Cardiovascular & Metabolism James List, M.D., Ph.D. Global Therapeutic Area Head, Cardiovascular & Metabolism

Transcription

1 Cardiovascular & Metabolism James List, M.D., Ph.D. Global Therapeutic Area Head, Cardiovascular & Metabolism Cardiovascular & Metabolism 1

2 Our Vision for the Future To improve the lives of the millions of people with cardiovascular disease and diabetes, and to work tirelessly to eliminate these diseases Cardiovascular & Metabolism 2

3 Overwhelming Burden of Disease 19 Million People a Year Die from Cardiovascular & Metabolic Diseases¹ Cardiovascular Venous Thromboembolism Atrial Fibrillation Coronary Artery Disease/ Acute Coronary Syndrome Peripheral Arterial Disease Heart Failure Metabolism Type 2 Diabetes Type 1 Diabetes Obesity Pre-diabetes Diabetic Kidney Disease 1. World Health Organization. Global Health Estimates: Deaths by Cause, Age, Sex and Country, Geneva, WHO, Cardiovascular & Metabolism 3

4 Cardiovascular & Metabolism Portfolio Innovating from Our Successes APPROVED PRODUCTS PRODUCTS IN REGISTRATION OR PLANNED FILINGS PLANNED FILINGS BY 2019 Type 2 diabetes Stroke risk reduction in non-valvular atrial fibrillation (AF) US Deep vein thrombosis (DVT) treatment US Pulmonary embolism (PE) treatment US Prevention of recurrence of DVT and/or PE US DVT/PE prophylaxis after knee replacement surgery US DVT/PE prophylaxis after hip replacement surgery US * Filings expected beyond Type 2 diabetes (US) Type 2 diabetes (OUS) INVOKANA Fixed dose combination with metformin extended release (XR), including initial therapy US Initial therapy with fixed dose combination with metformin immediate release (IR) US Type 1 diabetes mellitus Fixed dose combination with phentermine for obesity XARELTO (US) Congestive heart failure Embolic stroke of undetermined source (ESUS) Peripheral arterial disease Medically ill Pediatric venous thromboembolism SELECTED ADDITIONAL PROGRAMS* INVOKANA Diabetic kidney disease Pre-diabetes XARELTO (US) Acute coronary syndrome JNJ-375 ( Ichorcumab ) Monoclonal Ab for thrombosis prevention and treatment JNJ-076 (GPR40 agonist) Type 2 diabetes Cell therapy Diabetes New Molecular Entities Line Extensions Cardiovascular & Metabolism 4

5 Janssen s Leadership in Cardiovascular & Metabolism Target underlying disease mechanisms, important pathways, and novel mechanisms of action Novel oral anticoagulants (NOAC) and SGLT2 inhibitors are two classes with exceptional growth Building on our cornerstone products XARELTO, INVOKANA, and INVOKAMET /VOKANAMET Cardiovascular & Metabolism 5

6 New Oral Anticoagulants Will Drive Growth CAGR : 9.7% 2014 US Sales: $4.4B 2019 US Sales: $7.0B Heparin $0.2B Novel Oral Anticoagulants $2.9B Novel Oral Anticoagulants $6.1B Other Inj $0.7B Warfarin $0.1B LMWH $0.5B Heparin $0.2B Other Inj $0.3B Warfarin $0.05B LMWH $0.4B Source: EvaluatePharma April Cardiovascular & Metabolism 6

7 Thrombosis Venous thromboembolism kills more people each year than motor vehicle accidents, breast cancer and HIV combined 1 Nearly a million additional patients with atrial fibrillation are recommended for treatment with blood thinners 2 Factor Xa inhibitors are an important advance in anticoagulation What will it take to continue to lead the thrombosis market? Continue to scientifically and commercially lead the novel anticoagulant market Lead the science in anticoagulation 1. National Heart Lung and Blood Institute. Pulmonary Embolic Disease and CTEPH Research: Executive Summary. 2. JAMA Intern Med. 2015;175(5): Cardiovascular & Metabolism 7

8 XARELTO (rivaroxaban) Most Prescribed Novel Oral Anticoagulant in the United States Oral Factor Xa inhibitor with no routine monitoring Once-daily dosing for atrial fibrillation and other indications Most broadly reimbursed in the US Currently approved for six indications Studied in over 85,000 patients XARELTO is a registered trademark of Bayer AG. Cardiovascular & Metabolism 8

9 XARELTO : Consistent Safety in Real-world Setting Post-marketing Safety Surveillance (PMSS) Study Evaluating Major Bleeding in Patients Receiving XARELTO in a Real-world Clinical Setting EVENT PMSS: NON-VALVULAR ATRIAL FIBRILLATION COHORT (N=27,467) Major bleeding, n (%) 478 (1.7) GI bleeding, n (%) 423 (1.5) Intracranial hemorrhage, n (%) 36 (0.1) Fatal bleeding, n (%) 14 (0.1) Cardiovascular & Metabolism 9

10 XARELTO : Growth Through Innovation SUPPORTIVE DATA IN CURRENT INDICATIONS AND PROJECTED TRIAL COMPLETION DATES PIONEER-AF: Atrial fibrillation and percutaneous coronary intervention 3Q 2016 X-veRT: Atrial fibrillation and cardioversion completed VENTURE-AF: Atrial fibrillation and ablation completed EINSTEIN CHOICE: High risk for recurrent venous thromboembolism (VTE) 4Q 2016 POTENTIAL NEW INDICATIONS AND PROJECTED TRIAL COMPLETION DATES COMMANDER-HF: Chronic heart failure and coronary artery disease 2Q 2017 MARINER: Medically ill patients that are at high risk for VTE 1Q 2017 NAVIGATE ESUS: Embolic stroke of undetermined source 1Q 2018 VOYAGER PAD: PAD and peripheral artery interventions 1Q 2019 EINSTEIN JUNIOR: Pediatric VTE GEMINI ACS1: Recent acute coronary syndrome 1Q 2017 In Phase 3. Cardiovascular & Metabolism 10

