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Konference Onkológia Na Slovensku Konference Onkológia na Slovensku Tomáš Khorel | Head of CZ&SK Consulting Bratislava, 30 May 2019 Copyright © 2019 IQVIA. All rights reserved. Selected global Oncology trends 1 A third of global value comes from five therapy areas and they contribute over 55% of global growth Therapy area sales (2017) bn USD Share of global growth 2017 Oncologics 45% 22% 10% $110 bn 23% 36% of Antidiabetics 64% 9% 11% $82 bn 13% global Autoimmune 67% 15% $68 bn 19% value Pain 35% 15% 23% $48 bn -2% Respiratory 59% 14% 10% $44 bn 4% Antihypertensives 18% 16% 13% 26% $40 bn Antibacterials 16% 11% 48% $39 bn Anticoagulants 40% 20% $35 bn US EU5 Mental Health 49% 14% $32 bn Japan Pharmerging HIV Antivirals 67% 17% $30 bn RoW 3% 2 Onkologia na Slovensku The cancer treatment landscape has been majorly transformed since 2011 New Active Substance Launches from 2011 by Indication • Irinotecan • axitinib liposome • nivolumab • lenvatinib • cabozantinib • nivolumab • pembrolizumab • pertuzumab • ado-trastuzumab emtansine Head & Pancreatic • Palbociclib Neck Renal • atezolizumab • Abemaciclib Bladder Breast • ipilimumab • pembrolizumab • dinutuximab • vemurafenib • nivolumab Neuro- • trametinib • cobimetinib blastoma Melanoma • dabrafenib • T-vec • vandetanib, • cabozantinib • regorafenib • lenvatinib • ziv-aflibercept Colorectal Thyroid • tipiracil/trifluridine cancer • bosutinib (CML) • omacetaxine • romidepsin (PTCL, CTCL) • mepesuccinate (CML) • brentuximab vedotin • radotinib (CML) (Hodgkin’s, ALCL) GIST • obinutuzumab (CLL, FL) Lymphoma • pixantrone (NHL) • ponatinib (CML, ALL) regorafenib • rituximab (NHL) • blinatumomab (ALL) • Idelalisib (CLL, FL, SLL) • ibrutinib (CLL) • mogamulizumab (ATCL) • ofatumumab (CLL) • belinostat (PTCL) • venetoclax (CLL) Castleman’s • ibrutinib (MCL, WM) Leukemia siltuximab • bortezomib (MCL) • crizotinib • pembrolizumab • chidamide (PTCL) • afatinib • necitumumab • venetoclax (CLL) • alectinib • osimertinib • nivolumab (Hodgkin’s) • ceritinib • gefitinib Lung Ovarian • ramucirumab • atezolizumab • olaparib • nivolumab • bevacizumab • rucaparib • mifamurtide • trabectedin Cervical • eribulin Sarcoma • olaratumab • abiraterone Basal • bevacizumab acetate Prostate cell • enzalutamide carcinoma Multiple • ra 223 dichloride MPD myeloma Gastric • carfilzomib • vismodegib • pomalidomide • sonidegib • daratumumab • lxazomib • panobinostat • ramucirumab • ruxolitinib • elotuzumab 3 Onkologia na Slovensku Oncology is the innovation powerhouse of the pharmaceutical industry Top Therapy Area – Global 2018 Sales (USD) % Contribution by NAS 2014-17 Total value of TA $ 25 Bn 84 Viral Hepatitis High Innovation Turn-over HIV Innovation Powerhouses 28 26 24 Oncologics 22 20 18 16 14 12 Multiple Sclerosis 10 Autoimmune Diseases Antidiabetics 8 6 RespiratoryAgents Mental Health 4 2 Low Innovation Turn-over Innovation Peaked Anticoagulants 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 % Contribution by NAS 2010-13 5 Source: IQVIA European Thought Leadership, MIDAS Padds MAT Q4 2018, Innovative Branded New Active Substances globally launched between 2010-2017. Onkologia na Slovensku IQVIA