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New Approaches to Pharma Research and Development: Evolving strategies to rejuvenate Research and Development efficiency

With industry consolidation, the economic downturn, and an increasing threat from generics, pharma companies are coming under greater pressure to fill their pipelines with innovative drugs. However, despite the costs and risks involved in drug development, the pharma industry is finding new ways to streamline the R&D process in an effort to increase efficiency and output.

Overview of ongoing trends affecting R&D and how these will shape Pharma in the future

R&D Insight from Big Pharma industry executives

Analysis into Pharma's evolving R&D portfolio between 2006 and 2009, in addition to examination of pipeline M&A and collaborative deals

Case studies of innovative strategies used to maximize R&D productivity

GlaxoSmithKline, Pfizer and AstraZeneca have the largest preclinical and clinical drug pipelines, each with approximately 200 candidates in development as of March 2009. In terms of volume growth Genentech's pipeline grew the most in terms of percentage points, almost doubling (up 95%).

Over the period 2006-09, the average growth per therapy area was 9.4%. In terms of percentage points, the therapy area experiencing the largest growth in pipeline candidates was ophthalmology, while cardiovascular pipelines saw the largest decline, indicative of Pharma's shift towards niche markets and personalized medicines.

The number of pipeline deals made during 200608 have steadily declined. However, with Biotech finding it hard to fund R&D at present, and with many companies going bankrupt, this will affect Big Pharma in the longer term, which is increasingly downsizing internal research becoming ever reliant on external sources.

Identify R&D trends in today's pharmaceutical market, and how these affect productivity and return on investment

Understand how a diverse range of strategies can improve R&D productivity and output, and identify how these can best be implemented

Gain insight into how to optimize R&D processes and increase the chance of clinical, and ultimately commercial success

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY 4

• Scope of the report 4
• Methodology for primary and secondary research 4
• Primary research 4
• Secondary research 5
• Key findings 6

CHAPTER 2 OVERVIEW OF TODAY'S R&D LANDSCAPE 11

• Current barriers to R&D optimization 12
• How are pharma companies improving R&D? 16
• Rivals move to collaborate on R&D 18
• Enlight Biosciences: a partnership dedicated to technological innovation in R&D 19
• Companies must be careful not to stifle innovation through M&A 20
• Two key types of restructuring are available to Pharma 20
• Refocusing R&D onto biologics will increase efficiency 23

CHAPTER 3 ANALYSIS OF MEDTRACK PIPELINE AND DEALS DATABASES 26

• Product pipelines grow while deal making activity declines 27
• Analysis of pipeline candidates by therapy area and indication indicate an increased focus on niche markets 30
  • The "big four" tumors are the most popular indications for solid tumors 35
• Molecular targeted therapies are leading a paradigm shift in oncology 36
  • Antibacterial, antifungal and antiviral pipelines all demonstrate strong growth 37
  • Novel pipeline antibacterial drugs target niche markets 37
  • Antifungal drug discovery is driven by new patient groups 38
• CNS continues to be a thriving market despite generic competition 39
  • Fibromyalgia drug development drives growth in pipeline drugs for pain 39
  • Antidepressant drug development drives the psychiatry pipeline forward 40
• Low levels of innovation hampers the growth of the cardiovascular market 41
• Ophthalmology had the largest percentage increase in number of drug candidates in clinical development 42
• Substance abuse saw a steep rise in Phase I drugs, but a decline in other stages of development 43
• Majority of Big Pharma have expanded their pipeline portfolios since 2006 46
  • Genentech and Bristol-Myers Squibb have shown a significant jump in pipeline candidates 48
  • Genentech's innovative approach spurs an enviable pipeline 48
  • Bristol-Myers Squibb's strong pipeline is attributed to its externalization strategy 49
  • Wyeth, GlaxoSmithKline and Johnson & Johnson saw a decline in their number of pipeline candidates 51
  • Wyeth is experiencing a decline in number of drug candidates due to discontinuations 51
  • GlaxoSmithKline must increase its R&D productivity to sustain future growth 52
  • Johnson & Johnson needs to bolster its early and mid-stage pipeline 53
  • Daiichi Sankyo boosts its early-stage pipeline through externalizations 54
  • Recent mergers will sharpen R&D structure 56
  • Pfizer acquired Wyeth in an effort to diversify its pipeline 56
  • Merck & Co's purchase of Schering-Plough provides R&D synergy and the addition of new therapy areas 58
  • Roche acquired the remaining stake in Genentech to foster R&D in areas of high growth 61
• Early-stage co-development deals remain the most popular deal type 63
  • Early-stage partnerships are the most popular R&D deal type, but have also seen the steepest decline in recent years 64
  • Co-development deals are most common among earlier-stage companies as well as the top 50 pharma companies 67

CHAPTER 4 BIBLIOGRAPHY 70

• Publications and online articles 70

APPENDIX 75
List of Tables 

• Table 1: Most popular targets in for drugs in development, 2009 13

List of Figures 

• Figure 1: The R&D process is failing somewhere between initial innovation and market approval 12
• Figure 2: Reasons why pipeline drug candidates are dropped, 2009 15
• Figure 3: Niche, specialty care markets offer Pharma the greatest growth potential 18
• Figure 4: Restructuring Big Pharma R&D operations to increase productivity 21
• Figure 5: Biologics will sharpen the focus of the R&D pipeline 24
• Figure 6: Biologics are changing the emphasis of the value chain 25
• Figure 7: The greatest number of pipeline candidates are in preclinical and Phase II development, this corresponds to the stages showing the greatest deal activity, 2006-Q1 2009 28
• Figure 8: Number of US licensing deals valued at $0-50m entered into by the top 20 pharma companies, Q1 2006-Q3 2008 29
• Figure 9: Change (%) in number of pipeline candidates, Q1 2009 versus 2006 31
• Figure 10: Pipeline candidates by therapy area and indication, 2006-Q1 2009 32
• Figure 11: Change in number of pipeline deals by therapy area, 2008 versus 2006 33
• Figure 12: Number of pipeline candidates versus deals according to therapy area, 2006-Q1 2009 34
• Figure 13: Level of R&D interest and unmet need for four solid tumors, 2008 36
• Figure 14: Clinical unmet needs for the main cardiovascular indications 42
• Figure 15: Vaccines have high entry barriers for generic companies 44
• Figure 16: Number of pipeline candidates (preclinical and Phase I-III) and number of deals for the top 10 pharma companies, 2006-Q1 2009 47
• Figure 17: Change (%) in number of pipeline candidates, Q1 2009 versus 2006 48
• Figure 18: Origins of Bristol-Myers Squibb's product portfolio (2008) and selected key products 50
• Figure 19: How externalization is supplementing Daiichi Sankyo's oncology pipeline 55
• Figure 20: Pfizer, Wyeth and combined Pfizer-Wyeth molecule type and therapy area configurations (% of Rx sales), 2008 57
• Figure 21: Merck & Co, Schering-Plough and combined Merck-Schering-Plough molecule type configuration (% of Rx sales), 2008 60
• Figure 22: Trends in sources and partners for pipeline drug deals in the pharma industry, 2006-08 64
• Figure 23: Trends in the source: partner mix for pipeline drug deal-making, 2006-08 65
• Figure 24: The most common pipeline deal types (2006-08) have been co-development deals although these are now declining 67
• Figure 25: Top 10 pipeline drug deal types by partner: source mix, 2006-08 68
• Figure 26: Trends in number of pipeline candidates according to development stage, 2006 - Q1 09 75
• Figure 27: Trends in number of deals according to development stage, 2006-08 76

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