Life Science Industries in Osaka Overview, strength and challenges, for future innovations

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1 Life Science Industries in Osaka Overview, strength and challenges, for future innovations KANSAI (Greater Osaka) Kyoto Shiga Hyogo Nara Mie Osaka Prefecture JAPAN Wakayama Illinois Science + Technology Park September 13, 2012 Satoko Sako Executive Director, City of Osaka Chicago Office

2 Chicago & Osaka Sister Cities since 1973 (40 th anniversary in 2013) Osaka Garden, Jackson Park Chicago Gallery Osaka Int l Airport Sister School Exchanges Kobe Airport Kansai Annual Social Int l Service AirportExchanges Kansai Int l Airport

3 Leading Industries and Companies in Osaka Green Technology & New Energy Panasonic Corporation etc. Nanotechnology Effluent treatment facilities Daikin Industries, Ltd. etc. Pharma Teijin Ltd. Hosokawa Micron Group Sumitomo Chemical Co. Food and Beverage Nissin Foods Holdings Co., Ltd. Game software developer Capcom Co., Ltd Sport-utility Mizuno Corporation Osaka: Capital of manufacturers Robot Vstone Co.,Ltd. etc. National Institute of Biomedical Innovation Takeda kd Pharmaceutical lco.,ltd. etc.

4 Kansai s Share of Drug and Medical Device Share The Nation s Largest Share of Pharmaceutical Drug Production (29%) Second Largest Share of Medical Device Production(17%) Pharmaceutical Drug Production Medical Device Production billion dollars total (1$ = 80Yen) billion dollars total (1$ = 80Yen) Census of Manufacturers FY2009 By Ministry of Economy, Trade and Industry

5 Pharmaceutical Companies in Kansai Eli Lilly Japan K.K. Asbio Pharma Co. Ltd. Novartis Pharma K.K. SYSMEX CORPORATION Nippon Boehringer Ingelheim Co., Ltd. Kyoto Pharmaceutical Industries, Ltd. Nippon Shinyaku Co., Ltd. Ohkura Pharmaceutical Co., Ltd. Kansai International Airport (KIX) Osaka Bay Headquarters Factory Research Institute Taisho Pharmaind Ltd. Ohara Pharmaceutical Co., Ltd TAKARA BIO INC. MSD K.K Otsuka Pharmaceutical Co., Ltd Takeda Pharmaceutical Co., Ltd. Shionogi Co., Ltd., Mitsubishi Tanabe Pharma Corp. Dainippon Sumitomo Pharma Co., Ltd.. Maruho Co., Ltd. Kobayashi Pharmaceutical Co., Ltd. Wakunaga Pharmaceutical Co., Ltd. TOWA PHARMACEUTICAL Co., Ltd. Bayer Yakuhin, Ltd. Hospira-Japan Inc. Nipro Pharma Corp. Sawai Pharmaceutical Co., Ltd. AstraZeneca K.K. Ono Pharmceutical Co. Ltd. Senju Pharmaceutical Co. Ltd. FUSO pharmaceutical Industries Ltd. Fujimoto Pharmaceutical Corp. Tsuruhara Pharmaceutical Co., Ltd. Maruishi Pharmaceutical Co. Ltd. Nippon Zoki Pharmaceutical Co. Ltd. Ono Pharmaceutical Co. Ltd. Ueno Fine Chemical Industry,Ltd. Santen Pharmaceutical Co., Ltd. Rohto Pharmaceutical Co., Ltd. 5

6 Medical Devices Companies in Kansai Sysmex Corporation Kaneka Corporation Konan Medical, Inc CHUO SANGIO CO. JCR Pharmaceuticals Co.,Ltd AIR WATER SAFETY SERVICE INC. OPHTECS Corporation Eli Lilly Japan K.K. Kansai International Airport (KIX) Shimadzu Corporation OMRON Corporation OMRON HEALTHCARE CO SHOFU INC. SUN CONTACT LENS Co, Ltd. TERAMECS Co,Ltd SHOKEN Inc. Osaka Bay HOYA CORPORATION SHIGA SHOFU INC. ARKRAY, Inc. Ormic Corporation YAMASHO CO.,Ltd TAKARA BIO INC Nipro Pharma Corp. DAIKEN MEDICAL CO.LTD Kaigen.CO.KTD Kobayashi medical Co.LTD YAMAMOTO VINITA CO.LTD YUYAMA MANUFACTURING CO.LTD KYOCERA MEDICAL corporation Family Co., Ltd FEATHER Safety Razor Co., Ltd Takazono Corporation MINATO MEDICAL SCIENCE CO.,LTD KAWAMURA GISHI CO.,LTD Kaneka Corporation ASAHI INTEC CO Hitachi Medical Corporation THE YOSHIDA DENTAL MFG.CO.,LTD Headquarters Factory Research Institute 6

