RepliCel News - Shiseido & RepliCel Announce Agreement

[lurker77]

FOR IMMEDIATE RELEASE



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



Tokyo, Japan and Vancouver, Canada - May 29, 2013 - 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. In addition, Shiseido will pay RepliCel sales milestones up to ¥3,000,000,000. 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

https://www.replicel.com

Shiseido Company, Limited

Public Relations Department

Tatsuyoshi Endo

Tel: +81-3-6218-5200

tatsuyoshi.endo@to.shiseido.co.jp

https://www.shiseido.com

[Henkeh91]

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

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.

[lurker77]

While we don't yet know HOW effective this product is, this shows that the product IS effective at treating MPB.

This represents VERY good news, as it is the first "cutting edge" treatment available to market Hopefully it will be worth the trip to Asia, but exciting stuff nonetheless!

[Henkeh91]

While we don't yet know HOW effective this product is, this shows that the product IS effective at treating MPB.

This represents VERY good news, as it is the first "cutting edge" treatment available to market Hopefully it will be worth the trip to Asia, but exciting stuff nonetheless!

Agreed! It looks really promising at this moment for sure!

[FearTheLoss]

Yes, they are on track for their 2015 release in Asia!!

[hellouser]

How awesome will it be to go on vacation to Asia, see a new world and culture and at the same time get a simple procedure done with Replicel to restore hair?! Oh man, SO FVCKING EXCITED!

[KO1]

Where did you get the 2015 number from? Dammit why aren't more firms investing in this?

I wish I headed a giant pharma. This area is so undercapitalized, has so much demand, and hair loss is GLOBAL, there is no need for FDA approval. Ridiculous.

[hellouser]

Where did you get the 2015 number from? Dammit why aren't more firms investing in this?

I wish I headed a giant pharma. This area is so undercapitalized, has so much demand, and hair loss is GLOBAL, there is no need for FDA approval. Ridiculous.

Youre forgetting that the procedure would have an endless supply of patients. Its not like a vaccine or halt against future balding men.... not unless men go extinct (I don't care about women in this reference, theyre insignificant and get way more special treatment in other areas... just look at the sad inequality between breast cancer and prostate cancer funding and awareness campaigns).

[KO1]

I guess you read Spearhead. There is no question about the disparity in attention for healthcare. Watching NFL athletes wear pink ribbons for breast cancer.....eh. But yes, permanent supply of bald men every year. But most importantly IMO, there is just no reason to dance in front of the FDA to get approval. Demand is everywhere. IF the science is good, they need to release it somewhere with lower legal hurdles.

[hellouser]

I guess you read Spearhead. There is no question about the disparity in attention for healthcare. Watching NFL athletes wear pink ribbons for breast cancer.....eh. But yes, permanent supply of bald men every year. But most importantly IMO, there is just no reason to dance in front of the FDA to get approval. Demand is everywhere. IF the science is good, they need to release it somewhere with lower legal hurdles.

I'm going to reach out to Tammey once more and ask about which countries in Asia will be host to Replicel's treatment. Gonna make some grand plans for the future. Cant wait.

[lurker77]

I'm going to reach out to Tammey once more and ask about which countries in Asia will be host to Replicel's treatment. Gonna make some grand plans for the future. Cant wait.

Japan, China, South Korea, Taiwan and the ASEAN countries are named specifically in the release.

[yagazooci]

This is great news that Shiseido has officially bought into the replicel idea. What it boils down to at this point is that they have at least the same level of confidence that the company has in its potential and their money is now where their mouth is, so to speak. So with German trials happening a little later this year and what looks to be a further trial in Japan in the offing, I'd say they will crack this wide open. Japan, it says, is morphing it policies to improve approval wait times. Heaps of positives here. My how this company bounces back; a sign of tenacity and what is very likely a crew with the right stuff. Shiseido is a confidence builder for a crew of apparently already confident people. Going to be interesting.

[FearTheLoss]

Where did you get the 2015 number from? Dammit why aren't more firms investing in this?

I wish I headed a giant pharma. This area is so undercapitalized, has so much demand, and hair loss is GLOBAL, there is no need for FDA approval. Ridiculous.

Look at the bottom of this page...

http://www.replicel.com/hair-regeneration/cause-of-hair-loss/faqs/

When will your Phase II trial commence?
We anticipate initiation of our Phase II dose-ranging trial in late-2013.

"Do you have a rough estimate of how long it will take for the treatment to be available to the public?

RepliCel is following a clear regulatory clinical pathway. Upon completing the first-in-man Phase I clinical trial, which is designed to test safety as well as efficacy, the company will initiate a Phase II dosing trial followed by a Phase III approval trial. The timeline to a commercial product depends on the execution of these trials and regulatory approvals. Nevertheless, if the technology proves safe and effective, RepliCel anticipates that a commercial product may be available in 2015 in non-Western jurisdictions."

EVERYTHING IS ON TRACK!!

[TravisB]

Wow, that Shiseido company sounds like they are pretty convinced that Replicel works, no?

I wonder how does it work, when their last (Phase 2A I believe) results were very mediocre in terms of regrowth?

Maybe it at least stops MPB for good?

If such large (4th cosmetic company in the world) company have faith in Replicel then surely it must be effective?

[FearTheLoss]

Wow, that Shiseido company sounds like they are pretty convinced that Replicel works, no?

I wonder how does it work, when their last (Phase 2A I believe) results were very mediocre in terms of regrowth?

Maybe it at least stops MPB for good?

Again, all we can do is speculate..but we know one thing is for sure, for a company like Shiseido do invest the amount of money they did in RepliCel, they have to have something that has shown to be far better than propecia or minox...

not to mention RepliCel is still on track for a 2015 release!!