11 JNJ-375: Next Generation Anticoagulant Janssen Pharmaceuticals, Inc. acquired XO1 Limited and its lead asset JNJ-375 on March 19, 2015 Recombinant human antibody developed to mimic activity of a human antibody Appears to produce an anticoagulated state with a wider therapeutic window than existing therapies Clot Weight (mg) (rat femoral vein) Blood Loss (mg) (rat tail clip) Dose (mg/kg) Cardiovascular & Metabolism 11

12 Expanding Non-Insulin Diabetes Market CAGR : 10.2% 2014 WW Non-Insulin Diabetes Market $19.5B DPP4 $10.6B 55% 17% 5% 7% 6% 4% GLP-1 $3.4B SGLT2 $1.0B AGI $0.8B PPAR $0.6B, 3% Sulfonylurea $1.3B Biguanide $1.1B Other $0.7B, 3% 2019 WW Non-Insulin Diabetes Market $31.6B DPP4 $15.1B Other $0.6B, 2% 48% 23% 17% 4% GLP-1 $7.3B SGLT2 $5.4B AGI $0.7B, 2% PPAR $0.4B, 1% Sulfonylurea $1.2B Biguanide $0.9B, 3% Source: EvaluatePharma April Cardiovascular & Metabolism 12

13 The Growing Diabetes Epidemic 387 million people around the globe living with diabetes million people with diabetes projected by $1 out of every $9 spent globally in healthcare is on diabetes 1 SGLT2 inhibitors are the first truly transformational class of drugs to enter the diabetes market in almost a decade What will it take to continue to lead the diabetes market? Continue to scientifically and commercially lead the SGLT2 inhibitor market Find and develop new ways to treat diabetes and end-organ damage Discover and develop ways to intercept diabetes 1. IDF Diabetes Atlas 6 th Edition, Cardiovascular & Metabolism 13

14 INVOKANA (canagliflozin) Changing the Treatment of Diabetes Oral, once-daily SGLT2 inhibitor for treatment of patients with type 2 diabetes INVOKANA approved in 65 countries INVOKAMET /VOKANAMET (canagliflozin/metformin HCl tablets) approved in 35 countries Averaging one approval a week since initial approval Cardiovascular & Metabolism 14

15 INVOKANA : A Differentiated SGLT2 Inhibitor At the 300 mg dose, INVOKANA is the only SGLT2 inhibitor with demonstrated superiority in A1C reduction vs. sitagliptin¹ and glimepiride 2,3 Greater glucose excretion vs. dapagliflozin hr Urinary Glucose Excretion (g) P< Diabetologia 56: , Lancet 382: , Slide updated post May 20 th DAPA 10mg CANA 300mg Diabetes, Obesity and Metabolism 17: , Cardiovascular & Metabolism 15

16 INVOKANA : Innovating for the Future GROWTH DRIVERS TYPE 2 DIABETES WITH PROJECTED TRIAL COMPLETION DATES POTENTIAL NEW INDICATIONS WITH PROJECTED TRIAL COMPLETION DATES DISEASE INTERCEPTION Potential Submissions Additional Data Diabetic kidney disease 1 (CREDENCE DNE3001) 1Q 2020 Pre-diabetes 1 Fixed dose combination (FDC) with metformin extended release, including initial therapy 1 completed Add-on to DPP-4 (DIA4004) 3Q 2015 Add-on to basal insulin 2Q Type 1 diabetes mellitus 1 (DIA2004) 2Q 2015 Obesity 1 (OBE2002) 2Q 2015 Initial therapy with FDC with metformin immediate release 1 (DIA3011) completed Ambulatory blood pressure (DIA4002) 2Q 2015 CANVAS/CANVAS-R (DIA3008/DIA4003) 3Q Potential submissions. In Phase Corrected post May 20 th from 3Q2015 to 2Q2017 Cardiovascular & Metabolism 16

17 Blood Glucose (mm) Cell Therapy in Diabetes Using stem cells to create pancreatic islet cells that will be contained in a device implanted subcutaneously Potential to eliminate the need for insulin and normalize glucose Reversal of Diabetes in Mouse Models with Human Cells 25 hesc Tx 20 STZ Nat Biotechnol. 32(11): , Day 180 Cardiovascular & Metabolism 17

18 Diabetic Kidney Disease Nearly 1/3 of diabetes patients will develop diabetic kidney disease (DKD) ¹ DKD is associated with 36% mortality rate over a five-year period ² Initiated the first and only Phase 3 study evaluating an SGLT2 inhibitor, INVOKANA, in patients with type 2 diabetes and diabetic kidney disease CREDENCE trial Partnership with Vascular Pharmaceuticals, Inc. to study V β 3 integrin blockade for diabetic kidney disease 1. Cleveland Clinic. Diabetic Nephropathy. Available: 2. Q J Med 2002; 95: Cardiovascular & Metabolism 18

19 Innovation Leadership in Metabolics Energy Balance Microbiome Insulin Sensitivity Diabetes Cross Sector Innovation Beta Cell Function Biomarkers Cardiovascular & Metabolism 19

20 Janssen Cardiovascular & Metabolism Continued Leadership for Growth Deep scientific expertise and clinical development capabilities Significant scientific and commercial growth runway with XARELTO, INVOKANA and INVOKAMET /VOKANAMET Focus on transformational therapies that address the underlying mechanisms of cardiometabolic diseases Cardiovascular & Metabolism 20

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