Hale & Tempest The Sustainability of the Generics Industry – rethinking the future Dr. Brian W Tempest World Generics Congress, London, UK 29 February 2012

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 41 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, a Non Executive Director of Fortis Healthcare the leading Asian Healthcare Company, a Non Executive Director of SRL the largest Indian Diagnostic Company and a Non Executive Director of Glenmark Pharmaceuticals. He is a member of the SCRIP Global awards panel and 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, 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 Co Ltd

Hale & Tempest Healthcare Pressures Forever

Hale & Tempest Healthcare will explode further in Asia

Hale & Tempest Consolidation in Generics

Hale & Tempest Structural Changes - Big Pharma

Hale & Tempest Fewer New Molecules Approved

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

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

Hale & Tempest US 2010 False Claims Fines Chemistry World Jan False Claims Fines - Pfizer $2.3b, Lilly $1.4b, J&J $1.b

Hale & Tempest Top Five US Industries for layoffs in 09/10 Source Challenger, Gray & Christmas

Hale & Tempest Merck – No 1 Layoffs in 2011 source FiercePharma

Hale & Tempest Big Pharma Strategies  Share repurchase - AZ, Pfizer, Sanofi Aventis  Shedding businesses – Pfizer $1.9b nutrition, $3.6b animal health, £2.4b Capsugel  Eye Care - Novartis & Alcon  Consumer Healthcare – Sanofi Aventis, GSK  OTC – P&G with Teva  DPI Inhaler – Pfizer & Mylan  Generics – Pfizer, Sanofi Aventis, AZ  Pharmemerging – GSK, Abbott, Daichi Sankyo

Hale & Tempest M&A Deals in Pharmemerging Markets Source: Company Filings, Mape Securities

Hale & Tempest Structural Changes - Generic Companies

Hale & Tempest Pricing Pressures Source: Watson

Hale & Tempest Mylan won’t follow “irrational behavior” Source : Generics Bulletin 5 August 2011

Hale & Tempest India Pharma Stock has consistently outperformed Global Peers Bloomberg

Hale & Tempest Emerging Market Equities in last 12m Source: 30 Jan 2012 Business Standard

Hale & Tempest Rising Competition Source: JM Financials 24 August 2011, Deutche Bank 8 July 2011  With generic Lotrel higher strengths there was an unexpected excessive number of generics approved after the exclusive period ended  Increased competitive activity with para 4 filings. Multiple players for small opportunities.  Small new Indian players in para 4 - Macleods for Lipitor, Hetero for Nexium

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 USA Generics Filings Source: Deutsche bank July 2010

Hale & Tempest Pending ANDAs source: Deutsche Bank Jan 2012

Hale & Tempest US Litigation Risks are Substantial  Patent Challenges on rise - 65 FTFs in 2009  Generic success rate at 48% (76% with 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 Source RBC Capital Markets January  Recent At Risk launch damages include – Apotex $0.3b, Sun $0.9b, Teva $1b+ Famvir  Teva rethinking At Risk strategy

Hale & Tempest China Pharma Industry Capex Plans Source: Stravencom

Hale & Tempest India Pharma Industry Capex Plans Source: MAPE

Hale & Tempest FDA DMFs from China 3Q 2011

Hale & Tempest Indian Companies Changing Hands Source Mint Research December

Hale & Tempest Frost & Sullivan forecast the Global Generic Market at $231b in 2017 FiercePharma

Hale & Tempest 70% of Top products will be Biologic-2016 Source: Sandoz EGA Conference 2011

Hale & Tempest Biosimilar Patent Expiries $17b in 2015 Source: Sandoz

Hale & Tempest Biosimilar Patent Expires $64b in 2015 Source: IMS

Hale & Tempest Number of mABs entering the clinic annually rose to 54 in 2008 Source: Tufts

Hale & Tempest How much is a Biosimilar worth? Source: Datamonitor

Hale & Tempest Recent Biosimilar Deals  Cipla & Biomab, China $165m 12 products  Richter & Stada – mABs  Celltrion, Korea & Hospira, Egis, Hikma, BB  Biocon & Mylan, USA  Teva & Lonza, EU  Biocon Idec & Samsung, Japan  Watson & Amgen, USA  Fuji Film & Kyowa Hakko Kirin  Baxter & Momenta, USA  Actavis & Bioton,Poland  Pfizer & Hisun, China

Hale & Tempest A New World Order in Generics is Coming

Hale & Tempest Thank You