Cardiovascular and Metabolism Peter M. DiBattiste, M.D.

Transcription

1 Cardiovascular and Metabolism Peter M. DiBattiste, M.D. Global Therapeutic Area Head

2 Note on Forward-looking Statements These presentations contain forward-looking statements as defined in the Private Securities Litigation Reform Act of The viewer is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; complex global supply chains with increasing regulatory requirements; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson s Annual Report on Form 10-K for the fiscal year ended December 30, Copies of this Form 10-K, as well as subsequent filings, are available online at or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.

3 Notice Regarding Non-GAAP Statements These presentations may refer to certain non-gaap financial measures. These non-gaap financial measures should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. A reconciliation of these non-gaap financial measures to the most directly comparable GAAP financial measures can be found in the Investor Relations section of the Company s website at Note: Operational sales growth excludes currency impact and is a non-gaap financial measure.

4 New Molecular Entities These presentations contain statements about new molecular entities ( NMEs ) and other medicines or line extensions in various stages of development. These statements are based on the Company s current knowledge of the status of development of these NMEs, medicines and line extensions and are subject to the challenges and difficulties inherent in product development. The Company assumes no obligation to update any statements regarding these NMEs, medicines or line extensions as a result of new information or future events or developments. In addition, in biopharmaceuticals, there are higher possibilities of encountering infringement claims by competitors with respect to patents or other intellectual property rights.

5 Strategic Partnerships, Collaborations and Licensing Arrangements During the course of this morning s presentations, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships that are not otherwise referenced in today s presentations. Immunology Neuroscience Infectious Diseases & Virology Cardiovascular/ Metabolism REMICADE and SIMPONI marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation, ASP015K-JAK Inhibitor licensed from Astellas Pharma Inc., Sirukumab developed in collaboration with GlaxoSmithKline. INVEGA SUSTENNA /XEPLION includes technology licensed from Alkermes, Inc., NUCYNTA co-developed with Grunenthal GmbH, RISPERDAL CONSTA developed in collaboration with Alkermes, Fulranumab licensed from Amgen, Inc., Bapineuzumab is being developed through a collaboration between Janssen Alzheimer Immunotherapy and Pfizer Inc., Bace Inhibitor Prodormal Alzheimer s disease licensed from Shionogi & Co., MGluR2 PAM developed in collaboration with Addex Therapeutics, NR2B licensed from Evotec, MGluR5 PAM developed in collaboration with Vanderbilt University, AAB-003 and AAC-001 developed in collaboration with Pfizer, ULTRAM ER licensed from Grunenthal GmbH, TRAMACET developed in collaboration with Grunenthal GmbH, AXERT licensed from Almirall Prodesfarma, REMINYL is licensed from Shire PLC., LEXAPRO co-marketed and license agreement between Xian-Janssen and Lundbeck A/S, INCIVO developed in collaboration with Vertex Pharmaceuticals, Simeprevir (TMC435) developed in collaboration with Medivir AB, Darunavir/cobicistat fixed-dose combination developed in collaboration with Gilead Sciences, Inc., LEVAQUIN licensed from Daiichi Sankyo Co., Ltd., QUINVAXEM developed in collaboration with Novartis Vaccines and Diagnostics, HIV Vaccine developed in collaboration with Beth Israel Deaconess Medical Center and National Institutues of Health, (NIH), Rabies mab co-promoted with Sanofi Pasteur, FlumAb partially funded by NIH. INVOKANA licensed from Mitsubishi Tanabe Pharma Corporation, XARELTO co-developed with Bayer HealthCare. Oncology Ibrutinib (PCI-32765) developed in collaboration and upon approval will be co-marketed with Pharmacyclics, Inc., ZYTIGA licensed from BTG International Ltd., VELCADE developed in collaboration with Millennium: The Takeda Oncology Company, DACOGEN developed in collaboration with Eisai Corporation of North America, Daratumumab licensed from Genmab A/S, YONDELIS developed in collaboration with Pharma Mar S.A., Intetumumab licensed to and co-developed with BeiGene, Ltd., PROCRIT /EPREX licensed from Amgen Inc., FGFR Inhibitor is licensed from Astex Pharmaceuticals, Inc.

