2004: 39.4 (35.9 – 44.3) million Western & Central Europe [ – ] North Africa & Middle East [ – 1.5 million] Sub-Saharan Africa 25.4 million [23.4 – 28.4 million] Eastern Europe & Central Asia 1.4 million [ – 2.1 million] South & South-East Asia 7.1 million [4.4 – 10.6 million] Oceania [ – ] North America 1.0 million [ – 1.6 million] Caribbean [ – ] Latin America 1.7 million [1.3 – 2.2 million] East Asia 1.1 million [ – 1.8 million] THE GLOBAL BATTLE AGAINST THE AIDS EPIDEMIC: A GENERIC MANUFACTURERS PERSPECTIVE Source: UNAIDS – World Bank March 10 th, 2005

Scope of the global challenge Regional HIV/AIDS statistics: 2004 Global estimates for adults and children: 2004 Fact: UNAIDS estimate: 39.4mn PWA; year end % Children ; 45% Women 4.9mn newly affected in mn deaths in ,000 new HIV infections per day Worldbank; March 10 th, 2005

Elements of the solution 1)Recognition and Prevention of the Disease 2) Pharmaceutical Intervention (Antiretroviral Agents - ARVs) 3) Infrastructure for access and to medically support patient’s needs 4) Ongoing support to manage patient’s overall well-being 5) Funding Worldbank; March 10 th, 2005

Supporting Organizations PEPFAR In his 2003 State of the Union address, President Bush announced PEPFAR, a five-year, $15 billion initiative to turn the tide in combating the global HIV/AIDS pandemic. The plan is designed to complement and enhance national, provincial and local governmental HIV/AIDS activities and to strengthen private sector responses. UNAIDS The Joint United Nations Programme on HIV/AIDS, UNAIDS, is the main advocate for global action on the epidemic. It leads, strengthens and supports an expanded response aimed at preventing transmission of HIV, providing care and support, reducing the vulnerability of individuals and communities to HIV/AIDS, and alleviating the impact of the epidemic. WHO The World Health Organization is the United Nations specialized agency for health. It was established on 7 April WHO's objective, as set out in its Constitution, is the attainment by all peoples of the highest possible level of health. W.J Clinton Foundation President Clinton has made the battle against HIV/AIDS a focal point of his Foundation's activities. He believes deeply that until we combat the epidemic in the developing world, where an estimated 40 million people are infected with the disease, lives that could be spared will be lost and it will be impossible for these countries to achieve social and economic development goals. Other NGOs Worldbank, Bill & Melinda Gates Foundation. Private Sector Pharmaceutical companies: Brand and Generic Worldbank; March 10 th, 2005

“The hurdles” Formulate ARVs that are bio-equivalent to existing brands that can be manufactured in a more cost-effective manner. Generate scientific data to support bio-equivalency for review by US FDA (as per PEPFAR guidelines). Gain FDA approval and establish channels for distribution through supply chain consortiums. Manufacture product to meet the requirements of healthcare systems to support patient care. Address equivalency and quality questions. Worldbank; March 10 th, 2005

The Ranbaxy Plan Majority of 16 ARV dossiers to be submitted to the US FDA by Summer ‘05. Cooperative scientific effort required between Active Pharmaceutical Ingredient (API) supplier; Ranbaxy formulation scientist and manufacturing groups. Work with independent CRO to generate required data. Data submitted to WHO concurrently for inclusion in drug listing. Worldbank; March 10 th, 2005

The Ranbaxy Comittment “We are well aware and applaud the fact that your administration, in the interest of protecting patients, has implemented an FDA review process for all generic ARV drugs used in the PEPFAR initiative, an important measure for patient safety…………. We plan to complete our bio- equivalence studies for our entire portfolio of ARVs within the coming year. Our current plans are to manufacture all PEPFAR-approved ARVs at Ranbaxy Laboratories Ltds’ FDA inspected and certified facilities to ensure the highest quality manufacturing environment” Letter to Secretary Tommy G. Thompson US Department of Health and Human Services Brian W. Tempest. PhD. Managing Director and CEO Ranbaxy Laboratories Ltd. January 2005 Worldbank; March 10 th, 2005

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