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Improving Cancer Outcomes: Challenging Pre-Conceptions and Shared Goals

Explore the vital statistics of the pharmaceutical industry and potential future focus areas as we strive to improve cancer outcomes. Join Professor Andrew Hughes, Chair of Experimental Cancer Medicine at the University of Manchester, at the Wales Cancer Conference on November 24th, 2017.

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Improving Cancer Outcomes: Challenging Pre-Conceptions and Shared Goals

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  1. NHS and Industry Improving cancer outcomes: Challenging pre-conceptions and delivering shared goals Professor Andrew Hughes Chair Experimental Cancer Medicine, University of Manchester Wales Cancer Conference November 24th 2017

  2. Overview #1 Vital statistics of the pharmaceutical industry #2 Potential future focus areas as the industry tries to improve cancer outcomes #3 Challenging pre-conceptions and delivering shared goals

  3. #1 Vital Statistics: Oncology sector 1. What % pharma market share is Oncology: 2.5%, 5%, 10%, 20% 2. What interest rate is predicted on pharma money invested in oncology: 2.5%, 5%, 10%, 20% 3. In the last decade of 20th century, the oncology market grew: 2x, 3x, 4x, 5x 4. In the first decade of 21st century, the oncology market grew: 2x, 3x, 4x, 5x 5. Today, the oncology market is worth: 50, 75, 100, 150 $BN

  4. Oncology: Better to invest than put your money in the bank

  5. Global Cancer Market tripled 1990-2000

  6. Global Cancer Market set to triple again by 2010 90. 80. 70. 60. Vaccines 50. Immunostimulants $bn Gene Therapy 40. Supportive Care 30. Novel Approaches Hormonals 20. Cytotoxics 10. 0. 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Key market segments: Cytotoxics ($7.5bn), hormonals ($4.4bn) and supportive therapies ($6.2bn) Source: Oncology B&MR latest view

  7. 12% 1% 9% -3% -1% Growth driven by biologics and targeted agents Market size$ Billions CAGRPercent 324 277 Rheumatology* 44 40 Respiratory Oncology CV 89 86 CNS 2008 2014E • Global therapeutics market valued at $70B in 2009; $90B by 2016 • Targeted therapies largest (~50%) and fastest growing segment *Decision resources Pharmaview

  8. Global Cancer Sales ($bn) by Region 90 80 70 RoW 60 Japan 50 $bn Europe 40 US 30 20 10 0 1999 2001 2003 2005 2007 2009 2011 2013 2015 US Represents 50% Global Cancer Market US contribution expected to increase as highly priced new treatments launched and adopted first in the US Source: Oncology B&MR latest view

  9. Competition to source patients for cancer clinical trials will increase Market access will be increasingly challenging due to cost pressures in markets 3 7 #2: Potential future focus areas as the industry tries to improve cancer outcomes Trends 1 The market will be hyper-competitive, with big players investing heavily in R&D 2 R&D focus will completely change, moving towards personalised medicine and molecular targeting Competitive intensity will increase with multiple targeted molecules per indication 4 5 Opportunities to in-license late stage oncology compounds will be more difficult to find due to increased demand and limited compounds- more focus on scientific partnering 6 Pharmacos will increasingly look to Asia for new markets where the prevalence of diseases such as stomach and liver cancer is higher

  10. 8 Oncology R&D investment by individual players $ bn, 2008 The market will be hyper-competitive, with big players investing heavily in R&D 1 Total oncology R&D investment by top 20 companies $ bn 18 CAGR 15% 11 6 4 6 Development 3 2 Research 1 1996 2000 2004 2008 SOURCE: Evaluate 2008; Pharma Projects August 2008; Research and Development spend estimated as a 30/70 split from reported total R&D spend

  11. 7 2 Market access will be increasingly challenging due to cost pressures in markets CASE STUDY: UK AND FRANCE More than 60% of NICE decisions have been restrictive or negative with rationale in most cases due to both cost and clinical reasons Only 15% of drug assessments in France achieved the best case market access scenario Best case Middle Worst case HAS access scenarios achieved,% NICE decisions for each product assessed 100% = 609 100% = 284 Negative Positive 1 37 15 84 Restrictive SOURCE: McKinsey HTA research; interviews; press clippings