forecasts an average of 17 new oncology products per annum FDA NCE average approvals 2014-2023 +63% 54 46 30% 24% 70% 76% 2014 – 2018 (a) 2019 – 2023 (f) Oncology Non-oncology 7 Source: IQVIA Institute, Dec 2018; FDA CDER reports 2014 –2018; IQVIA Thought Onkologia na Slovensku Leadership analysis April 2019 Oncology is the #1 growth driver and the largest therapy area Top-20 therapy area growth dynamics Top-5 therapy area ranking 20 Growth (PPG) Bubble size represents 2018 sales in US$ Oncologics 2016 - 2017 - # Therapy area 15 2017 2018 (%) Anticoagulants PPG 1 Oncology 12% 16% 10 Autoimmune 18) 18) RespiratoryAgents - World PPG HIV = 5.2% Antidiabetics 2 Autoimmune 17% 14.5% (2017 5 Mental Health Antibacterials growth 3 Anticoagulant 13% 14% 0 term Pain 4 Antidiabetics 9% 10% Antihypertensives Short Short -5 World 5yr 5 HIV 9% 7% CAGR = 6.5% -10 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Long term growth (2013-18) CAGR (%) Note: Chinese Medicines have been excluded; growth in 13 LCUS$, Rx only Source: IQVIA MIDAS MAT Q4 2018 Onkologia na Slovensku Many indications are becoming more and more complex and stratified through predictive biomarkers % of Patients Tested by Biomarker and Cancer Once tested positive for that specific biomarker,the NSCLC majority of the patients receive a drug targetingit 80% 77% EGFR (+) PD-1 (+)* ALK (+) 75% 20% 15% 16% 70% 70% 68% 65% 80% 85% 84% EGFR Inhibitor PD-1 Inhibitor ALK Inhibitor 60% EGFR ALK PD-1 Melanoma PD-1 inhibitors 94% 100% used in 31% of all BRAF (+) PD-1 (+)* NSCLC patients 80% 60% 15% PD-1 inhibitors are 35% carving out their 40% 65% segment not 23% 85% necessarily driven 20% by the biomarker BRAF Inhibitor PD-1 Inhibitor 0% BRAF PD-1 16 Note: PD-1 Positive defined as >50% expression Onkologia na Slovensku Source: IMS Real World Data, Oncology dynamics, Patient Level Oncology Survey Data. MAT Q4 2018 Countries included in analysis: France, Germany, Italy, Spain, UK. NSCLC: (Projected = ~150,100), Melanoma: (Projected =~30,200) Immuno-oncology has become the major focus of growth Checkpoint inhibitors expected to reach ~$30 billion globally by 2022 Checkpoint inhibitor forecast Immuno-oncology development highlights (Sales US$ Bn, 2018-2022) $ 37 Bn $ 33 Bn >300 immuno-oncology therapies in $ 30 Bn development, phase 1 through pre-registration $ 26 Bn 60 immuno-oncology mechanisms investigated $ 22 Bn in early-stage pipeline vs. 4* in late-stage pipeline $ 18 Bn 1/3 of IO phase 1 & 2 trials accounted for by anti-PD-1/-L1 and CD19 modulators $ 10 Bn Immuno-oncology products have shown promise in a small number of haematological cancers 2017 2018 2019 2020 2021 2022 2023 Historic sales Forecast sales 18 ® 2018 IQVIA; Source: MAT Q4 2017 US$ Analytics link; Analyst Consensus; ARK Onkologia na Slovensku * PD-1/-L1, CTLA4, CD19, (INDO) R&D Intelligence CAR T-cells, RNAi and CRISPR gene editing are the new therapy approaches – small companies dominate discovery RNAi Gene editing technologies, Number of pipeline in CAR T-cells cell and gene therapy by (RNA interference/silencing) including CRISPR Top 10 companies …are modified cells with engineered …is an efficient and stable process …are techniques which are more Phase