2015 CMR INTERNATIONAL PHARMACEUTICAL R&D EXECUTIVE SUMMARY

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1 2015 CMR INTERNATIONAL PHARMACEUTICAL R&D EXECUTIVE SUMMARY AUGUST 2015

2 2 CMR FACTBOOK 2015 EXECUTIVE SUMMARY INTRODUCTION R&D productivity across the global biopharmaceutical industry is a well-documented and much discussed topic; with many industry commentators quantifying a declining R&D productivity trend in a number of ways. For example, some analysts have stratified the industry into an Era of Abundance (pre-2005) and an Era of Scarcity (post-2005); demonstrating a 70% decline in R&D productivity as measured by fifth year product sales per billion dollars R&D expenditure in recent years 1. Yet despite these analyses, there have been a number of indicators in the last twelve months which paint a more positive story. For example, the number of NME approvals by the FDA is the highest in over a decade 2. Figure 1 illustrates the trend in FDA approvals over time; highlighting that in 2014, with 41 approvals, the biopharmaceutical industry achieved the highest number of approvals in over a decade. Additionally, 44 NDA and BLA applications were submitted to the FDA throughout 2014 suggesting an overall approval rate of 93%, so perhaps, as measured by the number of FDA NME approvals at least, it seems like R&D productivity is on the rise. FIGURE 1 NUMBER OF FDA NME AND BLA APPROVALS, 2005 TO Number of FDA NDA and BLA approvals Year Source: fda.gov Key metrics identified in the 2015 CMR International Pharmaceutical Factbook indicate more positive trends emerging across the pharmaceutical industry including: The highest number of New Molecular Entity first-world launches in the last decade registered in Global pharmaceutical sales crossed the $1 trillion mark for the first time by the end of 2014 A decline in the early development pipeline coupled with a growth in the late development pipeline and success rates suggestive of the industry s ability to fail fast, fail cheaply

3 CMR FACTBOOK 2015 EXECUTIVE SUMMARY 3 NEW MOLECULAR ENTITIES FIRST-WORLD LAUNCHES Expanding beyond the US, Figure 2 illustrates biopharmaceutical R&D output through a different metric; by counting the number of New Molecular Entities (NME) first-world launches in the global market over time. This analysis illustrates an equally positive message as compared to the data in Figure 1, with 46 firstworld launches in 2014; the highest in over a decade. However, despite the similarity in messages for 2014 across Figure 1 and Figure 2, there are a number of differences which may seem somewhat conflicting at first glance. These differences can be rationalised by considering the three main points below: A number of 2014 FDA approvals have launched previously in other countries. For example Dapagliflozin (Farxiga ) was approved by the FDA in January 2014 but first launched in the UK in November 2012 under the brand name Forxiga. Therefore, Dapagliflozin appears in the 2014 FDA approvals but in the 2012 CMR first-world launches. A number of FDA approvals were not launched by the end of 2014 and therefore whilst these are included in Figure 1 they are excluded from Figure 2. For example, Naloxegol (Movantik ) was approved by the FDA in September 2014 but was not launched until March 2015 in the US and EU. Differences in NME definitions. Amongst other aspects, the FDA includes peglyated forms of drugs and common radiopharmaceuticals in its NME definition whereas the CMR definition does not classify these types of drugs and radiopharmaceuticals as NMEs. For example Peginterferon beta-1a (Plegridy ) is included in the FDA 2014 NME approvals but excluded from the CMR NME first launches as it is a peglyated form of interferon beta-1 already launched by Biogen. FIGURE 2 NUMBER OF NME FIRST-WORLD LAUNCHES, 2005 TO Number of NMEs Year of first launch Source: 2015 CMR International Pharmaceutical R&D Factbook Examining the nature of the launches also provides an encouraging picture for the industry: One third of all launches were for rare indications. 67% of the first launches were specialty drugs indicated for the treatment of diseases such as cancer, HCV and eye disorders. Eleven NMEs were indicated within oncology of which seven received orphan drug status.