7 Northern Osaka Biomedical Cluster National Institute of Biomedical Innovation(NIBIO) Kyoto Hyogo (12.4 mil radius) Osaka International Airport (ITM) Lake Biwa Shiga Osaka University, Faculty of Medicine Est.1931 Excellent Univ.,& Research Institutes Osaka University, Institute for Protein Research Osaka Bio Headquarters / / Osaka Bay Kansai International Airport (KIX) Wakayama Saito Life Science Park(LSP) Est.2004 Shin Osaka Station Osaka City Over 300 pharma companies Home to pharma industry for 350 yrs Nara * New industrial park is scheduled to open in 2015 next to the Saito LSP Leading Companies Saito Bio Innovation Center National Cerebral and Cardiovascular Center Est Incubation facilities in the Saito LSP Saito Bio Hills Center Saito Bio Incubator operation in Kansai over 200 Univ./institutes over 150 bio ventures 7

8 Japan s status quo and challenges Japan s pharma industry: - the highest ratio of value added to sales among all industries. - heavy reliance on the domestic market. Shift in Domestic Pharma Industry s Recurring Profit Margin to Sales Domestic Pharma Industry s percentage share between domestic and overseas sales A large difference in earning power Pharma Industry average All Industry average domestic overseas (Data Source) the website of the Development Bank of Japan

9 Japan s status quo and challenges Japan s national medical treatment system Medical cost is covered/shared among government, health insurances(companies and individuals), and patients Annual average medical cost per person by age range Shirts in Japanese national s medical costs (1),their scale to Japan s GDP (2), their rate covered by government (3) Shift in National import and export of pharma drugs import With the aged population expanding, aged generation s medical cost surging export (1) (2) (3) Government s share jumped up to 37.5% ($17 bil.), which is 15% of the national government s total budget of Surging drug imports result in a massive trade deficit it in pharmaceutical trade (Data Source) the website of the Development Bank of Japan

10 Japan s status quo and challenges The process of new drug development & financing for pharmaceutical venture companies Drug Development Steps and Terms Basic Research Pre clinical Trial Phase I Phase IIa / IIb Phase III Approval Commercialization Univ., RI Venture Venture, Big pharma Patent Technology Transfer License Contract 2 ~ 3 yrs 3 ~ 5 yrs 4 ~ 7 yrs 1 ~ 2 yrs Effective Patent t Term : 20 ~ 25 yrs Patent Monopoly Public research funds, founders, grants, angel and public VC 10 Ms to 10X2Ms yen = 10X2 Ks to Ms $ Fund and Capital Sources * Pharma companies fund with VC in many cases VC, etc, VC, etc, Licensing contract with pharma companies 300 to500m yen = 4M to 6M $ 2 to 3B yen = 25M to 38M $ Over 10B yen = over 125M $ (1$ = 80Yen) IPO (Source) the website of the Development Bank of Japan Lack of - professional talent: intermediary, legal and license consultation, coordination, and capital management - globalization: global talents, partners, and alliances -government support shifting from infrastructure to industry needs funding, peer-review, deregulation

11 from the latest news clip Foreign Medical Firms Expanding Presence in Japan (NIKKEI September 4, 2012) -The Japanese government is set to further deregulate the medical sector as a key part of the Japan Revitalization Strategy it adopted in late July. In line with these developments, foreign manufacturers are stepping up their efforts to expand in the world s second-largest drug and medical equipment market, after the U.S. - the Health, Labor and Welfare Ministry i launched a program in 2007 to help screen applications. Under this system, the Japanese, U.S. and European authorities simultaneously conduct clinical tests to determine product safety and potential effects. This data is then shared between the authorities in each region. - Now that a new screening system is in place, foreign medical equipment manufacturers are increasingly focusing on the Japanese market.

