Introduction to Japanese Pharmaceutical Industry

Transcription

1 Introduction to Japanese Pharmaceutical Industry December 4 Japan Pharmaceutical Manufacturers Association Managing Director Akihiko Matsubara

2 Introduction to Japanese Pharmaceutical Industry CONTENTS 1. JPMA Priority (1) Evaluation of Innovation (2) Compliance (3) Support to Global Business 2. Focus moving to Emerging Markets 3. Asia Partnership Conference of Pharmaceutical Associations (1) Regulatory Convergence: Good Submission Practice (2) Drug Discovery Alliance: Open Innovation Platform (3) APAC 2016

3 1. JPMA Priority (1) Evaluation of Innovation Value Chain Discovery Research Clinical Developm ent NDA Pricing JPMA Activities Clinical Innovation Network Premium Pricing of New Product R&D Tax Incentives Request AMED accelerating Open Innovation Sakigake Priority Review HTA as Pilot in April

4 Changes in the Business Environment Surrounding Drug Discovery and Development Continued aging of population Soaring medical costs Measures to curb drug costs Promotion of generics Increasing difficulty of drug discovery and development Seeds discovery increasingly difficult Decline in success rate Scale expansion of clinical trials Reduced funding for R&D (decline in sales of long-listed drugs) Rising R&D costs Creation of innovation Evaluation of innovation 4

5 Breakdown of Drugs by Discovery Origin (No. of drugs) 1998~2007 add up data from 1998 年の集計 to 2007 Biotech firms, or university discovered, transferred to biotech firms in same country/region University discovered, transferred to biotech firms in different country/region University discovered, transferred to pharmaceutical company Small pharmaceutical company Large pharmaceutical company U.S. Japan U.K Germany Switzerland France Other Europe Canada/Australia Other 出典 Source: :Nature Nature Reviews Reviews Drug Drug Discovery Discovery, Vol.9,, Vol.9, , ,

6 Japanese Academia-discovered Drugs Researcher Drug Name Target Disease (Year Approved in Japan) Type Pharma. Company Dr. Tadamitsu KISHIMOTO Osaka Univ. Actemra (tocilizumab) Castleman's disease (2005) Rheumatoid arthritis (2008) Antibody drug Chugai Dr. Ryuzo UEDA Nagoya City Univ. Poteligeo (mogamulizumab) Adult T-cell leukemialymphoma (2012) Antibody drug Kyowa Hakko Kirin Dr. Hiroyuki MANO Univ. of Tokyo Xalkori (crizotinib) Non-small cell lung cancer (2012) Molecular target drug Pfizer Dr. Toshiyuki SAKAI Kyoto Prefectural Univ. of Medicine Mekinist (trametinib) Malignant melanoma (Japan: NDA submitted/ US:2013) Molecular target drug JT GSK Novartis Dr. Tasuku HONJO Kyoto Univ. Opdivo (nivolumab) Metastatic melanoma (2014) Antibody drug Ono, BMS 6

7 Open Innovation "Closed Innovation" ("do-it-yourself" policy) Pharmaceutical Companies "Open Innovation" connecting industry, academia, government, bio-tech companies AMED Drug Discovery Support Network Production Development Drug discovery Academia Pharmaceutical Companies Bio-tech companies Seed discovery Market launch 7

8 AMED: Japan Agency for Medical Research and Development Seamless government supports on the basic research through practical use Accelerate development of promising innovative drug seeds by collaboration between projects in AMED and innovation support network Enhance Intellectual property strategy from the phase of basic research with considerations of the practice use Upgrade Bio-Bank and other new technologies to realize genomic medical care Assure enough budget to implement effective projects/budget for 2015; JY 140 billion Industry asks for; System maintenance for information sharing and business matching for enterprises with high transparency and objectivity 出所 : 平成 26 年 12 月 8 日健康 医療戦略参与会合資料 5 日本医療研究開発機構のミッションと課題 8

9 Government s support for Clinical trials and studies Clinical Research Core Hospitals Government designates and supports core hospitals which are qualified with the hiquality clinical trials/studies for the development of innovative drugs originated in Japan. Industry expects Better patient enrollment and data collection through multicenter clinical trials/studies More efficient and reasonable procedures for clinical trials/studies Development of innovative clinical assessment methodologies * 臨床研究中核病院の承認要件に関する検討会報告書 (2015 年 1 月 30 日 ) より 9

10 New regulatory framework SAKIGAKE package New system has been introduced to facilitate the development and approvals of the innovative new drugs developed in Japan faster than in outside Japan. Industry is making every efforts to develop new drugs with innovative mode of action and the new dugs for the diseases with no effective treatment for now. 10

