Case studies for technology trading and marketing cooperation in Japan Mineo Mori, Assistant General Manager Summit Pharmaceuticals International Corporation • • • • • • Food and Beverages €133,000,000 Japan Region License for resminostat Pharmaceuticals April 2011 MISSION 4SC discovers and develops targeted small-molecule therapies against inflammation & cancer towards approval and/or commercialization FINANCE& SHARES Founded in 1997 Market cap. ≈ €93 m (24 May 2012) Prime Standard listing (@ Deutsche Börse) since 2005 History 2004 SPI starts agency work in Japan 2005 Sanwa Kagaku Research Collaboration, 1st deal in Japan 2009 4SC/SPI start introduction of resminostat in Japan 2011 Yakult License Agreement for Japan for resminostat ATTRACTIVE GOALS Vidofludimus: Phase IIb study in IBD in preparation AHEAD Resminostat: Pivotal program in preparation YAKULT SALES OF PHARMACEUTICALS Major in-licensing activities (Billions of yen, Fiscal year) 2001 Debio Oxaliplatin 45 40 2005 Oxaliplatin launch in Japan 35 2007 Agennix Satraplatin (Phase 3) 30 25 2008 Celsion ThermoDox (NDA, US) 20 2009 KHK Neu-up G-CSF (Marketed, JP) 15 2011 Proacta PR509 (Preclinical) 10 5 2011 Aeterna Perifosine (Phase 3, US/EU) 0 Zentaris 2011 4SC Resminostat (Phase 2, EU) Oral HDAC inhibitor potential to be used for solid tumors To be presented on site CONFIDENTIAL • • • • • CONFIDENTIAL SPI supported 4SC on licensing €133,000,000 arrangement with Yakult [Key turning points] • Introduction to Yakult Japan Region License • Leading TS initiation to full for resminostat agreement discussion • Spot-on advices on full agreement • Maintain reliable communication at critical events April 2011 • Convince both parties towards partnering MISSION Evotec offers services and alliances based on its state-of-the-art technology platform and a broad range of integrated capabilities spanning the drug discovery process. History • Founded in 1993, Evotec BioSystems AG goes public in 1999 • SPI start its agency work in 2002 • The agency work is focused on Contract Services Projects to date: 41 projects in Japan Major components of service: Screening Services, Assay development, Chemistry Project (LB synthesis), Medicinal Chemistry Services, Library Management, KINAXO services 2002-2004 Screening services (hERG assay) 2005-2007 Screening, Chemistry Project 2008- Size of deal Screening(especially FBDD approach to Med Chem, EuroMs for several years), expansion to Proteomics 1. Key factors to success compared with the other agencies or direct marketing) • Accumulation of steady works identifies Japanese customer’s needs • Budgeting of each project is generated by researchers and take formal steps to be authorized internally. • SPI is trying to collect information about each company’s research strategy. Marketing of wide-range clients enable us to contact various researchers. • Actually succeeded in agency work in Pharmaceutical research field • SPI has more than 30 years history with many track-records. • Long-term collaboration is possible 2. Difficult part of contract service business in Japan Takes long time to get budgeting in Japanese companies. Long-term persistent work is necessary to get a deal in Japanese companies. Metabolite analysis GPCR profile services Early stage product Antibody licensing Humanization Fragment Based Contract Manufacturing Drug Discovery Arrangement of biopharmaceuticals Regular base meeting with research planning dept. SPI can access to many range of information through our usual communication with Company X $272,000,000 Asian Region License Asian Region License for RTA- 402 for RTA- 402 January 2010 January 2010 Currently 2,000 patient Phase 3 study Nephrology ESA (Erythropoietic Stimulating ESPO®, NESP® products Agent) preparation Agent for secondary REGPARA®, hyperparathyroidism Rocaltrol® MISSION Reata is the leader in developing a novel class of oral anti- inflammatory drugs, Antioxidant Inflammation Modulators (AIMs), which are potent activators of the biological transcription