1. Quelles sont les responsabilités d’une grande firme pharmaceutique dans l’accès aux ARV dans les pays a faible ressource? Jim Rooney, MD VP Medical Affairs Gilead Sciences Rencontres Nord-Sud IMEA Meeting Dec 6 2006

2. 2 The Global Impact of HIV Over 40 million people are infected with HIV, and over 90% live in resource limited settings New HIV treatment programs are scaling up in the “Pays du Sud” and are making life saving HIV medications available to many thousands of patients in need It is critical that the HIV drugs available in the US and Europe be made available for treatment of patients in resource limited settings

3. Update From the 2006 International AIDS Conference North Africa and Middle East 440,000 Sub-Saharan Africa 24.5 million Eastern Europe and Central Asia Central Asia 1.4 million 1.4 million Oceania78,000 North America 1.3 million Caribbean330,000 Southern and Southest Asia 7.6 million Latin America 1.6 million UNAIDS, 2006. Available at: http://www.unaids.org. Western/ Central Europe 720,000 Adults and Children Estimated to Be Living With HIV, 2005 East Asia 680,000

4. 4 What are the obstacles to access? Infrastructure- inadequate facilities and a shortage of trained healthcare professionals Regulatory hurdles; it takes significant time for review and drug approval, and approval processes are not harmonized Fees, tariffs, value added taxes New drugs take time to be added to treatment guidelines Distribution can be challenging Cost of drugs Complexity of treatment and side effects

5. 5 What can companies do to improve access? Some of the things that companies can do to help facilitate access include 1. reduce the cost of manufacturing and lower costs of drug 2. strengthen the distribution network 3.Work with regulatory agencies, WHO, Global Fund and PEPFAR towards the goal of regulatory harmonization and standardization 4.Work with non profit organization to facilitate access 5.Invest in research 6.Invest in infrastructure and training

6. 6 What can companies do to facilitate access? 1.Reducing Manufacturing Costs – Improvements in the manufacturing process and economies of scale –Partner with local companies and generic pharma to provide competition to lower prices 2.Strengthen the distribution network –Work with local distributors –Partner with other companies with an established distribution network and knowledge 3.Regulatory harmonization –Standardized submission dossier and review process –Facilitate granting of import waivers

7. Gilead/Generics Pharma Partnership Aspen:  Manufactures finished product according to U.S. GMP standards for all Access Program countries  Distributes products under their global trade names in every country in Africa  Pursues regulatory approval for the products in African countries where one or both products are not already registered Gilead:  Transfers the necessary technology for the products  Scientific collaboration Others agreements: 1.Alkem Laboratories, 2.Aurobindo Pharma, 3.Emcure Pharmaceuticals, 4.FDC, 5.Hetero Drugs Ltd., 6.J.B. Chemicals, 7.Matrix, 8.Medchem, 9.Ranbaxy, 10.Shasun 11.Strides Arcolab

8. 8 Invest in Research Local Research –Research to determine how HIV drugs work in specifics populations and settings –Support both treatment and prevention research –It is very important that companies (including generics) participate in, and support, this type of research Invest in new drug development –Simplify therapy –More potent agents –Less side effects –Active against different virus strains and resistant

9. 9 An Example of Commitment to Research Gilead made a commitment to make their HIV drugs (Viread, Emtriva, and Truvada) available for treatment and prevention research in resource poor settings Gilead has committed > 50,000 pt/yrs of drug to this research effort representing tens of million dollars worth of drug Currently involved in more than 20 studies which will enroll > 10,000 patients in Asia, Africa, and Latin America

10. 10 Collaborative Treatment Studies Ongoing Examples NameDescription# pts planned# enrolled ACTG5175ART naive15201108 5208Nev exposed women 640206 5221HIV/TB coinfection 8002 MRCDARTNaïve/ lab testing30003315 ANRSSenegalNaive40 ANRSTemAAPregnancy602 Swiss/ Thai StaccatoNaïve/STI400411

11. 11 Senegal - ANRS 1207 Single arm pilot study of TDF+FTC+EFV 40 treatment naïve pts with CD4< 350 cells/mm 3 Baseline HIV RNA 5.3 log 10 and CD4 122 cells/mm 3 At wk 48: –85% of pts had HIV RNA < 400 copies/mL –72% had HIV RNA < 50 copies/mL –CD4 cell increase from baseline of 185 cells/mm 3 Good adherence and safety profile

12. 12 Research on Prevention Most experts agree that scale up of HIV treatment programs is not sustainable without substantial improvements in prevention New strategies for prevention involving HIV drugs include –Prevention of transmission from mother to child (PMTCT) –Pre-Exposure Prophylaxis –Microbicides

13. 13 Invest in infrastructure and training Support the development of new clinics and laboratories and personnel training programs –Pfizer with the Academic Alliance in Uganda –Bristol Meyers- Secure the Future  Botswana, Lesotho and Swaziland –Merck-Botswana-Gates –Gilead  Uganda Cares  IMEA

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16. 16 Picture of Uganda Cares

17. Merci