6 What We Strive to Do Make a difference globally for the millions of people living with diabetes and cardiovascular disease 2

7 Our Strategy to Bring Innovations to Patients Build on strong foundation of XARELTO and INVOKANA Focus on diabetes and heart failure Identify underlying disease mechanisms, important pathways, and novel mechanisms of action Invest in cutting-edge science, internally and externally 3

8 The Growing Diabetes Epidemic >371 million people currently live with diabetes worldwide million people with diabetes projected by $471 billion spent in >$565 billion projected in Many current therapies fail to prevent end-organ damage 1. IDF Diabetes Atlas 5 th Edition, 2012, 4

9 Diabetes: A Large and Growing Worldwide Market 2012 WW Diabetes Market $36.2B Insulin T1D $3.6B, 10% Insulin T2D $15.4B, 42% Source: EvaluatePharma. Includes type 1 and type 2 diabetes. Type 1 diabetes sales is about 19% of the insulin market. Other $1.4B, 4% DPP4 $6.6B, 18% GLP-1 $2.4B, 7% Biguanide $1.0B, 3% Sulfonylurea $1.4B, 4% DPP4 + Biguanide $2.0B, 6% AGI $0.9B, 2% PPAR $1.5B, 4% 2017 WW Diabetes Market $56.7B Insulin T1D $5.0B, 9% Insulin T2D $21.3B, 37% PPAR $0.3B, 1% AGI $0.8B, 1% CAGR : 9% Other $2.5B, 4% DPP4 $12.5B, 22% GLP-1 $5.6B, 10% SGLT2 $1.6B, 3% Biguanide $1.1B, 2% Sulfonylurea $1.4B, 3% DPP4 + Biguanide $4.6B, 8% 5

10 INVOKANA (canagliflozin) A New Way of Treating Type 2 Diabetes Novel, oral, once-daily SGLT2 inhibitor for treatment of patients with type 2 diabetes First-in-class approval in the US Greater glucose lowering with INVOKANA 300mg relative to glimepiride and Januvia Upcoming regulatory action dates Single Agent: EMA Q3 Fixed-dose combination with metformin immediate-release: US Q4, EMA Q

11 Adding to the Johnson & Johnson Legacy in Treating Diabetes D E V E L O P M E N T C O R P O R A T I O N 7

12 INVOKANA Novel Mechanism of Action Blocks Glucose Reabsorption Glucose in the bloodstream Proximal tubule in the kidney Glucose in the bloodstream Glucose passing through the kidney of a patient with type 2 diabetes Glucose SGLT2 SGLT2 inhibitor Glucose passing through the kidney of a patient with type 2 diabetes on an SGLT2 inhibitor Increased loss of glucose through the urinary tract 8

13 LS Mean Change from Baseline (%) LS Mean (%) Change from Baseline Superior Reductions in HbA1c and Body Weight INVOKANA 300mg vs. Januvia (sitagliptin) 100mg HbA1c Change Body Weight Change 0.0 SITA 100mg INV 300mg 2.0 SITA 100mg INV 300mg % 0.1 kg % * % -2.3 kg * % Time Point (week) *P<0.001 Time Point (week) *P<0.001 Significantly greater HbA1c and weight reductions with INVOKANA vs. Januvia Sustained benefits of INVOKANA over 52 weeks Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin Compared With Sitagliptin for Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With Metformin Plus Sulfonylurea: A 52-week randomized trial. Diabetes Care Apr 5. [Epub ahead of print] 9

14 LS Mean Change from Baseline (%) LS Mean (%) Change from Baseline Durable Effect on HbA1c and Weight INVOKANA vs. glimepiride HbA1c Change Body Weight Change 0 GLIM INV 100mg INV 300mg 2 GLIM INV 100mg INV 300mg kg * * Time Point (week) % -0.82% -0.93% * ** *P=NS **P< Time Point (week) -4.2kg -4.7kg *P<0.001 Data presented at American Diabetes Association William T. Cefalu, Lawrence A. Leiter, Leo Niskanen, John Xie, Dawn Millington, William Canovatchel, Gary Meininger, Abstract Title: Efficacy and Safety of Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Compared with Glimepiride in Patients with Type 2 Diabetes on Background Metformin. 10

15 Low Incidence of Hypoglycemia INVOKANA vs. glimepiride Hypoglycemia Incidence Percentage of trial participants GLIM INV 100mg INV 300mg * 34.2 * *P<0.001 Data presented at American Diabetes Association William T. Cefalu, Lawrence A. Leiter, Leo Niskanen, John Xie, Dawn Millington, William Canovatchel, Gary Meininger, Abstract Title: Efficacy and Safety of Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Compared with Glimepiride in Patients with Type 2 Diabetes on Background Metformin. 11