  12. 3 R&D focus will completely change, moving towards personalised medicine and molecular targeting Current-2013 2013-18 Beyond 2018 • Few tests widely used • Limited to high-risk patients and common diseases • Whole-genome screening limited • 10s of new markers developed • Whole-genome screens may start to be used for “rational benefit design” Risk markers • Whole-genome screening becomes standard • Little biomarker activity • Emerging activity for imaging • A few early-stage Dx will come on the market in select TAs, e.g., oncology • Limited to common diseases • Expanded development of early-stage Dx across areas Early-stage diagnostics • Development of general toxicity diagnostics (e.g., Warfarin) • Approx less than 5% of drugs launched with a companion diagnostic • Limited to oncology, ID, and RA • Approx 10%-15% of drugs launched with companion Dx, approx 30% in some TAs (e.g., oncology) • Expansion to new TAs, e.g., CVD, antipsychotics, and CNS • New technologies will start to drive tailored Rx (tailored antibodies, gene therapy) • % of drugs with Dx unknown • Majority of TAs ripe Companion diagnostics Note: DTC – direct to consumer; Dx – diagnostic; Rx – treatments; TA – therapeutic areas; MIAs – XXX SOURCE: Expert interviews 2013 12

  13. ) 4 Competitive intensity will increase with multiple targeted molecules per indication The number of products in development for oncology exceeds that of any other TA By 2015 this means that there will be multiple targeted molecules per indication Estimated number of targeted therapies in 2015 Phase III Number of product in development Phase II Indications with largest pipeline Phase I Renal cell carcinoma (RCC) Oncology 366 117 Non-small cell lung cancer (NSCLC) Non-Hodgkin’s lymphoma (NHL) Breast cancer CNS 287 128 Multiple myeloma Lymphoma Prostate cancer Anti-infective 194 74 Head & neck cancers Colorectal cancer 104 70 Cardiovascular Pancreatic cancer Ovarian cancer 77 44 Melanoma Respiratory Leukaemia, acute myeloid (AML) SOURCE: Evaluate Aug 2009; Pharmaprojects

  14. 158 5 Competition to source patients for cancer clinical trials will increase I cannot fill my own HER-2 clinical trials. When Genentech asked why I couldn’t do their trials, I had to tell them that their other trials were taking away all of the patients. KOL Breast Physician • Key issues with patient recruitment • Patient participation rates are low (less than 5%) • The number of clinical trials is growing >3 times faster than incidence rates • Within indications, certain patient segments are becoming competitive as trials move towards more personalized therapies • A shortage of clinical oncologists is expected in the U.S. in the next 10 years • Emerging trends • New drugs are taking longer to reach market and are costing more, partly because of difficulties enrolling patients • Companies are performing a higher % of their clinical trials outside the U.S. • However, current initiatives by patient groups and cancer agencies to match patients with clinical trials and raise awareness of trials among physicians may increase participation In the past 10 years, cancer networks have done a good job of pulling in patients who live farther away from the centers, who would not have previously participated. KOL Ovarian Physician Everyone developing a VEGF inhibitor is scared of Avastin. They are taking up patients and blocking trials. KOL Breast Physician Sources: Physician interviews; Journal of Oncology; Drug Discovery and Development; American Society of Clinical Oncology; clinicaltrials.gov, sitetrove

  15. Merger partner rank** 1 2 5 7 4 3 12 6 Discovery – preclinical Big deals will be done to keep oncology pipelines full 6 Phase I-II Phase III – marketed Technology/other Number of oncology therapeutics deals, 2000-07 Genentech* 3 3 38 Roche 9 6 36 J&J 7 10 35 AZ 1 4 34 Amgen 7 2 32 Novartis 5 5 25 Sanofi-Aventis 7 23 Pfizer 3 4 17 * Exception to the rule with strong pathway focus and thus high early stage activity ** Out of 15, survey of 15 biotech companies Source: Windhover’s Strategic Intelligence Database; team analysis

  16. 63 Major cancers Comparison of diagnosed incident by cancer site Asia U.S. EU* 7 Significant growth from emerging markets particularly Asia…for Asia prevalent cancers Per 100,000; 2007 3 Major cancers in Asia Stomach Colorectal Lung Liver Breast Prostate * France, Germany, Italy, Spain, and U.K. Source: Decision resources patient base