II to Reg receptors, which graft an arbitrary in which RNA molecules inhibit gene powerful, rapid and less expensive specificity onto an immune expression or translation than any previously invented process Ionis 19 effector cell Guided Alnylam 9 RNAi new sequence J&J 8 Sangamo T-cell Therapeutics 6 modification Kite Pharma 5 DNA mRNA Protein New New DNA Celgene 3 2 5 mRNA Protein GSK 1 4 5 Key companies/partners Key companies/partners Key companies/partners Novartis 2 3 5 Novartis, Celgene, Merck, Amgen, Ionis, Alnylam, Sanofi Genzyme, Caribou Biosciences, CRISPR Pfizer, Servier, GSK, Gilea/Kite BMS, Quark Pharmaceuticals, Therap., Editas Medicine, Intelia Sanofi 5 Pharma, Juno, Cellectis, Celyad Sylentis Therap., Regeneron, Novartis, Vertex, Bayer, Juno AGTC 4 Key therapy areas Leukemia, cancer Key therapy areas Key therapy areas Cancer, hepatitis, ophthalmological Rare genetic diseases, cancer, HIV, Cell therapy Gene therapy disorder organ transplants Onkologia na Slovensku Look in recent past – Slovakia in 2018 10 SUMMARY Oncology landscape in Slovakia has been benchmarked with several EU countries to help with assessment of its development Country benchmarking Geographical coverage in the report1) Market Cancer Economic Quantitative Qualitative Country performance burden assessment onco analysis onco analysis Austria Role models ✓ ✓ ✓ ✓ France Role models ✓ ✓ ✓ Germany Role models ✓ ✓ ✓ ✓ Netherlands Role models ✓ ✓ ✓ ✓ Slovenia Role models ✓ ✓ ✓ ✓ Czechia Peers ✓ ✓ ✓ ✓ Hungary Peers ✓ ✓ ✓ ✓ Poland Peers ✓ ✓ ✓ ✓ Bulgaria EU28 ✓ ✓ ✓ Romania EU28 ✓ ✓ UK EU28 ✓ ✓ Role models Peers Slovakia EU28 1) Selection of the scope countries has been defined by the Patient Association – Nie Rakovine 11 Onkologia na Slovensku CANCER BURDEN IN SLOVAKIA Cancer to become the top killing disease in Slovakia Causes of death – Slovakia Rate of deaths by causes, 2016 [per 100k inhabitants]2) Years of life lost, 2016 [per Commentary 100k inhabitants] 2) • In Slovakia, and still 2010-2016 2016 globally, Cardiovascular trend diseases are top deadly Cardiovascular dieseases 497 45,4% 6.874 diseases, causing the most deaths • At the same time, the world is seeing fatality rates of CV Neoplasms (Cancer) 239 33,5% 5.079 fall, while Cancer rates grow, which will potentially bring Cancer related deaths Neurological disorders 52 4,1% 626 in Slovakia to the top • Cancer has already become top deadly disease in some Diabetes, urogenital, blood, and 34 3,9% 594 of the EU countries – endocrine diseases France (since 1998), UK, Italy, Spain and many Chronic respiratory diseases 20 2,2% 326 more1) • This report has been designed to assess, if Slovak healthcare system Other 56 9,4% 1.426 is ready for the challenge… Source: 1) European Heart Journal, Volume 37, Issue 42 - Cardiovascular disease in Europe: epidemiological update 2016 2) Global Health Burden - http://ghdx.healthdata.org 12 Onkologia na Slovensku CANCER BURDEN IN SLOVAKIA …and while cardio is going down thanks to better access to innovative drugs, oncology threat is growing Cancer impact on society – Slovakia Years of life lost (YLLs) index, 2010-2016 Commentary [2010 as a 100% index] •
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