4 4 CMR FACTBOOK 2015 EXECUTIVE SUMMARY GLOBAL PHARMACEUTICAL SALES Moving on to biopharmaceutical sales, Figure 3 depicts global biopharmaceutical sales by year in addition to the corresponding annual percentage change in sales. These data illustrate two very positive messages for the industry: In 2014, global pharmaceutical sales crossed the $1 trillion mark for the first time. Sales growth above the 3% minimum which has been experienced over the past few years. FIGURE 3 GLOBAL PHARMACEUTICAL SALES, 2005 TO % Global pharmaceutical sales (US$ bn) % 12% 10% 8% 6% 4% 2% Annual change in sales Year 0% Source: 2015 CMR International Pharmaceutical R&D Factbook So, as with measuring biopharmaceutical R&D output by launches, reviewing global sales also illustrates a positive message for the industry as a whole. However, according to the 2015 CMR International Pharmaceutical Factbook only approximately 5% of global biopharmaceutical sales were derived from products launched onto the market in the preceding five years and the rest of the sales were derived from established products. These trends including the impact of generic activity on established products are further explored in the 2015 CMR International Pharmaceutical Factbook.

5 CMR FACTBOOK 2015 EXECUTIVE SUMMARY 5 ATTRITION AND SUCCESS RATE Across the industry there has been a decline in pipeline volumes in the early phases and a growth in the pipeline volumes in the late phases. Morover, the number of terminated projects in Phase III are declining as well as a stable success rate is observed for the submission phase 3. Combining these observations together actually paints a more positive picture for the industry as some encouraging conclusions may be drawn: The decline in early development pipelines coupled with a declining number of terminated projects in Phase III means the industry is improving its ability to fail fast, fail cheaply thereby progressing compounds which are more likely to succeed in later phases. The increasing focus into areas of unmet medical need and speciality care coupled with improving late phase success rates data means these types of strategies may be proving to be successful across development. FIGURE 4 PROBABILITY OF SUCCESS TO MARKET FOR ACTIVE SUBSTANCES 3 100% 90% 91% Probability of success 80% 70% 60% 50% 40% 30% 20% 10% 5% 7% 17% 65% 0% 'First toxicity 'First human 'First patient 'First pivotal 'First submission' to market Probabilities of success to market were calculated using success rates between phase for active substances entering phase between 2008 and 2010 and year of assessment Source: 2015 CMR International Pharmaceutical R&D Factbook

6 6 CMR FACTBOOK 2015 EXECUTIVE SUMMARY CONCLUSION The data presented in this executive summary highlights an industry that demonstrates an ability to respond successfully to various challenges to improve R&D productivity overall. The 2015 CMR International Pharmaceutical R&D Factbook contains metrics and analyses on R&D productivity and many other key topics relevant to the biopharmaceutical industry, such as R&D resources and pipelines, patents and generic drugs. For a full list of figures or additional information, please visit our website cmr.thomsonreuters.com or contact us using the information below. REFERENCES 1. Beyond the shadow of a drought CMR International Pharmaceutical R&D Factbook

7 ABOUT THOMSON REUTERS Thomson Reuters is the world s leading source of intelligent information for businesses and professionals. We combine industry expertise with innovative technology to deliver critical information to leading decision makers in the financial and risk, legal, tax and accounting, intellectual property and science and media markets, powered by the world s most trusted news organization. With headquarters in New York and major operations in London and Eagan, Minnesota, Thomson Reuters employs approximately 60,000 people and operates in over 100 countries. For more information, go to thomsonreuters.com. To find out more, go to ip-science.thomsonreuters.com. CMR CONTACTS Phil Miller Senior Director, Clinical & Regulatory Jasmin Mehta Clinical Practice Consultant The Johnson Building 77 Hatton Garden London EC1N 8JS T +44 (0) F +44 (0) S Copyright 2015 Thomson Reuters

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