  17. Competition to source patients for cancer clinical trials will increase Market access will be increasingly challenging due to cost pressures in markets 3 7 #3: Challenging pre-conceptions and delivering shared goals…..or what can Wales do?? Trends 1 The market will be hyper-competitive, with big players investing heavily in R&D 2 R&D focus will completely change, moving towards personalised medicine and molecular targeting Competitive intensity will increase with multiple targeted molecules per indication 4 5 Opportunities to in-license late stage oncology compounds will be more difficult to find due to increased demand and limited compounds- more focus on scientific partnering 6 Pharmacos will increasingly look to Asia for new markets where the prevalence of diseases such as stomach and liver cancer is higher

  18. #5 Competition to source patients for cancer clinical trials will increase • Disadvantage • Small&dispersed • 3 million population • 19,000 new patients/annum* • Advantages • Stable (Politically, economically, geographically) • Global UK Medical and Science brand • NIHR has Competitive time and target and 70day metrics • 50% cheaper than US *wales cancer intelligence and surveillance unit

  19. #5 Competition to source patients for cancer clinical trials will increase • Small: • Lever as an opportunity • (learn the lesson from New Zealand) • Clinical Trial Regulations • Undercut on cost or time or both • Create a USP eg digital patient • Dispersed: • No room for parochialism • (learn the lesson from Singapore!) • “Wales Cancer Research Centre” • 3 wards • SE Wales 1.4M • SW Wales 1M • N & Mid 0.8M 0.8M 1M 1.4M *wales cancer intelligence and surveillance unit

  20. #3 R&D focus will completely change, moving towards personalised medicine and molecular targeting + Treatment = Drug Disease • Pharma • Huge compound libraries • Lead optimisation • PK optimisation • Toxicity screening • Manufacturing & Formulation • Academia • Unmet medical need • Patient derived material • Target identification • Target validation in model systems • Predictive biomarkers ….but predictive biomarkers need to access patient derived material from drug treated patients….best collected…..in a clinical trial

  21. NHS and Industry Improving cancer outcomes: Challenging pre-conceptions and delivering shared goals Professor Andrew Hughes Chair Experimental Cancer Medicine, University of Manchester Wales Cancer Conference November 24th 2017

  22. Backups

  23. Precision Medicine Capabilities needed Interaction models Regional qualification centres Technologies for stratification Inter-sponsor agreements Multi-arm clinical studies “Niche” populations available Network working is key

  24. Patient Centricity Capabilities needed Interaction models Trial on a Smartphone IRB’s & Legal 24h clinical trial data review Software/AI; culture, regulators Patients! Chief Patient Officer

  25. Industry Academia Misconceptions Misconceptions Strengths Strengths Constrainers Constrainers

  26. 1 point of contact We’re here throughout Responding quickly Building trust Talk my language Great Science AND Great Relationships

  27. Normal Energy/ Reward level

  28. 2 Oncology is one of the fastest growing TAs, driven by unmet medical need ESTIMATE Incidence/ deaths by tumour types Thousands of patients (2005) Worldwide sales in oncology $, billions • Cancer therapies are expected to almost double from 7% to 13% of the overall drug market by 2012 • New technologies and knowledge of genomics and proteomics will drive strong growth in targeted therapies • The patient experience is likely to change, given fewer side effects associated with targeted therapies Incidence Annual growth rate 2003-15 % Deaths 113 Prostate cancer 10 12 U.S. 43 258 +12% 6 Japan 27 169 10 EU5 58 352 82 16 8 8 Breast cancer 10 16 3 U.S. 45 216 16 Japan 27 124 Immuno-modulators 40 EU5 57 268 16 3 30 Hormonal 7 23 61 Lung cancer 3 10 Cytotoxic 5 U.S. 166 196 7 33 Supportive 12 Japan 107 126 10 Targeted EU5 226 266 9 5 2003 2005 2010 2015 SOURCE: 2003-2009 from Evaluate. 2009-2015 is team estimate, based on belief that overall oncology market growth will slow slightly, driven by stagnation in hormonals and cytotoxics after key patent expirations 29