16 INVOKANA : Exploring New Opportunities STRATEGIC DRIVERS Expand understanding of SGLT2 and the role of the kidney in diabetes Establish effects on beta cell function and insulin sensitivity Understand intra-class pharmacology differences Ambulatory blood pressure Enhance prescriber knowledge Metformin XR FDC * Add-on to DPP-4i Add-on to insulin FDC initial use indication * Opportunities under consideration in adjacent diseases Obesity * Type 1 diabetes * Durability of glycemic control * Potential new indication. Programs underway. 12

17 Transforming the Treatment of Diabetes Patients Focusing on Disease Interception and Prevention Prevent disease progression Beta cell preservation and proliferation Beta cell replacement Reversal of insulin resistance Target diabetic complications End-organ protection 13

18 Preventing Disease Progression Beta Cell Preservation and Regeneration Strategic collaboration with Harvard and Evotec to explore small molecules and biologics designed to trigger the proliferation of insulin-producing beta cells Beta cell functionality and mass are critical to glucose regulation Potential to prevent and reverse the disease 14

19 Preventing Disease Progression The Potential of Cell Therapy in Diabetes Focusing on cell therapy using stem cells to create pancreatic islet cells Pancreatic cells are contained in a device that is implanted subcutaneously Potential to eliminate the need for insulin and normalize glucose 15

20 Preventing Disease Progression Reversing Insulin Resistance Researching protein factors that mimic the potential glucoregulatory effects of bariatric surgery Potential to correct a key defect in type 2 diabetes and improve metabolic control Collaboration with NGM Biopharmaceuticals Bariatric Surgery 16

21 End-Organ Protection First-in-Class Antibody Addressing Diabetic Complications Targets a novel pathway that is stimulated by hyperglycemia Potential to reduce the need for dialysis and incidence of cardiovascular and kidney-related death Innovative collaboration model with Vascular Pharmaceuticals, Inc. 17

22 Heart Failure The Last Horizon of Cardiovascular Disease Eugene Braunwald, M.D. Chronic, progressive condition Heart unable to meet body s demands Final pathway of many cardiovascular diseases Approximately 5.7 million people in the US alone have heart failure 1 Current therapies are inadequate Most frequent cause of hospitalization and re-hospitalization among older patients 1. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics 2012 update: A report from the American Heart Association. Circulation. 2012;125(1):e

23 Heart Failure Costs Continue to Rise Direct and Indirect Costs in the US ($ billions) Data from Medicographia Volume 33, number 4,

24 Transforming the Treatment of Heart Failure Disease-modifying treatments are needed to impact long-term outcomes Develop deep understanding of the underlying diseases Match the right therapy to the right patient Priority areas for exploration Restoring cardiac function Cardiac repair and regeneration Cardiac, vascular, and renal protection 20

25 A Novel Approach to Heart Failure Treatment Auto-antibodies against the β1-adrenergic Receptor promote heart failure by continuous receptor activation Y β1 receptor auto-antibodies Conventional therapy with β-blockers is not effective Norepinephrine ECII Pursue precision medicine through development of companion diagnostics to identify responders P Gα S * ATR 21

26 A Novel Approach to Heart Failure Treatment β1-adrenergic Receptor Auto-Antibody Program Acquired Corimmun and lead asset, (JNJ ) A small cyclic peptide that mimics the β1-adrenergic Receptor JNJ-2840 JNJ-2840 JNJ-2840 Potential to modify disease Companion diagnostic to identify responders Norepinephrine JNJ-2840 ECII Gα S * P ATR 22

27 XARELTO Oral Factor Xa inhibitor (rivaroxaban) Broadest Profile of Any Novel Oral Anticoagulant Once-daily dosing in currently approved indications * No routine INR monitoring On-going investment in new indications * With exception of 15mg BID dosing for treatment of acute DVT or PE. 23

28 XARELTO (rivaroxaban) The Most Studied Oral Factor Xa Inhibitor with the Broadest Indications INDICATIONS RANDOMIZED PATIENTS VS. COMPARATOR STUDY PROGRAM STATUS DVT/PE prophylaxis after knee surgery DVT/PE prophylaxis after hip surgery 12,729 patients vs. enoxaparin Approved Stroke/systemic embolism in patients with nonvalvular AF 1 14,264 patients noninferiority vs. warfarin Approved DVT treatment PE treatment Prevention of recurrence of DVT and/or PE 2,3 >9,000 patients vs. enoxaparin and warfarin/acenocoumarol Approved Thrombotic risk reduction post-acs 4 >15,000 patients in addition to standard therapy Filed (complete response) VTE primary prevention in medically-ill patients 5 ~8,000 patients vs. enoxaparin A total of 60,000 patients in Phase 3 studies alone Investigational 1. Patel MR et al. N Engl J Med. 2011;365(10): EINSTEIN Investigators. N Engl J Med. 2010;363(26): EINSTEIN-PE Investigators. N Engl J Med 2012;366(14): Mega JL, et al. N Engl J Med. 2012;366: Cohen AT et al. N Engl J Med. 2013;368:

