Trends in the Pharmaceutical Industry and the Potential Impact on Future Innovation and Access to Medicines Dr. Brian W Tempest www.briantempest.com Mumbai 31 July 2013 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 2005. 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 1992. 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 www.briantempest.com. 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 costs versus GDP & Wages Hale & Tempest Everybody Concerned about Health Costs Hale & Tempest Increasing Generics & Biosimilars Hale & Tempest A Slide from a UK Headhunter Hale & Tempest Pharma in Crisis Source: Pharmatimes February 2013 Hale & Tempest Generics versus Big Pharma Hale & Tempest Patent Cliff to 2018 source: Evaluate Pharma, Sandoz Hale & Tempest Top 25 Global Generic Companies Source: Generics Bulletin 10 June 2011 Hale & Tempest Rest of Top 50 Generic Companies 2012 source: Generics Bulletin June 7 2013 Hale & Tempest Products Going Off Patent in 2015 $33b Source: Evaluate Pharma 14 February 2013 Hale & Tempest The Teva Future – Standing Still Source: RBC Capital 12 December 2012 Hale & Tempest Global footprint of Watson/Actavis – excluding most of the developing world Hale & Tempest Actavis R&D Assets source: Actavis Promotional Material before Warner Chilcott acquisition Hale & Tempest Actavis Manufacturing Assets source: Actavis Promotional Material before Warner Chilcott acquisition Hale & Tempest Sandoz Sales 2012 source: Novartis, Generics Bulletin June 7 2013 Hale & Tempest Indian Generic Cos continue to grow Source: Pharmatimes World News Feb 5 2013 •Many Indian Companies in 2013 showing a sales growth of >20% •Indian Pharma Exports 2008-2012 around the World have shown a %CGR of +19% in sales • New Product Pipeline in USA ANDAs shows approvals from India in 2012 was 37% with 178 out of a total of 476 and in 2011 33% with 144 out of 431 •New ANDA filings of ANDAs in the USA from India indicate 51% in 2011 and 49% in 2010 Hale & Tempest India’s First Compulsory Licence after 3 years at a high price Source : Economic Times 13 March 2012 Hale & Tempest More CLs on the way in India Source: 29 March 2013 Hale & Tempest India 1st Patent dismissed for timing, 2nd patent for Evergreening Source: Financial Express 2 April 2013 Hale & Tempest Anti Cancer Drugs At Delhi Airport Source: New Delhi Airport 28 March 2013 Hale & Tempest But Indian Price Cuts source: Hindustan Times 20 June 2013 Hale & Tempest Aggressive EU-India Bilateral FTA Source: ET 27 March 2013 Hale & Tempest The Future of IP? •In 2012 Big pharma had the best NCE year since 1997 •There are $230b sales going off patent in 2013-2018 but only half will be replaced by generics owing to biologics •Big Pharma is finding the BRICS markets tough •More CLs likely from the BRICS countries owing to evergreening or a very high price limiting access •Do all patents need to be 20 years? The first USA patent law in 1790 was for 14 years. Amazon suggest 3-5 years. Hale & Tempest •What is the point of a patent if only the rich can use it? Thank You brian.tempest@clara.co.uk www.briantempest.com Hale & Tempest