11 1. JPMA Priority (2) Compliance Transparency: Disclosure of Payment to HCP Code of Practice: Global Standard in line with IFPMA Competition GL: Global Standard in line with IFPMA Reputation Survey: Positive 84.2% 11

12 Transparency Initiatives with HCPs on Payment Disclosure (1/2) From Industry side, we strictly run our business in a highly transparent manner. Japan was the first in the world to initiate disclosure. Country/Region Japan United States EU Achievement of Transparency in Pharmaceutical Industry Disclosure since JPMA "Transparency guideline for the Relation between Corporate Activities and medical Institutions"(Jan 2011) First disclosure in 2014, Mar. "Sunshine Act"(2010) EFPIA member companies will start disclosure from EFPIA Code of Conduct (Jun 2013) Voluntary policy by Member companies: Each member company will establish its own internal policy based on JPMA Guidelines Disclosure method/timing: Outline of JPMA Transparency Guideline - Disclosure of Transfer of Value- Member companies started disclosure fiscal 2012 payment on their websites in fiscal 2013 Scope of Disclosure (5 categories) R&D expenses; Payments related to academic research grants; Manuscripts / Writing fee; Payments related to provision of information; Other Payments

13 Disclosure of payments in accordance with Transparency Guideline C:Manuscript/ Writing fee 5.5% D:Payments related to provision of information 29.1% B:Payments related to academic research grants 11.1% E:Other payments 2.3% A:R&D expenses 51.9% Items Amount (billion yen) % A: R&D expenses B: Payments related to academic research grants C: Manuscript/Writing fee D: Payments related to provision of information E: Other payments Aggregated of 70 JPMA companies, February 2014 Total Amount

14 Transparency Initiatives with HCPs on Payment Disclosure (2/2) Alongside with Transparent Guideline, JPMA has been conducting Trust survey on the Pharmaceutical Industry every 2 years. The result tells that approx. 80% of responses favor the pharmaceutical industry, which is higher than those of other countries (Source: JPMA Survey) Trust in the Pharmaceutical Industry Positive Responses Negative Responses 14

15 1. JPMA Priority (3) Support to Global Business Advanced Markets: Coordination with PhRMA, EFPIA And IFPMA Emerging Markets: Business Entry Supprt APAC, Bilateral Seminars Contribution to Global Health: Counterfeit Survey in Myanmar in 2014 and 2015, Proposal to G7 in

16 International co-operation Bilateral annual meetings with industry associations and/or local governments: JPMA and DoH, ABPI (18 th meeting in Nov 2015) JPMA and AIPM (Jun 2012~) JPMA and ARPM (Sep 2013~) JPMA and LEEM with CEPS, HAS (22nd meeting in April 2015) MHLW, PMDA, JPMA, MoHW, KFDA, HIRA, KPMA (13 th meeting in August 2015) JPMA and VFA (12 th meeting in Nov 2015 ) MHLW, PMDA, JPMA, NHFPC (MoH), CFDA (SFDA), RDPAC (7 th meeting in 2016 expected) JPMA and EFPIA (Feb 2012~) MHLW, PMDA, JPMA, Taiwan-FDA, CDE, industry association (3rd meeting in Nov. 2015)

17 Global Health Innovative Technology Fund The GHIT Fund was launched in April 2013, which draws on Japan s strong drug research and development capability and innovation to impact on the elimination or control of infectious disease in the developing world (http/ The first Japanese Public-Private Partnership (PPP) that aims to advance the development of new health technologies such as drugs, vaccine and diagnostics for the developing world Partners : Japanese government Ministry of Foreign Affairs, and Ministry of Health, Labor and Wealth Bill & Melinda Gates Foundation Five Japanese Pharmaceutical Companies Astellas, Eisai, Shionogi, DaiichiSankyo, Takeda, Chugai

18 2. Emerging Market 2015 IMS Health Unauthorized reproduction prohibited 18

19 Overseas Sales Ratio(2013) 19

20 Sales Breakdown by Region (JPY100M) Japanese Companies Overseas 29,555 31,651 30,968 31,163 32,975 40,850 40,520 Japanese Companies Japan 43,422 44,095 45,528 44,997 45,214 46,017 44,113 Multi Nationals Japan 21,083 22,855 23,980 26,780 27,735 28,868 NA ( 註 ) 日本企業は 2014 年 3 月現在製薬協に加盟する医薬品事業を主業とする東証一部上場企業 25 社 海外企業は製薬協に加盟する海外企業の日本法人 (2014 年 3 月時点 16 社 ) 海外企業では各社の単体売上高を日本国内売上高とみなした ( 出所 ) 日本企業有価証券報告書海外企業製薬協活動概況調査 20

