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Market Approaches for Innovation and Access Clifford Samuel Vice President, International Access Operations  Gilead Sciences June 9, 2011
About Gilead Sciences ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Innovation Over a Decade 1 9 9 6 2 0 0 6
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®
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
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
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
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
There Is A Lot More To Do… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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 "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                                    
Establish Value Added Services to Support HSS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Stakeholders Value Added Services
Examples of Value Added Services Patient Education Materials Mobile Phone Technology Forecasting Tool Viral Load Testing Flipcharts Posters Patient Videos
Ongoing Commitment to Access ,[object Object],[object Object],[object Object],[object Object]
  Advancing Therapeutics. Improving Lives. Thank you.

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Market Approaches for Innovation and Access

  • 1. Market Approaches for Innovation and Access Clifford Samuel Vice President, International Access Operations Gilead Sciences June 9, 2011
  • 2.
  • 3. Innovation Over a Decade 1 9 9 6 2 0 0 6
  • 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. 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. 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. 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. 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.
  • 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 "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.
  • 12. Examples of Value Added Services Patient Education Materials Mobile Phone Technology Forecasting Tool Viral Load Testing Flipcharts Posters Patient Videos
  • 13.
  • 14. Advancing Therapeutics. Improving Lives. Thank you.