  29. Global cancer incidence 2010 - 2030 Cancer incidence by region • Significant growth in Asia driven by smoking explosion • EU/RoW - earlier detection • Low incidence Asia – present late • Japan higher incidence premenopause • Asia drives incidence growth • Earlier presentation – Japan China represents the largest & fastest growing market opportunity • Growth in incidence (30%) balanced by patient affordability restricting access to 10% of population • Market access to rise with growth in middle classes • Limited pharma investment in predominant Asian cancers (Liver & Gastric) • Business Plan forecasts refer to accessible populations only • US & EU remain key regions - driving adoption with PHC • Significant growth from Asia - increasing westernisation and ageing populations Sources: Globocan, Decision Resources, Oncology DA modeller

  30. 8 25 169 100 35 Disease prevalence The aging population in Asian markets will further increase the prevalence of cancer Stomach Liver Breast Colorectal Lung Prostate Proportion of older age population is steadily increasing in Asia, especially Japan and China This will increase the patient pool as the incidence of most cancer rises with age Millions, percent Rate per 100,000 in Japan; 2002 100% = 1,313 1,421 127 124 28 20 12 8 2005 2020 2005 2020 65+ population, million 85- 30- 34 35- 39 40- 44 45- 49 50- 54 55- 59 60- 64 65- 69 70- 74 75- 79 80- 84 Source: UN population bureau; National Institute of Population and Social Security Research; Bureau of Cnsus McKinsey analysis

  31. 8 Cancer classification will become more specific and treatments increasingly targeted ESTIMATE Management Susceptibility Projected oncology molecular testing market volume, 2006-2016 Number of tests, thousands • Tests related to cancer management are expected to see the largest growth (e.g., HER2/neu) • Susceptibility testing is only expected to see minimal growth • Areas of focus will be breast, CRC, and melanoma • Current tests are expensive and only provide and indicator of risk • A good family history is often as good an indicator of risk as susceptibility tests CAGR % 1,117 13 1,016 923 836 763 694 632 574 516 1,098 13 440 997 905 332 818 746 677 615 558 500 425 318 3 18 18 19 19 14 15 16 16 17 17 17 Projected molecular testing market size, 2006-2016 $, millions 23 2006 07 08 09 10 11 12 13 14 15 2016 SOURCE: Kalorama 2007; team analysis 32

  32. Opportunities to in-license late stage oncology compounds are more difficult to find… Oncology compounds in clinical development, 2007** Percent Unavailable for license* 100% = 742 Available for license 336 14 196 Phase III 11 210 532 86 Phase I/II 89 Biologics Small molecules * Already in-licensed ** Includes small molecules and biologics in phases I through III ; excludes preclinical and registered/marketed compounds Source: PharmaProjects

  33. Global Oncology Market - Regional Drivers • US oncology sales $10bn - 50% of the Global oncology market • share increase expected (60%; 2010) as highly priced new treatments launched and adopted first in the US • growth drivers: • increasing incidence - ageing baby boomers • changes to reimbursement practices • impending parallel import legislation increasing sensitivity to world -wide pricing policies • European market value $5bn (25%) • share declining as a consequence of cost containment pressures • increased efficacy /regulatory hurdles restrict adoption of high priced new products • increasing genericisation & parallel imports • Japanese market value $4bn (19%) • share declining due to delayed introduction of new products • increasing westernisation a key growth driver • RoW ability to pay constrains market development ($600m; 3%) Source: Oncology B&MR latest view

  34. 1 Earlier detection Disease segmentation 2 Choice or dose of treatment 3 R&D focus will completely change, moving towards personalised medicine and molecular targeting Personalized medicine Improves outcomes across three dimensions Molecular testing enables diagnosis before patient presents with phenotype, e.g., BRCA1/2 is used to identify patients at risk of developing familial breast cancer The management of a patient’s disease or disposition by using molecular knowledge (genomics, DNA modification, proteomics, and metabolomics) to achieve the best possible medical outcome for that individual Includes improved prevention, diagnosis, treatment, and monitoring across both medical research and clinical care Patients with the same diagnosis segmented according to molecular signatures for more effective therapy, e.g., HER2 testing in breast cancer to determine if patients will be sensitive to Herceptin therapy Specific drug and dose selected to minimize side-effects and maximize patient response on the basis of an individual’s molecular profile, e.g., VKORC1 and CYP2C9 test for warfarin to ensure the appropriate dose is given and potentially fatal side-effect minimized SOURCE: Team analysis 35

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