Development Pipeline & Key Development Projects
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1 Development Pipeline & Key Development Projects May 25, 2009 FY2008 Business Results Briefing Hotel Metropolitan Edmont Ken-ichi Yanagisawa Board Director Managing Executive Officer Development Division
2 Content Development Pipeline Status Key Development Projects Redefinition of the Global Development Organization Other Development Topics Page.1
3 Development Pipeline Status Metabolism/ Cardiovascular Immunology CNS Others Domestic < Domestic > TA-7284 (Diabetes Mellitus) TA-6666 (Type 2 Diabetes Mellitus) Cholebine (Hyperphosphatemia) MP-435 (Rheumatoid Arthritis) Cholebine (Type 2 Diabetes Mellitus) MP-513 (Type 2 Diabetes Mellitus) MCC-847 (Allergic Rhinitis) FTY720 (Multiple Sclerosis) MP-214 (Schizophrenia) Changes since October 30, 2008 : stage up Maintate (Chronic Heart Failure) CNTO148 (Rheumatoid Arthritis) Pazucross (Additional dose, Sepsis/Pneumococcus) Remicade (Crohn s disease) Remicade (Ulcerative Colitis) APTA-2217 (COPD) APTA-2217 (Asthma) MCC-847 (Asthma) VG-IH (Myasthenia Gravis) VG-IH (Systemic Sclerosis) Modiodal (OSAS) Radicut (ALS) MP-424 (Chronic Hepatitis C) Valixa (Post-transplant CMV infection) Remicade (Ankylosing Spondylitis) Remicade (Psoriasis) Remicade (Additional dose, Rheumatoid Arthritis) VG-IH (Hypo-, Agammaglobulinemia) VG-IH (IgG2 deficiency) VG-IH (Polymyositis, Dermatomyositis) Ceredist (Spinocerebellar Degeneration, OD tablet) TA-8317/ACREF (Breakthrough Cancer Pain) : stage down Neuart (Toxemia of Pregnancy) Anplag (Cerebral Infarction) Phase 1 Application withdrawn Development terminated Phase 2 Phase 3 filed Page.2
4 < Overseas > In-house developments, licensed products Changes since October 30, 2008 : stage up Metabolism/ Cardiovascular Immunology CNS Others Overseas (in-house development products) MP-124 (Stroke) MP-136 (Dyslipidemia) MCI-186 (Stroke) TA-8995 (Dyslipidemia) MP-513 (Type 2 Diabetes Mellitus) TA-5493 (Rheumatoid Arthritis, Psoriasis) GB-1057 (Stabilizing Agent) MCC-135 (Myocardial Infarction) TA-6666 (Type 2 Diabetes Mellitus) MT-2832 (Secondary Hyperparathyroidism) MCC-257 (Diabetic Neuropathy) TA-5538 (Overactive Bladder) MCI-196 (Hyperphosphatemia) MP-146 (Chronic Kidney Disease) Argatroban* (HIT)(EU) Argatroban (PCI in HIT) (EU) Phase 1 Phase 2 Phase 3 filed Overseas (main licensed products) TA-7284 (Diabetes Mellitus) T-0047 (Multiple Sclerosis) TA-1790 (Korea) (Erectile Dysfunction) FTY720 (Multiple Sclerosis) TA-1790 (US) (Erectile Dysfunction) * to be filed Page.3
5 Key Development Projects Medium-Term Management Plan US/EU MCI-196 (Hyperphosphatemia) MP-146 (Chronic kidney disease) NDA by fiscal 2010 Steady P3 progress MP-424 (Chronic hepatitis C) Steady progress Domestic MP-513 (Type 2 diabetes) TA-7284 (Diabetes) Alliances in US/EU Licensed out in US/EU RA/Change of usage/ dosage LCM Remicade Psoriasis Ankylosing Spondylitis Ulcerative Colitis Radicut ALS Approval Page.4
6 Global Development Projects (CKD) Mild Severity of Chronic Kidney Disease Severe disease stage Specialty PCP Renal Specialists Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Treatment for for CKD CKD (MP (MP-146 US/EU,, P3) P3) Challenging Prevention and Treatment of ESRD Dialysis Physicians Treatment for for Hyperphosphatemia ( MCI-196 US/EU,, P3) P3) Treatment for Type 2 DM (MCI-196 US, In Preparation of P2) Treatment Treatment for for SHPT SHPT (VD3 (VD3 Derivative Derivative CTA018 CTA018 Canada, Canada, P2) P2) SHPT: Secondary Hyperparathyroidism Page.5
7 In-house Global Developments MCI-196 Hyperphosphatemia (EU/US P3) Early Establishment of a Global development Platform MP-146 CKD (EU/US P3) MT-2832 /CTA018 SHPT(US/Can P2) MCI-196 Type2 Diabetes (US, In Preparation) (Target NDA) MPA MPE MPBJ MTPC CKD : Chronic Kidney Disease SHPT: Secondary Hyperparathyroidism MTPC:Mitsubishi Tanabe Pharma Corp. MPA: Mitsubishi Pharma America Inc. MPE: Mitsubishi Pharma Europe Ltd. MPBJ:Mitsubishi Pharma Research & Development Co. Ltd. (Beijing) Page.6
