Hale & Tempest Understanding the Strategies Big Pharma are Developing to win in the Global Generics Market Dr. Brian W Tempest Istanbul, Turkey 27 September 2011

Hale & Tempest Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade. Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until He was then Chief Mentor and Non Executive Director until 2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director Far East and Regional Director Middle East & Africa from 1985 to Brian has worked in the Pharmaceutical Industry for the last 40 years and has managed Healthcare businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan and India. He has also led many sessions at Investor Meetings held around the world. He is now Independent Chairman of Religare Capital Markets PLC and a Non Executive Director of Fortis Healthcare India with 62 hospitals and SRL the largest Indian Diagnostic Company which conducts 70,000 tests per day. Brian is an international advisor to MAPE, India and the United Nations (UNCTAD) in addition to being a member of the SCRIP Global awards panel he is on the Editorial Board of the Journal of Generic Medicines. Brian speaks at global conferences and more information on these presentations can be found on his website Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became Chairman of the Advisory Board for the Lancaster University Management School which ranks 4 th in the UK He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is now Chairman and Senior Partner of Hale & Tempest

Hale & Tempest Generic Medicines are part of the Solution for Ageing Populations

Hale & Tempest China/India with 37% population, 14% of wealth and most of the GDP growth

Hale & Tempest Exploring the Strategic Drivers - Big Pharma

Hale & Tempest Only FDA New Drug Approvals Source: Fiercebiotech 22 Jan 2011

Hale & Tempest USA DOJ Fines on Big Pharma Source: Chemistry World Jan 2011

Hale & Tempest USA Batch Recalls Source: Deutche Bank 29 March 2011

Hale & Tempest Approvals & Reimbursements Source: Pharmatimes UK August 2011

Hale & Tempest Big Pharma Losing to Local Players Source GSK Presentation

Hale & Tempest Emerging World Share of Pharma Source EIU, OECD, WHO, IMS, Roland Berger

Hale & Tempest Top 8 Cos in Emerging Markets 2008

Hale & Tempest Increasing Pace of Emerging Markets AcquisitionsEmerging Market Investor Days March 16, 2010 December 10, 2009 July 2, 2009 Large Cap Pharma Entering Generics (Egypt, Pakistan, Near East ) (MENA, LatAm, Asia-Pac) (Algeria) With the slow-down of Western markets, Pharma are rapidly repositioning to focus on emerging markets for growth

Hale & Tempest Key Big Pharma-Generics Deals

Hale & Tempest Evaluating Market Expansion - Generic Companies

Hale & Tempest Asia vs. the Western Generic Companies Source: Factset, Religare

Hale & Tempest Pricing Pressures Source: Watson

Hale & Tempest European Generic Prices Source Ranbaxy

Hale & Tempest European Generic Prices Source Ranbaxy

Hale & Tempest USA - ANDA Growing Approval Times Source FDA Chief M Hamburg, GpHA Conference February 2010  months average  months average  Around 2000 ANDAs awaiting approval  FDA explained as a result of staff shortages  Regulatory filing fees needed

Hale & Tempest Season of Warning Letters/Import Alerts Source: Deutche Bank July 2011

Hale & Tempest USA - Litigation Success Rates Source RBC Capital Markets January  Patent Challenges on rise - 65 FTFs in 2009  Success rate at 48% - or 76% including deals  3 courts hold 69% with 36% success e.g. NJ  4 courts never ruled against generics e.g. NY  At risk launches on the rise – 6 in 2009  Teva has 12 of the 28 at risk launches – 2002/9  Settlements on the rise – 54 in 2009  Teva accounts for a third of all settlements  Authorized generics on the rise – 25 in 2009  Watson represents a fifth of all AGs

Hale & Tempest Generic Profit Margin Profile in descending order source: Deutsche Bank July 2010

Hale & Tempest Top 25 Global Generic Companies Source: Generics Bulletin 10 June 2011

Hale & Tempest Next 24 Global Generic Companies Source: Generics Bulletin 10 June 2011

Hale & Tempest Patent Expiries Source: Sandoz

Hale & Tempest In 2016 Top 10 8 will be Biologic/Resp Source: Sandoz EGA Conference 2011

Hale & Tempest Leveraging the Power of Branded Generics in Receptive Markets - Indian Pharma Companies

Hale & Tempest WHO Pre Qualified Products

Hale & Tempest Indian Generic FDA ANDA Approvals

Hale & Tempest Niche Technology Source: MAPE

Hale & Tempest India – Share of CRAMS Market

Hale & Tempest Lots of Opportunity for CROs in India Source: clinicaltrials.gov 16 Feb 2011

Hale & Tempest Future Development Opportunities – Macro Strategic Changes

Hale & Tempest Pfizer & Hisun

Hale & Tempest Pharma Wholesaler sets up China JV UK Coop – the world’s largest consumer cooperative  GBP£10b UK company  running food stores, banks, insurance, funeral homes, travel agents, farms and pharmacies  3 rd rank pharmacy chain in UK with 800 stores  Owns UK pharmaceutical wholesaler Sants  Opus Marketing JV with Day Lewis Pharmacy Chain offers 113 products under Prospect brand  Tianjin Tasly Sants Manufacturing JV opened 2010, “production under way” Jun 2011  With Investment GBP£20m, 200 staff

Hale & Tempest China Pharma Industry Capex Plans Source: Stravencom

Hale & Tempest India Pharma Industry Capex Plans Source: MAPE

Hale & Tempest FDA DMFs from India

Hale & Tempest FDA DMFs from China

Hale & Tempest Chinese ANDAs

Hale & Tempest Endangered Elements Source: Chemistry World 2011

Hale & Tempest A New World Order is Coming

Hale & Tempest Thank You