factor Nrf2. FINANCE Founded in 2002 Private company in Texas, USA History 2007 Found RTA-402 (bardoxolone) ‘s potency to CKD 2008 SPI starts agency work in Japan 2010 KHK License Agreement for Japan and Asian countries Projects Bardoxolone: US/EU Phase III study in CKD on-going JAPAN Phase IIa study in CKD on-going Follow up compounds : Phase I in preparation 2006 Reata initiated a Phase 1 trial of RTA 402 in solid tumors 2007 Found RTA-402 (bardoxolone) ‘s potency to CKD 2008 Two phase 2a studies with RTA402 initiated in CKD Autumn SPI starts agency work in Japan 2009 Spring Announce Positive PIIa result at ADA 2010 Jan Reata Licenses Bardoxolone to KHK in Asian territory Abbott and Reata Announce Agreement to Develop and Commercialize Sep Bardoxolone for CKD Outside the U.S. 2011 June Reata and Abbott Initiate Global Phase 3 Study Abbott and Reata Announce Agreement to Develop and Commercialize Dec Next-Generation AIMs CONFIDENTIAL • • • • • CONFIDENTIAL $272,000,000 $272,000,000 • Support to Reata Pharmaceuticals on licensing arrangement with Kyowa Hakko Kirin • Support supply chain management Asian Region License Asian Region License for key API’s required for for RTA- 402 for RTA- 402 manufacturing of RTA-402 [Key turning points] • Preparative work before TS January 2010 • Spot-on advices on full agreement • Advice on time keeping TARGET SCREENING HITS Æ LEADS Pc PI PII P III NDA LAUNCH • • • • • • • • • • • • • Bio Japan World Business Forum • BIO Asia International Conference • BIO tech • Soffinova Biopharma Partnering Conference http://www.takedaventures.com/ http://www.astellasventure.com/ http://www.mp-healthcare.com/ • • • • Debt Partnering Marketing API/manufact Direct Origin Loan Support Support uring support Investment service SPI/Sumitomo SPI SPI Oxford Sumitomo Corporation Pharmaceutical SPI SC group Finance Corp. “SOGO SHOSHA” License dept. Investment Bank Financial Advisors (Support) Partnering Consultants Trading Companies 26 • • • • • • Agenda 1. SC Corporate Profile 2. MS Group Business overview Sumitomo Corporation Head Office Corporate Profile Sumitomo Corporation is one of the leading firms in the Japanese business arena, with its business continuously expanding into a diverse range of products and services. Since its foundation in the early 17th century, the “Sumitomo” Brand has represented stability and trust. The company’s reputation has been built upon the strong foundation of its long business tradition. Date of Establishment December 24, 1919 Number of Offices 116 overseas (65 countries), 24 in Japan Consolidated Subsidiaries 560 (421 overseas, 139 in Japan) Associated Companies 230 (176 overseas, 54 in Japan) Total Trading Transaction : US$ 101 billion Gross Profit : US$ 11.2 billion Net Profit : US$ 3.2 billion SC Head Office Total Assets : US$ 88 billion Shareholders’ Equity: US$ 20.6 billion Number of Employees : 5,100 (72,030 including consolidated subsidiaries) * ¥82=U.S.$1 (as of March 2012) Global Network CIS EUROPE headed by Sumitomo Corporation Europe Holding Limited NORTH Sumitomo Deutschland GMBH AMERICA MIDDLE EAST & AFRICA ASIA & OCEANIA JAPAN Overseas: 64 countries Japan: CENTRAL AMERICA Subsidiaries 40 / 88 locations Headquarter 1 / 1 location AND SOUTH AMERICA Branch 1 / 1 location Subsidiaries 3 / 9 locations Offices 25 / 25 locations Regional Business Units 3 / 12 locations Total 114 locations Offices 2 / 2 locations Total 24 locations Sumitomo Corporation Europe Holding Limited/ Sumitomo Deutschland GMBH Sumitomo Corporation Europe Holding Limited History : Nov 1955 Set up Liaison office in London Apr 1985 Establish Sumitomo Corp. UK Jan 1999 change to Sumitomo Corp. Europe Holding Headquarter : London Employees : 319 Founding cap. : Euro 254,124,000 Sumitomo Deutschland GMBH History : Jan 1952 Set up Liaison office in Hamburg Nov 1952 Move to Dusseldorf from Hamburg Apr 1958 Establish Sumitomo Deutschland Sep 2001 Spin off Pharmaceutical business to Summit Pharmaceuticals Europe Headquarter : Dusseldorf Employees : 54 Founding cap. : Euro 30,610,964 Business Activities in Germany by Sumitomo Deutschland GMBH Trade Investments Offices in Germany Sumitomo Deutschland GmbH Sumitomo Exports ¾ Machinery & Deutschland GmbH Equipment ¾International transportation Georg-Glock strasse 8 Dusseldorf, Germany from (NVOCC) Tel:+49- 211-45-700 Germany ¾Organic Chemicals service (Sumisho Global Logistics Sumisho Global Logistics Europe GmbH Imports ¾Automotive Europe Georg-Glock strasse 8 Dusseldorf, Germany Components Tel:+49-211-45-70-290 to GmbH) Germany ¾Agrochemicals ¾Organic & Function Sumi Agro Europe Ltd Chemicals Zweigniederlassung Deutschland (German Branch) ¾Non-ferrous Products Sumisho Global Sumi Agro Georg-Glock strasse 8 Dusseldorf, Germany ¾Machinery & Logistics Europe Ltd, Tel:+49-211-45-70-206 Equipment Europe GmbH German Branch Sumisho Global Logistics Europe GmbH Touch Panel Solar panel Automotive Parts for Navigation and Polysilicon in its raw state (right) and International transportation (NVOCC) service Entertainment modules. as a sliced wafer. Solar panels are Start from 1991 made by laying processed wafer cells side-by-side. Business Unit in SC Mineral Resources, New Industry Metal Products Infrastructure Energy, Chemical & Development Electronics & Cross-function Medical Science Dep. Transportation & Media, Network & General Products & Construction Systems Lifestyle Retail Real Estate Organization of Life Science Business Unit Mineral Resources, Energy, Chemical & Electronics Business Unit San Cristobal Mineral Mineral Basic Electronics Life Science Energy Project Resources Resources Chemicals Business Division Division Division No.1 Division No.2 Division Division Division Agri-Science Dept Medical Science Dept Pet Care Science Dept Brazilian Pesticide Company, Pharmaceutical Ingredient Pet Care Products Manufacturer, joitnly invested with Japanese Trading & License Business, one of the leading Pet Care Agriscience Global bases Company in US. Agrichemicals Distribution Minority Investment to Chinese Ceva Animal Health LLC / US , Companies, with Global Pharmaceutical Company JV to Sales to Animal Health to Networks in EU, Asia, LA. Veterinarians. US Debt Financing company into Agrichemicals Distribution new Technology at new Bio- division headquarter at Tokyo. Technologies Cosmetic Ingredient Formulation & Distribution Company in the US Summit Pharmaceuticals Europe Establishment : Jan 1997 as spin off of Sumitomo Corporation Europe Headquarter : Vintners’place - London Branches : Milano – Madrid Main Activity : UK, Italy, Spain, Germany, Switzerland, Belgium, etc. Employees : 18 Founding cap. : GBP 1.614.000 Total turnover : Euro 34 mil. SPE Organization Corporate Management Dept (Milano) Commercial Dept No.1 (London) C.E.O New Dev. (biology, licensing, etc) Commercial Dept No. 2 (Milano) Cosmetic Biz Commercial Dept No.3 (Madrid) Agenda 1. SC Corporate Profile 2. MS Group Business overview Overview • Strong network in Key area of Pharmaceutical business with more than 200 experienced staffs strategically located • Accumulate experience to coordinate Pharmaceutical business with more than 40 years track record throughout every medical life • High reliability based on the basis of Sumitomo business spirit with more than US$ 300 million of trading transactions in the world Strong global network of SC and MS group Summit Pharmaceuticals China Summit Pharmaceuticals Europe Sumitomo Corporation of Korea Sumitomo Corporation of America London Milanan Milana g Beijing Mila M M M M M M M M Mi M M M M M M M la Mila Milan Madrid Madrid Nanjing Nanjing Tokyo Tokyo New York Shanghai Osaka Osaka Seoul Seoul Seoul Seou Mumbai Mumbai Sumitomo Corporation Medical Science Group Ch Chennai i Chennai Summit Pharmaceuticals International Sumitomo Corporation India SC Overseas Offices and Subsidiaries SC Sumitomo Corpor Sumito itomo Corporation Subsidiaries porati MS Group Overseas Offices and Subsidiariesation Subsidiaries and Offices sidiar ffices s Offi es z Sumitomo Corporation