8 Redefinition of the Global Development Organization 1. Re-organization towards global development (Executing a new paradigm shift from April 2009) 2. Global and regional project team structures in response to development regions 3. Development Governance Structure 4. Globalization of the Development Process To-be Organization Governance and coordination Development strategy Portfolio management Global budget management Global resource management Global development coordination Strategic decision making coordination MTPC MTPC (Asian Dev.) MPBJ Dev. Headquarters MPA (US Dev.) MPE (EU Dev.) Regional development Development execution Regional budget management Regional resource management Practical decision making (Resource changes, CRO contracts etc.) Page.7
9 Development in Asia Improving Development Speed Preparation of of multi multi national clinical trials trials Preparation and execution of Asian Development Accelerate filing filing and and approval in in Japan Japan Asia Obtain Obtain approval in in Asia Asia Candidate Therapeutic Areas in Asia CNS CNS Diabetes Hepatic Hepatic disease disease Others Others Page.8
10 Developments in Diabetes es Product MP-513 TA-7284 MCI-196 New Compound Phase 1 Phase 2 TA-7284 Diabetes Mellitus (Japan) Mechanism of Action DPP4 inhibitor SGLT2 inhibitor Bile acid signal regulation New MOA MP-513 Type 2 diabetes (Japan/ EU) MCI-196 Type 2 diabetes (US, In preparation) Japan Overseas Japan Overseas Japan Overseas TA-7284 Diabetes Mellitus (EU/ US) Pipeline Diabetes pipelines for the various mechanisms of action Development Region and Status P2 P1 P1 P2 P2 P2 Preparation In House Alliance In House Alliance In House In House Page.9
11 Developments s in Stroke Phase 1 Phase 2 MP-124 Stroke (US) MCI-186 Stroke (EU, In preparation) Stroke development currently being conducted overseas. MCI-186, P2 preparation Clinical trials in preparation, EU MP-124 MCI-186 PARP Inhibitor, P1 Clinical trials in the US and Canada Inhibits excessive PARP activation due to ischemic DNA damage, suppressing cell death Japan Page.10
12 Maximizing ing the Value of Remicade 100M End of drug-use survey in all RA patients receiving Remicade Additional Indications for RA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 FY2002 FY2003 c 2008 IMS Japan Additional Indication for Behcet s Disease FY2004 Additional Indication for Crohn s Disease (maintenance therapy) FY2005 FY2006 FY2007 :from April 2002 to March 2009 JPM, All Rights Reserved FY2008 FY2009 RA (additional dose) filed Sep Ankylosing Spondylitis filed Sep Psoriasis filed Feb Ulcerative Colitis Crohn s disease FILED Development FY2010 Page.11
13 MP : Developments s in Chronic C Hepatitis C 12W Genotype 1 Final Results of the PROVE1 Study (SVR24) 24W 36W 48W 72W 424/PEG/RBV Follow Up SVR 24 35% (6/17) Expected HCV Gold Standard treatment of the future MP-424 Triple PEG-IFN combination Ribavirin 424/PEG/RBV PEG/RBV Follow Up SVR 24 61% (48/79) 424/PEG/RBV PEG/RBV Follow Up SVR 24 67% (53/79) PEG/RBV Follow Up SVR 24 41% (31/75) 424 : MP-424 PEG : peg-interferon RBV : Ribavirin EASL 2008 PROVE1, oral presentation, April 2008 JG McHutchison et.al Page.12
14 MP : Chronic Hepatitis C Dynamics of HCV-RNA with Chronic Hepatitis C Hepatology Research accepted Dr. F. Suzuki et al. Page.13
15 MP : Development Schedule 2004 US & EU P PROVE 1 PROVE PROVE 3 P3 (ADVANCE) Japan Licensed in P1 (PK,PD) P2 P3 Page.14
16 FTY720: Developments s in Multiple Sclerosis FTY720 overseas P3 results (one year study) Results Relapse rate with FTY720 was lower than with interferon beta-1a Serious Adverse Events (<1.5%) Bradycardia, atrioventricular block % Macular edema 0.9% Infection (Appendicitis, Herpes viral infections) 0.5% Skin Cancer (Basal cell carcinoma, Malignant melanoma) 0.7% Breast Cancer 0.5% Dyspnea 0.5% Development Status US & EU: Filing planned for the end of 2009 Japan: P2 (Novartis press release, April 2009) 52% vs IFN (p<0.0001) American Academy of Neurology Novartis: Apr. 29 th, Year Relapse Rate 38% vs IFN (p=0.0004) Page.15
17 Cautionary Statement Statements contained in this presentation are based on a number of assumptions and beliefs in light of information currently available to the management of the company and is subject to significant risks and uncertainties.
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