European Pharmaceuticals Pharmaceuticals Industry Update
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Deutsche Bank Markets Research Europe Industry Date United Kingdom 29 August 2012 Pharmaceuticals European Pharmaceuticals Pharmaceuticals Industry Update Jeremy Lai, MD Tim Race, CFA Research Analyst Research Analyst (+44) 20 754-58441 (+44) 207 54-76522 [email protected] [email protected] Pharmaceuticals for Beginners 2012 Mark Clark Research Analyst (+44) 20 754-75875 [email protected] Richard Parkes, Ph.D Research Analyst (+44) 20 754-50470 [email protected] Holger Blum, DVFA Research Analyst (+41) 44 227-3376 [email protected] ________________________________________________________________________________________________________________ Deutsche Bank AG/London All prices are those current at the end of the previous trading session unless otherwise indicated. Prices are sourced from local exchanges via Reuters, Bloomberg and other vendors. Data is sourced from Deutsche Bank and subject companies. Deutsche Bank does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. DISCLOSURES AND ANALYST CERTIFICATIONS ARE LOCATED IN APPENDIX 1. MICA(P) 072/04/2012. Deutsche Bank Markets Research Europe Industry Date United Kingdom 29 August 2012 Pharmaceuticals European Pharmaceuticals Pharmaceuticals Industry Update Jeremy Lai, MD Tim Race, CFA Research Analyst Research Analyst Pharmaceuticals for Beginners 2012 (+44) 20 754-58441 (+44) 207 54-76522 [email protected] [email protected] Welcome to the 2012 edition of Pharmaceuticals for Beginners Mark Clark So, you’ve inherited the pharmaceutical sector. Big companies, large market Research Analyst capitalisations and interesting diseases with some funny-sounding names. (+44) 20 754-75875 Fantastic! You finally get to follow a sector that might actually be of interest to [email protected] the person sitting next to you at a dinner party. But wait. What is a GLP-1 analogue, and why can’t analysts just say heart Richard Parkes, Ph.D attack or heartburn instead of using lengthy terms like myocardial infarction or Research Analyst gastro-oesophageal reflux disorder? And what on earth is a randomised, (+44) 20 754-50470 placebo-controlled, double-blind, Phase III clinical trial anyway? Oh no, what [email protected] have I gotten myself into? Holger Blum, DVFA In our view, the pharmaceutical industry is fascinating, exciting and of obvious Research Analyst relevance beyond the stock market. But it is also very technical and comprises (+41) 44 227-3376 a minefield of products, scientific terms and disease pathways. Keeping track [email protected] of it all can at times prove bewildering, and not just for the uninitiated. With this in mind, the pharmaceuticals team at Deutsche Bank first published a document in January 2001 that was targeted at beginners and industry veterans alike – “Pharmaceuticals for Beginners”. The first and subsequent editions were such a success that we are now publishing our 2012 edition, which has been completely updated, while retaining much influence from the original. This report is structured in two parts, with the first providing an introduction to the industry dynamics and regulatory framework governing pharmaceuticals, and the second containing an introduction to the different therapeutic markets. The current edition covers 32 disease areas, including new topics such as Pulmonary Arterial Hypertension and Epilepsy. We have also included overviews on topics such as emerging markets, vaccines, orphan genetic diseases, consumer health and animal health. “Pharmaceuticals for Beginners” is not necessarily intended to be read cover to cover, but is meant as an easy-to-use reference guide. Although our intent was to provide professionals who are new to the pharmaceuticals sector with an introduction to a complex industry, we hope that our more learned readers will find new insights as well. Overall, we hope that this book will be a valuable resource that might find its own spot on many overcrowded desks. ________________________________________________________________________________________________________________ Deutsche Bank AG/London All prices are those current at the end of the previous trading session unless otherwise indicated. Prices are sourced from local exchanges via Reuters, Bloomberg and other vendors. Data is sourced from Deutsche Bank and subject companies. Deutsche Bank does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. DISCLOSURES AND ANALYST CERTIFICATIONS ARE LOCATED IN APPENDIX 1. MICA(P) 072/04/2012. 29 August 2012 Pharmaceuticals European Pharmaceuticals Industry Overview Introduction .................................................................................... 5 The companies ............................................................................. 14 Leading drugs ............................................................................... 24 Research ....................................................................................... 29 Research glossary ........................................................................ 36 Genomics and biotechnology ....................................................... 37 Regulation .................................................................................... 43 Funding and pricing of pharmaceuticals ...................................... 51 Generic drugs ............................................................................... 69 Patents and market exclusivity ..................................................... 74 Biosimilars .................................................................................... 80 US patent litigation ....................................................................... 84 US legislative process .................................................................. 90 Legislative dictionary .................................................................... 94 Pharmaceutical marketing............................................................ 97 Emerging markets ...................................................................... 105 Consumer healthcare ................................................................. 119 Animal health ............................................................................. 122 Vaccines ..................................................................................... 126 Companion diagnostics .............................................................. 131 Page 2 Deutsche Bank AG/London 29 August 2012 Pharmaceuticals European Pharmaceuticals Therapeutic review Introduction to cardiovascular disorders .................................... 139 Hyperlipidaemia.......................................................................... 140 Thrombosis ................................................................................. 146 Hypertension .............................................................................. 153 Pulmonary arterial hypertension ................................................ 158 Diabetes mellitus ........................................................................ 163 Erectile dysfunction .................................................................... 174 GERD and peptic ulcer disease .................................................. 177 Asthma ....................................................................................... 181 Chronic obstructive pulmonary disorder .................................... 188 Allergic rhinitis ............................................................................ 194 Osteoporosis............................................................................... 198 Pain ............................................................................................. 203 Rheumatoid arthritis ................................................................... 207 Transplantation and immunosuppression .................................. 212 Antibiotics .................................................................................. 218 Human immunodeficiency virus (HIV)........................................ 224 Viral hepatitis .............................................................................. 231 Influenza ..................................................................................... 237 Introduction to CNS disorders .................................................... 240 Schizophrenia ............................................................................. 242 Parkinson’s disease .................................................................... 248 Alzheimer’s disease .................................................................... 252 Depression and affective disorders ............................................ 256 Attention deficit hyperactivity disorder (ADHD) ......................... 260 Multiple sclerosis ........................................................................ 264 Epilepsy ...................................................................................... 270 Migraine ....................................................................................