29 New Oral Anticoagulants Will Drive Growth CAGR : 21% 2012 US Sales $2.2B Heparin $0.1B Novel Oral Anticoagulants $0.3B 2017 US Sales $5.6B Other Inj. A/C $0.7B Heparin $0.2B Other Inj. A/C $0.6B Warfarin $0.1B LMWH $0.6B Warfarin $0.1B LMWH $1.1B Novel Oral Anticoagulants $4.0B Source: EvaluatePharma, May

30 XARELTO : Clinical Efficacy in ACS ATLAS ACS TIMI 51 Study CV DEATH / MI / STROKE CARDIOVASCULAR DEATH ALL CAUSE DEATH Estimated Cumulative Incidence (%) Estimated Cumulative Incidence (%) Estimated Cumulative Incidence (%) 12% HR % HR % HR 0.64 Placebo mitt p=0.039 ITT p= % 9.0% mitt p<0.001 ITT p< % 2.5% mitt p<0.001 ITT p< % 2.7% XARELTO 2.5mg BID Months NNT=71 Months NNT=59 Months NNT=56 Jessica L. Mega, M.D., M.P.H., Eugene Braunwald, M.D., Stephen D. Wiviott, M.D., Jean-Pierre Bassand, M.D., Deepak L. Bhatt, M.D., M.P.H., Christoph Bode, M.D., Paul Burton, M.D., Ph.D., Marc Cohen, M.D., Nancy Cook-Bruns, M.D., Keith A.A. Fox, M.B., Ch.B., Shinya Goto, M.D., Sabina A. Murphy, M.P.H., Alexei N. Plotnikov, M.D., David Schneider, M.D., Xiang Sun, Ph.D., Freek W.A. Verheugt, M.D., and C. Michael Gibson, M.D., for the ATLAS ACS 2 TIMI 51 Investigators*, Rivaroxaban in Patients with a Recent Acute Coronary Syndrome, NEJM, Vol.366 No. 1 26

31 XARELTO : Building on Our Investment POTENTIAL NEW INDICATIONS COMMANDER-HF: In patients with chronic heart failure and coronary artery disease COMPASS: In patients with coronary artery disease or peripheral artery disease ADDITIONAL DATA IN COMPLEX PATIENT GROUPS PIONEER-AF: In patients with atrial fibrillation who have a percutaneous coronary intervention X-veRT: In patients with nonvalvular atrial fibrillation and need to undergo cardioversion VENTURE-AF: In patients with nonvalvular atrial fibrillation and need to undergo ablation 27

32 Cardiovascular and Metabolism Portfolio Innovating from Our Successes APPROVED PRODUCTS Stroke risk reduction in nonvalvular atrial fibrillation (AF) US DVT treatment US PE treatment US Prevention of recurrence of DVT and/or PE US DVT/PE prophylaxis after knee surgery US DVT/PE prophylaxis after hip replacement surgery US Type 2 diabetes PRODUCTS IN REGISTRATION OR PLANNED FILINGS FILED INVOKANA Type 2 diabetes (EU) Fixed dose with metformin IR XARELTO (US) Acute coronary syndrome (complete response) Stent thrombosis PLANNED FILINGS INVOKANA Fixed dose combination with metformin XR (US) Initial therapy with fixed dose with metformin XARELTO (US) Congestive heart failure ADDITIONAL NMEs UNDER DEVELOPMENT* HEART FAILURE β1-adrenergic Receptor Auto-Antibody (JNJ ) * Filings expected beyond Filings/approvals assumed to be in US, EU unless otherwise noted. This information is accurate as of the date hereof to the best of the Company s knowledge. Johnson & Johnson assumes no obligation to update this information. 28

33 Cardiovascular and Metabolism Making a Difference for Millions of Patients Strong foundation of innovative products Clear focus on diabetes and heart failure Pursuing transformational therapies that will change the practice of medicine 29

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