21 Worldwide Ratio Trends on Aging Japan is facing an aged society that no other country in the world has yet experienced Sourece: Cabinet Office: The Aging Society: Current Situation and Implementation Measures FY 2013 (people aged 65 and over) 21

22 Medical Costs Per Person By Age (FY2012; treatment subject to public health insurance coverage) (Age) 歳 ) Medical costs Cost per patient rises with age, with patients over 65 accounting for 78% of total costs (Units: 10,000 yen) Source: Based on "Basic Information on Health Insurance System"published by the Ministry of Health, Labour and Welfare (Dec. 2014) 22

23 Generic Utilization Share of Molecule Volume Penetration of Generic Drugs Penetration rate increasing/accelerating due to government policy to promote use of generic drugs Quarters After Newly Generics Launch Source: 2015 IMS Health. Created based on IMS-Base JPM IMS Health Unauthorized reproduction prohibited 23

24 Year-on-Year Change Current State of Japanese Market Prescription pharmaceutical sales declining 3.0% 2.0% 1.2% 1.1% 1.8% 1.0% 0.0% -1.0% -2.0% Drug price revision Drug price revision -3.0% -4.0% -5.0% -4.2% Cumulative sales of prescription pharmaceuticals in Japan Apr, 2011 Mar ,500 Apr, 2012 Mar ,000 (500) Apr, 2013 Mar ,700 (700) Apr, 2014 Mar ,900 (-1,800) (Total of 22 member companies* of Japan Pharmaceutical Manufacturers Association; 100 million yen) *Scope: companies that disclosed their pharmaceutical product sales in Japan from FY2010 onward 24

25 Assessment & gap analysis Consultation with regulators Assessment of readiness 3. APAC (1) Regulations and Approvals Deliverables at 2 nd APAC Identified Issues Road Map Goal APAC Mission Concept Paper Analysis Report IND NDA Clinical Trial GMP Step Regulatory acceptance for an early initiation of multi-national clinical trials in Asia Regulatory acceptance and Co-review system for NDA Simultaneous NDA in all Asian countries Acceleration of mutual recognition of GMP inspection To expedite the launch of innovative medicines for the peoples in Asia Collaboration with relevant stakeholders (e.g. regulators) Promoting regulatory convergence in Asia would lead to achieve the APAC Mission 25 25

26 Regulatory Convergence Shorten the examination period (early approval) Efficiency of the approval and review process Good Registration Management Reviewer Regulatory Authority) Good Review Practice (GRevP) 評価者 Good Submission Practice (GSubP) Applicant (Industry) 26

27 3. APAC (2) Drug Discovery Alliance Asia Partnership Conference of Pharmaceutical Associations (APAC) To expedite the launch of innovative medicines for the peoples in Asia (held annually from 2012) Drug Discovery Alliance Promoting the expansion of seed discovery and drug development in Asia To continue developing a platform for open innovation through three core activities: the provision of opportunities for information sharing in research, the promotion of networking in development, and drug discovery capacity building for researchers. Japan Academia (collaboration/ license-out) Taiwan DSANJ DSAN-Asia DSAN-Taiwan Japan Pharma Companies (collaboration/ license-in) Taiwan DSANJ:Drug Seeds Alliance Network Japan 27

28 3. APAC (3) APAC 2016 South Korea China Japan Date April 7~8, 2016 Myanmar Hong Kong Taiwan Venue The Imperial Hotel (Tokyo) Participants Pharmaceutical associations and Regulatory authorities of 12 economies in Asia India Regulations & Approvals Thailand Malaysia Vietnam Indonesia Philippines Drug Discovery Alliance Singapore Promote active participation of pharmaceutical associations, governments and academia of Asian countries in an effort to establish 28 a new industry-academia-government partnership in Asia! 28

29 APAC Members International R&D type Association Domestic R&D type Association National Research Institute Academia Japan JPMA (OCCI) China SIMM RDPAC SINO PhIRDA South Korea KDDF KPMA KRPIA Malaysia PhAMA Thailand TCELS India NCBS Hong-Kong HKU pharmacy programm Singapore EDB SAPI Taiwan Academia Sinica DCB TRPMA IRPMA Indonesia IPMG Philippines PHAP OPPI HKAPI PReMA BIOTECH CORP RA-EWG, DA-EWG) 29

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