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1 1 Drug Discovery & Development for the World Market from India: How Real GV Prasad Vice Chairman & CEO, Dr. Reddy’s Laboratories 1 NOV 2007

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Indian Pharma Industry: Poised for Transformation

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Source: Capex of Top 15 companies; Annual reports, Analyst reports CAPEX BY INDIAN COMPANIES SHARE OF THE GLOBAL GENERICS PIE ANDA FILINGS FROM INDIA DMF FILINGS FROM INDIA Source: Annual reports, Analyst reports Source: USFDA website Source: International revenues of 13 Indian companies; Annual reports, Analyst/Industry reports Indian Pharma Industry BackdropIndian Pharma to dominate Global generic industry

Indian Pharma Industry BackdropHome Market also Poised for Transformation!! : 

Indian Pharma Industry BackdropHome Market also Poised for Transformation!! Growth in disposable incomes & the number of middle-class households Expansion of medical infrastructure Greater penetration of health insurance Rising prevalence of chronic diseases Adoption of product patents Aggressive market penetration Debut of organized retail chains RETAIL PHARMACEUTICAL MARKET IN INDIA US $ billion Source: India Pharma 2015, McKinsey & Co

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Innovation: Opportunity for India

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Innovation Capacity  Unmet Needs

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Innovation Capacity  Unmet NeedsWhy Is It Important? 4% Though the R&D spend is increasing, success is decreasing 1980 1985 1990 1995 2000 ‘02 ‘03

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1980 1985 1990 1995 2000 ‘02 ‘03 Innovation Capacity  Unmet NeedsWhy Is It Important? 4% Though the R&D spend is increasing, success is decreasing

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1980 1985 1990 1995 2000 ‘02 ‘03 Innovation Capacity  Unmet NeedsWhy Is It Important? 4% Though the R&D spend is increasing, success is decreasing

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Innovation Capacity  Unmet NeedsIndia’s Cost Structure… Key Advantage Western companies able to obtain a step down of 30-40% in cost by a mere site transfer to India Companies in India able to reduce the upfront capital cost of setting up a project by 25-50% Outsourced services to India significantly reduces the cost and time of clinical trials India’s huge resource of skilled scientists, available at a fraction of the cost in developed countries Scientists of Indian origin retuning provide a strong talent pool Cost Leadership (in High Risk Game) Source: IBEF, E&Y Analysis

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Improving R&D productivity, a high priority for innovator pharma companies Exploring opportunities for expanding pipeline while addressing costs as well Testing the waters: Outsourcing of non-core activities on an experimental basis Expanding partnerships: Drug discovery experimental programs in various countries Indian companies are setting up internal drug discovery programs as well as exploring partnerships with large & medium innovator companies Global Pharma’s Challenge…Creating Opportunities for Indian Pharmacos

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Innovation in India: Current Status

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Current status of Discovery & Development in India Dr. Reddy’s Glenmark Ranbaxy Cadila Torrent Sun Pharma Biocon Wockhardt Nicholas Piramal Internal Programs Aurigene, Advinus, GVK Lifesciences Dr. Reddy’s, Discman, Nicholas, Jubilant, Shasun, Divis, Suven GVK Bio, Vimta, Lambda, Lotus, Accutest Siro Clinpharm, iGate Clinical Research, Asian Clinical Quintiles, ClinTec Services Model Drug Discovery AstraZeneca Altana Clinical trials & data management Pfizer Eli Lilly Novartis GSK MNC Outposts GSK – Ranbaxy Eli Lilly – Jubilant, Suven Zydus – BI, Onconova, Dr. Reddy’s – Rheoscience, Argenta, ClinTec Aurigene – Merck/ Serono, Forest Labs, Rheoscience Merck & Co. – Advinus Therapeutics AstraZeneca – Torrent Wyeth – GVK Nicholas – Morvus, Connexios, Biosynth Syngene - Innate Partnerships Source: Company news, industry reports

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Headlines Today More than three-quarters of the Top 50 pharma companies conduct clinical development in India(1) Outsourced manufacturing activity in India at $100 million(2) Outsourced clinical trial activity in India at $75 million in 2005(3) 40 – 50 NCEs under development by Indian pharma companies (1,2) Motilal Oswal Report (3) Frost & Sullivan When will the first indigenously developed drug be launched from India?

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NCE Pipeline of Indian Companies What would be the timeframe when innovative product from India will hit the market Source: Analyst reports, company presentations At least 3-4 years away from launch

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NCE Programs focused on Metabolic Disorders Source: Analyst reports

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Building a sustainable Innovation-led business : Key Challenges

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Key Challenges Target Selection : Precedent targets vs Unprecedented targets Translatability of in vivo disease models to humans Length and Cost of meaningful human proof of concept studies Increasingly crowded research makes selection of clinically differentiated products difficult

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Key Challenges Challenges operating out of India Not yet part of the innovation eco system of venture capital, academic research & biotech Lack of talent in critical functions Access to thought leadership Funding P&L driven valuation Lack of “patient” capital Regulatory Frameworks for timely approvals Regulatory frameworks/expertise not in place Pace of approvals not satisfactory

Closing Thoughts… : 

Closing Thoughts… “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered that, the larger they have been.” -- George W. Merck Indian Pharmaceutical Industry has the potential to… Bring Affordability and Accessibility of Drugs to the Masses Increase Global Pharma Industry’s Innovation Capacity to Meet Unmet Needs But needs to get the basics right

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