Choosing the Licensing Strategy for Every Stage of Drug Development Dr. Brian W Tempest www.briantempest.com EU Pharma Law- Geneva Switzerland 5 November 2008

www.briantempest.com

Licensing Deals 1997-2006

Asia 2040

Indian & Chinese Strategies

The Possible Use of India & Asia in R&D Early discovery leads from USA, Europe or Singapore Molecular optimisation from India Toxicology from China, Central Europe, Singapore Electronic Data Capture India API Manufacture India Drug Formulation Manufacture India, USA Phase 1 Clinical Trials Europe Phase 2,3 heavy use of India Corporate back office India

Speed of Clinical Trials in India EU India Patients 85 650 Sites 22 5 Time 36m 18m Neck Cancer CT In 2007 Pfizer carried out 44 CTs at 143 sites in India involving 1800 patients in oncology, infectious diseases, CVS, psychiatry, respiratory and metabolic diseases . On par with China. Source Dr Mattina President R&D No. of USA investigators: 2001 2006 26,000 18,000 300 patients, 30 sites $5.6m EU/USA vs. $ 1.8m plus 30% faster at $800K per day savings Sources: CT Outsourcing Conference, 24th July 2007, Mumbai

Electronic Data Capture in India Accuracy - 300 GSK Staff - 2.2m Clinical Data sheets - 450 Trials - No data security issues - Error rate <0.01 / 100k Source: BCG report “Looking Eastward, Sept’2006” % Trials in EDC 2005 2007 25% 45% Savings Paper EDC $2.8m $ 0.5m 2004 data Sources: CT Outsourcing Conference, 24th July 2007, Mumbai

Cost of Goods in India

M&A Deal Multiples

M&A impact on Innovation

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