Regenerative Medicine in Japan

Transcription

1 Cell & Gene Therapy World 2017 Regenerative Medicine in Japan January 19, 2017

2 Table of Contents Section Title Page # Japanese Regenerative Medicine Market Participants 3 Regenerative Medicine R&D in Japan 4 Japanese Regenerative Medicine Deals 5

3 Japanese Regenerative Medicine Market Participants Japanese Industry is getting behind the government s push to forward regenerative medicine and cellular therapies in Japan. Pharmaceutical companies in particular are increasingly expressing interest in the field. For non-japanese firms looking for a way into the market, such firms are convenient spring boards with their regulatory knowhow and experience. Regenerative Medicine & Cellular Therapy Market Players in Japan CMO/CPC CRO I CROS SMO Pharmaceutical Company Distribution Company Other 3 Reference: Company websites, various news articles and many aaaaa many more

4 Regenerative Medicine R&D in Japan In a testament to Japan s seeming greater focus on cellular-based technologies, there are many more early stage R&D products for Cell Therapies than there are Gene Therapies in Japan. However, both types of therapies are considered to be regenerative medicine products within the PMD. Act. Japanese R&D Status of Regenerative Medicines *1 Therapeutic Categories [n=75] Stage Cell Therapies Gene Therapies Companies *2 Research Project Pre-Clinical Regience (1), Cardio (1), SanBio (1), National Cerebral and Cardiovascular Center (1), SBI Holdings (1), etc. Healios (2), Regience (3), RepliCel (2), Regeneus (1), DiscGenics (1), Pluristem (1), SanBio (5), CellSeed (4), etc. 6.7% 6.7% 5.3% 9.3% 28.0% Phase I 3 4 Healios (1) National Cerebral and Cardio Center (1), Takara Bio (2), MolMed (1), etc. 12.0% 20.0% Phase II Phase III SanBio (1), Caladrius (1), Novartis (2), AnGes MG (1), ID Pharma (1), Takara Bio (2), Spark (1), etc. CellSeed (1), Mitsubishi Tanabe/AnGes MG/Sosei/Osaka University (1), etc. 12.0% Cancer Musculoskeletal Neurology Hepatic & Biliary Cardiovascular Sensory Organ Skin Other Approved/ Marketed 4 0 JCR Pharma/Mesoblast (1), Terumo (1), J-TEC (2) red font = cell therapies orange font = gene therapies The Cancer, Cardiovascular, Musculoskeletal and Sensory Organ categories combine to account for 72% of the regenerative medicine products currently being developed in Japan. A significant portion of the Cancer category are gene therapy candidates. 4 Reference: EvaluatePharma, Company websites *1: Japan has numerous other projects that are being developed at Universities and are not captured above *2: Some companies are further along with their development in other jurisdictions

5 Japanese Regenerative Medicine Deals Numerous licensing deals, CMO tie-ups and M&A deals involving Japanese pharmaceutical companies have taken place over the last few years with at least 10 such deals taking place in 2016 alone. Major Japanese Regenerative Medicine Deals Date Licensor (Acquired) Licensee (Acquirer) Therapy (Technology) Phase Territory Upfront (USD) Potential Total (USD) 13 MAY 2013 RepliCel Shiseido RCH-01 Phase Ⅰ Asia (incl. Japan) 4,200,000 35,700, SEPT 2014 SanBio Sumitomo Dainippon SB623 Phase Ⅱ North America 6,000, ,000, MAR 2015 Athersys Chugai MultiStem Phase Ⅱ Japan 10,000, ,000, JAN 2016 Athersys Healios MultiStem Phase Ⅱ Japan 15,000, ,000, MAY 2016 Celixir Daiichi Sankyo Heartcel Phase Ⅱ Japan 18,000,000??? 05 JUL 2016 TiGenix Takeda Cx601 Phase Ⅱ Ex-US Global 29,000, ,000, JUL 2016 Celyad Ono NKR-2 Phase Ⅱ Japan, Korea, Taiwan 12,500, ,500, NOV 2016 Kolon Life Science (TissueGene) Mitsubishi Tanabe Invossa Phase II Japan 24,000, ,000, NOV 2016 Steminent Biotherapeutics ReproCELL Stemchymal Phase II Japan 1,000,000 4,000, DEC 2016 Pluristem Sosei PLX-PAD Phase II Japan N/A N/A 09 JAN 2017 Kite Pharma Daiichi Sankyo KTE-C19 Phase II Japan 50,000, ,000, MAY 2015 Lonza Nikon Quality & Op System N/A Japan?????? 14 MAR 2016 PCT Hitachi Chemical CT Tech & Knowhow N/A Asia (incl. Japan) 5,600,000 25,000, DEC 2016 Regeneus Asahi Glass Progenza & Knowhow Phase I Japan 5,500,000 16,500, MAR 2015 Cellular Dynamics International FujiFilm N/A N/A N/A 307,000, FEB 2016 Ocata Therapeutics Astellas N/A N/A N/A 384,000,000 5 Reference: Company websites, various news articles Regenerative Medicine Licensing Deals Regenerative Medicine CMO Deals Regenerative Medicine M&A Deals

6 Appendix

7 CJ PARTNERS Company Profile CJ PARTNERS Inc. offers management consulting and M&A advisory services by made in Japan Americans. Our mission is to bring the assets of a unique bicultural experience to serve Japan s economy and society. Company Profile Name CJ PARTNERS Inc. Founded November 15, 2012 Managing Director Profile: Colin Lee Novick Deloitte Tohmatsu Consulting Management Consulting April, 2007 July, 2010 Address Contact Services Main Bank Tech Hiroo Bldg. 9F Hiroo Shibuya-ku Tokyo JAPAN Tel: +81-(0) Mob: +81-(0) colin.lee.novick@cj-partners.com Management Consulting, M&A Advisory Mizuho Bank, Ltd. Project Examples: SMBC Nikko Securities M&A Strategy August, 2010 November, 2012 Japan market-entry for a non-japanese regenerative medicine firm PMDA negotiation for a non-japanese cellular therapy firm Clinical trial management for a Japanese pharma firm Corporate Philosophy and Mission Statement Our Philosophy Support Japan Inc. s global strategy as an International Advisor that speaks Japan s linguistic, cultural and professional language. Mission Statement Offer cutting edge service at affordable rates Act as the missing link between Japanese and non-japanese businesses *1 Provide tailor-made global expansion strategies absent in Japanlocal advisory firms Deliver results that serve Japan s economy and society Managing Director Profile: Jason David Sieger Project Examples: Deloitte Tohmatsu Consulting Management Consulting October, 2007 September, 2011 SMBC Nikko Securities M&A Strategy October, 2011 November, 2012 JPN regulatory assistance for non-japanese pharmaceutical firms Pre-M&A DD and financial advisory services re: a JPN gene therapy firm Out-license (to Japan) assistance for a non-japanese pharma firm 7 *1: Non-Japanese businesses refers to both large, multinational enterprises and smaller, more localized foreign enterprises

8 Thanks for Listening