12 Building Global Business Network: Hub-Node Minnesota Hub Nodes: Univ. & RI Hokuriku Sub Fukushima Sub Nodes: Medical device Companies Nodes: Other related Industries Kansai Hub Nodes: Government and regulatory Kanagawa Sub

13 The Kansai Innovation International Strategic Comprehensive Special Zone Further strengthen local innovative industries globally through the creation of The Innovation Platform (A framework to seamlessly foster new break-through innovations from commercialization to the global market)...through entire Kansai collaboration beyond local governments boundaries...through reaching out and incorporating in and out knowledge and resources Pharma Drug Medical Device Advanced Medical Technology Preemptive Medicine Battery Smart Community GOAL by Double global l share of fdrugs and medical ldevices exported dfrom Kansai - Drastic increase of production value of battery in Kansai Billion Yen Billion Yen

14 Kansai Innovation International Strategic Comprehensive Special Zone 9 areas, each with focusing on one or a few of the following industries. 1)pharma, 2)medical device, 3)advanced medical technology, 4)preemptive medicine, 5)battery, 6)smart community Harima Science Garden City area SPring-8 SACLA Kobe Biomedical Innovation Cluster Osaka Univ. Saito Northern Osaka area Clinical Research Center for Medical Equipment Development, Kyoto Univ. Kyoto area research institutes concentration area Kobe Biomedical Innovation Cluster area Hanshin Port area Yumeshima & Sakishima area Osaka Stn. area Umekita (Phase 1 Development area) Kansai Science City area communal constant temperature warehouse for medical products Kansai International Airport area KIX Medica

15 What is expected in the Comprehensive Special Zone National Tax incentives Investment tax allowance Corporation tax credit of 15% of newly purchased machinery price or 8% of a newly purchased building price Special depreciation (=exemption) Addition of 50% of newly purchased machinery price or 25% of a newly purchased building price to common depreciation Income deduction (=tax exemption) Inclusion of tax deuctible expenses of 20% of taxable income earned by the business operated exclusively in the special zone by using preferential measures for regulations (for five years) One of the above three options shall be applied in each FY.

16 Tax Incentives by Osaka local governments No Local Tax Collaborative tax incentives with Osaka Prefectural and Osaka City Governments drastically cut off tax burden than ever Prefecture Tax Applicable Area Kansai Innovation International Strategic Comprehensive Special Zone ; and Osaka Prefecture Tax to be reduced (=exempted) Corporate enterprise tax, Corporate inhabitant tax & Real estate acquisition tax Applicable reduction (=exemption) Initial 5 years: 100% exempted Additional 5 years: 50% exempted (subject to detail terms & conditions) Eligible Projects Projects related to New Energy and Life Science (details to be confirmed) Application Procedure Application should be submitted by March 31, 2016 City Tax Real estate tax, urban planning tax, corporate inhabitant tax and business office tax are to be applied for exemption

17 Enhancement of Evaluation System and Clinical Trial in Kansai Number of top level basic research results born in Kansai Japan s low positioning in clinical research turn outs in lack of speedy clinical i l trial and screening process Essential projects for prompt practical application i of research Implementation of PMDA-WEST function (cooperating with PMDA) Establishment of the Clinical Trial Center Osaka Univ. Hospital Clinical Trial Center (Virtual network) Expected medical institutions cancer, cardiovascular disease and regenerative medicine i National Cerebral and Cardiovasc ular center Osaka Medical Center for cancer and cardiovasc ular diseases Osaka National Hospital Kyoto Univ. Hospital, Translationa lr Research Center, Cancer Center PMDA: Pharmaceuticals and Medical Devices Agency Establishment of consistent system of clinical studies and trials Data Diversion Enables efficient collection of goodquality clinical trial data Clinical trial stage Early stage clinical study Clinical study Clinical trial center PhaseⅠ PhaseⅡ PhaseⅢ Market PhaseⅣ Seamless procedures of clinical trials!

18 Sate-of-the-art medical technologies in Kansai 18 1) ips cell bank (Kyoto Univ.) 2) Commencement of myocardial regenerative Potential in ips cells Cell transplantation (regenerative g medicine) ips cell bank Skin cells from patient Differentiation induction Neuron cell Myocard Liver Pancreat ial cell cell ic cell Evaluation of clinical condition, developing drugs and adverse reaction Shinya Yamanaka Center for ips Cell Research and application Kyoto Univ. medicine involving cell sheets Clinical trials by Osaka Univ. and Terumo Corp. 4) Regenerative Medicine by ips cell (RIKEN) 3) Regeneration of Cornea by 4) Regenerative Medicine by Oral mucosa (Osaka Univ.) Koji Nishida Graduate school of Medicine Osaka Univ. Yoshiki Sawa Cardiovascular surgeon Osaka Univ. Myocardial sheets by temperatureresponsive culture dish Targeted to be industrialized within 5 years Masayo Takahashi RIKEN/ Foundation for Biomedical Research and Innovation

