.
 
But for those battling baldness - help may be on the way. Researchers at the University of California say they accidentally stumbled upon a powerful hair-growing compound, while examining stress in mice.

Dr Million Mulugeta says he and his team were studying how stress affects gastrointestinal function using mice that had been genetically modified to over-produce a stress hormone called corticotrophin-releasing factor, or CRF. The altered mice lost the hair on their backs, as if they were going bald. But as the researchers monitored the animals' treatment, they made a surprising discovery.
 
Dr Million Mulugeta, UCLA, saying "We noticed that some of these mice that were injected with a blocker of the stress hormone receptor, three months later they had fully re-grown their hair. That was a total surprise for us, we were not prepared."
 
The stress hormone blocker, known as astressin-B, had strong and long-lasting effects. The hair re-growth among the bald mice was so effective, they could no longer be distinguished from the others.
 
Dr Million Mulugeta, UCLA, saying "The antagonist we injected is very small, it is in micrograms it is in millionths of a gram, a single injection per day and five injections, that was enough to reverse hair loss."
 
The question now is whether astressin-B would have the same results on humans. 
 
Dr Million Mulugeta, UCLA, saying "Whether it works in humans or not is something we are very much interested in and something that we want to follow through. For now we don't know but some evidence that gives us hope that it may work, if not for several forms of hair loss at least for the subset of populations that suffer from stress-related hair loss."

It's enough, says Dr Mulugeta, to justify further research. He says that while an effective treatment for baldness may be many years away, his lab mice, have opened a new door for discovery.