Subsidiaries and Offices MS Group Overse Offices nd Subsidiaries p MS Gro p Ove as Office and Subsidiaries z MS Group Overseas Offices and Subsidiaries z MS Group Overseas Offices and Subsidiaries More than 200 experienced staffs are strategically located to add our precious values to both customers and suppliers. Many experiences: multi-functional services TARGET SCREENING HITS Æ LEADS Pc PI PII P III NDA LAUNCH Production, Marketing Supply of FDF, APIs, Intermediates Direct Investment Providing Debt Licensing of New Drugs and Diagnostics Research Collaboration Chemical Library MS Group turnover is over US$ 300s mil / y of multi transactions in the world pharmaceutical sector. Case Study a) API Supply Chain Coordination b) Research Collaboration, with Metabolon Inc. c) Pharmaceutical company in China, C&O Pharmaceutical Case Study 1 - Supply Chain Coordination Local presence, accumulated experience and integrated information enable us • to select cost-competitive and reliable supplier • to monitor supplier’s performance and progress • to ensure on-time supply Raw Material API, FDF EU CHINA KOREA JAPAN US INDIA SC Intermediate API Case Study 1 - Supply Chain Coordination Sumitomo global network Advanced Raw Customer Sumitomo API Intermediate Material SPE can provide seamless supply chain with advantages of - Save unnecessary cost of each trader, vendor - Ensure on time delivery by controlling all suppliers at once - Monitor each supplier’s performance and progress at once Trader Trader Vendor Vendor CMO Advanced Raw Customer Intermediate Material API Case Study 2 - with Metabolon Inc. Science and technology-driven company providing solutions through global biochemical profiling Mebabolon Overview Clients; • Founded in 2000 • 1400+ studies • Over 125+ employees worldwide • Pharmaceuticals, Biotechs, Govt. agencies, Academic groups • New 37,000 sq. ft. facility in RTP, NC • Over 1,400 completed projects Application; • Over 55 peer-reviewed publications • Disease Mechanism, Diagnostics, Bioprocessing, Cell Culture, • 19 issued patents Biomarkers, Vaccines, Agriculture, • Advanced metabolomic technology Nutrition, Toxicity, Drug safety, Compound Profiling Case Study 2 - with Metabolon Inc. DNA Biochemistry Advantages RNA Any sample type Proteins Many applications OH OH O Fewer total O OH OH HO OH OH NH 2 Metabolism biochemicals glucose cholesterol L-threonine Disease Solutions through Mechanism Understanding Metabolism Case Study 2 - with Metabolon Inc. Complex Biological Metabolite Analysis of Biochemistry Solution Question Data Benign Prostate Cancer Sarcosine modulates Aggressiveness invasiveness Localized Metabolon 800 0 800 400-800 Software als/ als/ biochemicals/ e sample Z-score Metastatic Ø Hundreds of thousands ion features/study Case Study 3 - C&O Pharmaceutical History : Funded in 1999, listed in Singapore Exchange in Oct. 2005, SC joined in Dec.’10., Shionogi joined in Oct.’11. Turnover : HK$650mil. (US$83mil. , FY09) Employee : 1,300 (sales900, R&D100, admi.100, prod.200) Products : 28 C&O branded products, 7 imported products Development : 25projects of category1(new drug in the world) & category3(new drug launched in other markets, not in China) are under develop, Focus on Anti-Infective, Adult Disease, Digestive, and Anti-Tumor. Specialties : - Exclusive distributor of ¾ Meiji Seika’s Cefditoren pivoxil “Meiact” ¾ Shionogi’s Latamoxef “Furumarin” - Extensive network covering over 300,000 hospitals, clinics and pharmacies with 900 sales persons - Joint Venture CRO service – XBL China Case Study 3 - C&O Pharmaceutical SPE support to maximize business possibility from Europe to China with • licensing out the market the compounds developed by European partners • helping development work as CRO • supplying competitive/reliable API Licensing EU CHINA/ C&O API SC We hope to support your business by utilizing our competitive functions from the point of view of diversity. Thanks for paying your attention.
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