Market Approaches for Innovation and Access


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The Gilead Sciences Presentation during the session "Market Interventions for Innovation and Access", UN High Level Meeting on HIV/AIDS
New York, 9 June 2011

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Market Approaches for Innovation and Access

  1. 1. Market Approaches for Innovation and Access Clifford Samuel Vice President, International Access Operations Gilead Sciences June 9, 2011
  2. 2. About Gilead Sciences <ul><li>Research-based biopharmaceutical company </li></ul><ul><ul><li>Dedicated to advancing therapeutics for treatment of life-threatening diseases </li></ul></ul><ul><li>13 marketed drugs; active R&D program </li></ul><ul><ul><li>Primary therapeutic areas: HIV/AIDS, liver disease, serious cardiovascular and respiratory conditions </li></ul></ul><ul><li>Committed to ensuring global access </li></ul><ul><ul><li>Believe our responsibility to patients extends beyond the lab and developed world markets </li></ul></ul>
  3. 3. Innovation Over a Decade 1 9 9 6 2 0 0 6
  4. 4. Gilead HIV Therapies Viread Tenofovir (TDF; 2001) Truvada® (FTC+TDF; 2004) ATRIPLA® (EFV+FTC+TDF; 2006) Emtriva Emtricitabine (FTC; 2003) Elvitegravir (EVG:integrase inhibitor) “ Quad” (EVG+GS 9350+FTC+TDF) Cobicistat/GS9350 (novel PK enhancer) In the pipeline Current Therapies Single Agents Fixed Dose Combinations/Single Tablet Regimen Truvada/Rilpivirine (TMC278+FTC+TDF) Truvada® Truvada® Truvada®
  5. 5. The Global HIV Epidemic More than 33 million estimated to be living with HIV… … nearly 95% in the developing world Source: UNAIDS. Report on the Global AIDS Epidemic. November 2010. Western & Central Europe 820,000 Middle East & North Africa 460,000 Sub-Saharan Africa 22.5 million Eastern Europe & Central Asia 1.4 million South & South-East Asia 4.1 million Oceania 57,000 North America 1.5 million Latin America 1.4 million East Asia 770,000 Caribbean 240,000
  6. 6. Challenges in Ensuring Access Delays in regulatory approval Lack of political commitment and legal structure Government taxes/duties Limited healthcare infrastructure, including diagnostics Shortage of trained healthcare workers Limited distribution networks Forecasting demand & ensuring supply Pricing of ARVs Treatment-related costs to the patient Global economic downturn
  7. 7. Gilead Access Program Model Generic Licenses Gilead Sciences International Access Operations Country-by-country product registration Value Added Services including Medical education Forecasting and reliable supply of Gilead brands 130 Countries (106 countries with No-Profit pricing), 11 Distribution Partners 95 Countries covering 82% of global HIV prevalence No price controls 5% royalty on finished product sales; API is royalty free 13 Indian, 1 South African generic licensees
  8. 8. Impact of Gilead Access Program 30,000 133,000 413,000 703,000 1,400,000 2,000,000 3,000,000 4,000,000 5,200,000 6,600,000 Viread/TDF All ARVs 2% 4% 10% 14% 21% Gilead Partners Patients 2006 2007 2008 2009 2010 $17 $12.42 $12.42 $8.25  = 36% Viread/generic TDF $6.15  = 36%  = 58%  = 69%*  = Difference between partner and Gilead price (includes distributor markup) Price Registrations 21 45 71 82 Viread registrations Partner tentative FDA approvals/ WHO prequalifications 1 4 12 19 38 67 78 Truvada registrations 93* 19 90* * As of April 2011
  9. 9. There Is A Lot More To Do… <ul><li>HIV </li></ul><ul><li>“ Tip of the iceberg” </li></ul><ul><li>~1.4 Million patients on tenofovir </li></ul><ul><li>“ Below the water” </li></ul><ul><li>~13 Million patients 1 </li></ul><ul><ul><li>~ 5 Million on d4T and AZT </li></ul></ul><ul><ul><li>~ 9 Million untreated </li></ul></ul><ul><li>With new WHO guidelines of treating with CD4 < 350 </li></ul><ul><li>Global prevalence of chronic HBV </li></ul>
  10. 10. Stakeholders Recognize Importance of Healthcare Systems Strengthening (HSS) “ [The greatest challenge was]…Significantly improving and strengthening our health system – building and expanding our health infrastructure, rapidly scaling up our health workforce and revamping our information systems. We want to achieve universal access to primary health services of an acceptable standard to all Ethiopians.” Dr Tedros Adhanom Ghebreyesus , Health Minister, Ethiopia &quot;As long as people lack adequate education and health care, infrastructure, access to land, capital, finance and market institutions, they simply cannot take advantage of growth. They are trapped in a vicious cycle of poverty,” President Jacob Zuma of South Africa Creating sustainable measures in the war against diseases “ There is an urgent need for the developed nations to facilitate creation of sustainable measures in the war against killer diseases such malaria, tuberculosis and HIV/AIDS and that the appropriate and sustainable methods of tackling the leading killer diseases would be to create capacity for local drug manufacturers through technology transfer.” President Mwai Kibaki of Kenya                                    
  11. 11. Establish Value Added Services to Support HSS <ul><li>Skills Training </li></ul><ul><ul><li>HIV AIDS Treatment and Management Training </li></ul></ul><ul><ul><li>Nurse Prescribing and ARV Treatment Training </li></ul></ul><ul><ul><li>Training to Support Resistance, Failure and Long Term Side Effects Management </li></ul></ul><ul><li>Knowledge and Awareness building </li></ul><ul><ul><li>Product Based Medical Education </li></ul></ul><ul><ul><li>Provision of Innovative Patient Education Materials and Modalities </li></ul></ul><ul><li>Monitoring Compliance </li></ul><ul><ul><li>Strengthening Pharmacovigilance Systems </li></ul></ul><ul><li>Distribution </li></ul><ul><ul><li>Quality Forecasting and Planning Support </li></ul></ul><ul><ul><li>Targeted Essential Equipment, Technologies or Supplies Support </li></ul></ul><ul><li>Physicians </li></ul><ul><li>Nurses </li></ul><ul><li>Pharmacist </li></ul><ul><li>Community Healthcare Workers </li></ul><ul><li>Patients </li></ul><ul><li>Ministry of Health, Finance </li></ul><ul><li>Procurement agents </li></ul>Stakeholders Value Added Services
  12. 12. Examples of Value Added Services Patient Education Materials Mobile Phone Technology Forecasting Tool Viral Load Testing Flipcharts Posters Patient Videos
  13. 13. Ongoing Commitment to Access <ul><li>2011 Gilead goal: Reach 3 million HIV patients in developing countries with the company’s medicines </li></ul><ul><ul><li>Continue strengthening distributor and licensing models </li></ul></ul><ul><li>Progress discussions with Medicines Patent Pool </li></ul><ul><li>Provide AmBisome ® for visceral leishmaniasis and HIV related opportunistic infections </li></ul>
  14. 14. Advancing Therapeutics. Improving Lives. Thank you.