19 Commercialization platform of medical devices 19 OCCI(Osaka Chamber of Commerce & Industry) s efforts to create medical device industry supporting core in downtown Osaka (near the Osaka station) Enhancement of supporting medical device development such as organizing the Forum for Industrialization of Next Generation Medical System Osaka Univ., Kyoto Univ., Kobe Univ., University Hospitals, National Cerebral and cardiovascular center collaboration Backup R&D of Medical Devices Medical Device/ Manufacturing companies support for Fukushima s recovery projects (Fukushima Prefecture, Fukushima medical college) Examples of Projects funded from the grant for Special Zones by the National Cabinet Office 1 Development and Improvement of Integrated Next Generation Medical Devices for global standardization of endoscopic therapy Osaka Univ. Consulting Construction of the Support Function of Medical Device Development/Practical Application Funding International cooperation Image of irrigation suction catheter with electrosurgical knife 2 Development and Clinical application of endoscopes fine and steerable Kyoto Univ.

20 Projects in Green Innovation (Battery & Smart Community) 20 Kansai Science (Keihanna) area Opening of the smart community Improving of the function of the innovation center 3 areas in Battery and Smart Community The World s largest Yumeshima and Northern-Osaka area Sakishima areas Improving of Battery Strategy Research Center Evaluation of safety and quality Creation of new demand Making a model of smart community from a green field (a vacant land: Toshiba- cho, Ibaraki City), which is profitable in working infrastructure third-generation synchrotron radiation facility SPring-8 The next-generation supercomputer K computer X-ray free electron laser SACLA Development of Open Innovation Center former- Vocational Museum (closed March 2010) to be transformed into a main hub for the projects related to smart community in whole Kansai area Improving the function of joint research and liaison Research and Experiment of energy management system making use of terminals of EV battery charge Image of of Experiment Waste power generation Image of operation in emergency Solar panel Elevator light battery transmission power to gather all results of research and development of the projects related to smart community in whole Kansai area to accelerate international i competitiveness i by leading new technological development and international standardization Examples of joint researches Joint researches with universities and companies research on new material related Research on wireless EV battery charge to smart community (nanotechnology) research on smart battery charge research on smart agriculture research on smart healthcare, etc Solar power generation Management center Distribution board light plug gym PC Mobile (One Seg TV) Charge radiostudent lamp charge EV charger and discharger discharge Car Sharing using for charge EVs Emergency back up

21 Kansai working together for moving forward! Supporting Systems by local governments put info effect ahead of national government Tax incentives No Local Tax Osaka Pref. Gov., Osaka City Gov. 100% reduction for initial 5 years and 50 % reduction for additional 5 years Reduction in real-estate estate tax, subsidy for rents Kobe City Gov. Subsidies Excellent subsidy systems for establishing new business facilities Kyoto Pref. Gov., Osaka Pref. Gov., Hyogo Pref. Gov., Kyoto City Gov., Kobe City Gov. Subsidy systems focused on foreign-affiliated companies Kyoto Pref. Gov., Osaka Pref. Gov., Hyogo Pref. Gov. Whole strategy management Budgetary measures 2. Operation Scheme The Regional Council for the Kansai International Strategic Comprehensive Special Zone Regional Council Management in the region Committee Determination of enforcement projects of whole Kansai Feedback of achievement from projects advice di Information sharing Introduction of mega solar, research and attraction of next generation plant factory(budget in 2012: 162million yen) Kyoto Pref. Gov. Improvement of the function of Battery Strategy Research Center (budget g in 2012: 47million yen) Osaka Pref. Gov. Support for R&D on Harima Science Garden City and other industrial premises (budget in 2012: 284million yen) Hyogo Pref. Gov. Promotion in business creating in health and medical fields(robot technology and healthcare)(budget in 2012: 124million yen) Osaka City Gov. Promotion in using K Computer(budget in 2012: 275million yen) Kobe City Gov. advice Advisory Board Support for cooperation among regions Set up an office for promoting ot the special zone to strengthen local government s secretariat functions (May, 2012)! Implement of the PDCA cycle on the progress each fiscal year through discussions at regional councils and advisory board! Contact us if you are interested in Kansai Special Zone Contact Information Bureau of Regional Council of Kansai International Strategic Comprehensive Special Zone tel (0) fax +81 (0)

22 Subsidy for foreign-affiliated companies into Osaka Eligibility Non-Japanese company establishing a new headquarters or a gateway office to Asia in Osaka Contents of subsidy 5% of buildings/facilities cost (max: up to 100 million yen) or 1/3 of building rent (max: for 2 years, up to 60 million yen) *The amount subject to the number of full-time employees Conditions To secure office floor space of at least 250m2 and a workforce of at least 25 employees (to be achieved within 3 years after the application). Evaluation of the business plan should be required.

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