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New Drug Futures 2009

Published by: Espicom Healthcare Intelligence

Published: Apr. 21, 2009 - 450 Pages


Table of Contents


Global Pharma Market Shares

Figure 1 Forecast worldwide prescription pharmaceutical market, 2008-2013

Cardiovascular

Central Nervous System

Oncology

Anti-infectives

Respiratory

Gastrointestinal

Musculoskeletal

Metabolic

Others

Figure 2 Estimated world prescription pharmaceutical market by therapeutic category, 2007 (total value US$554 billion)

Figure 3 Forecast world prescription pharmaceutical market by therapeutic category, 2013 (total value US$672 billion)

Pharma manufacturers

Therapy areas

Table 1 Estimated 2007 market value by therapeutic category, and forecast market value by therapeutic category, 2008-2013 (US$ billion)

Global trends in the pharmaceutical market

Emerging markets

Generic competition

Figure 4 Major US patent expiries with worldwide sales in year prior to generic competition, 2008-2013

Biosimilar agents to have limited short-term impact

Pricing and reimbursement

Payor pressures increasing in the US

Figure 5 Medicare Part D Risk Corridors for 2008-2011

Europe set to remain a tough pricing environment

Table 2 Generics in major European markets

Japan

Pipeline productivity

Figure 6 Worldwide pharmaceutical R&D spend versus US NME and BLA approvals

Figure 7 Average peak sales (US$m) per NME/BLA launch

Anti-infectives overview

Figure 8 Estimated 2007 worldwide prescription anti-infectives market

Antibiotics

Antivirals

Antifungals

Addressable patient population

Bacterial infection

Table 3 Number of hospital-treated infections in key markets (millions)

Fungal infections

Viral infections

Human immunodeficiency virus (HIV)

Hepatitis B (HBV)

Hepatitis C (HCV)

Herpes

Current treatments

Bacterial infection

Table 4 Top ten antibiotics worldwide (based on 2007 sales)

Figure 9 US antibiotic prescriptions by class, 2007

Fungal infection

Superficial infection

Systemic infections

Table 5 Major drugs used in the treatment of fungal infection

Viral infections

Human immunodeficiency virus (HIV)

Figure 10 Anti-HIV market by drug class on the basis of 2007 sales

Table 6 Major drugs used in the treatment of HIV infection

Hepatitis B (HBV)

Table 7 Major drugs used in the treatment of HBV infection

Hepatitis C (HCV)

Table 8 Major drugs used in the treatment of hepatitis C

Herpes

Table 9 Major drugs used in the treatment of herpes infection

Sales drivers

Table 10 Success rates of drug development by therapeutic area

Sales breakers

Future treatments

Table 11 Mid- to late-stage antibiotic drugs in development

Table 12 Mid- to late-stage antifungal drugs in development

Table 13 Mid- to late-stage antiviral drugs in development

Market dynamics - winners and losers

Antibiotics

Antifungals

Antivirals

Key anti-infective drug launches by 2013

Albuferon

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 14 ACHIEVE 2/3 results (ITT basis)

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 15 Forecast sales of Albuferon (US$m)

Competitor ratio analysis

boceprevir

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 16 SVR rates of all ITT patients at weeks 24 and 48, HCV SPRINT-1 study

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 17 Forecast sales of boceprevir (US$m)

Competitor ratio analysis

elvitegravir

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 18 Forecast sales of elvitegravir (US$m)

Competitor ratio analysis

telaprevir

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 19 Interim analysis of study 107 in prior treatment-failure patients

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 20 Forecast sales of telaprevir (US$m)

Competitor ratio analysis

vicriviroc

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 21 Forecast sales of vicriviroc (US$m)

Competitor ratio analysis

Zeftera

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 22 Forecast sales of Zeftera (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Cardiovascular overview

Figure 11 Worldwide cardiovascular market 2007

Addressable patient population

Current treatments

Table 23 Cardiovascular conditions and current therapies available

Arrhythmia/atrial fibrillation

Table 24 Major drugs used in the treatment of arrhythmia/AF

Dyslipidaemia

Table 25 Major drugs used in the treatment of dyslipidaemia

Hypertension

Table 26 Major drugs used in the treatment of hypertension

Thrombosis

Figure 12 Thrombosis market by percentage of patient

Table 27 Major antiplatelet agents used in the treatment of thrombosis

Table 28 Major LMWHs used in the treatment of thrombosis

Sales drivers

Sales breakers

Table 29 Major US cardiovascular patent expiries expected in 2008-2013

Future treatments

Arrhythmia

Table 30 Mid- to late-stage drugs for the treatment of arrhythmia

Dyslipidaemia

Table 31 Mid- to late-stage drugs in development for the treatment of dyslipidaemia

Hypertension

Table 32 Mid- to late-stage drugs in development for the treatment of hypertension

Thrombosis

Table 33 Mid- to late-stage drugs in development for the treatment or prevention of thrombosis

Market dynamics - winners and losers

Key cardiovascular drug launches by 2013

apixaban

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 34 Phase III EXPANSE programme

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 35 Forecast sales of apixaban (US$m)

Competitor ratio analysis

AVE -5530

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 36 Forecast sales of AVE-5530 (US$m)

Competitor ratio analysis

Azilsartan medoxomil

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 37 Forecast sales of azilsartan medoxomil (US$m)

Competitor ratio analysis

Brilinta

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 38 28-day results of DISPERSE trial with Brilinta

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 39 Forecast sales of Brilinta (US$m)

Competitor ratio analysis

Cordaptive/Tredaptive

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 40 Percentage change from baseline in lipids across weeks 12 through 24

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 41 Forecast sales of Cordaptive (US$m)

Competitor ratio analysis

Effient

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 42 Key efficacy results from the TRITON-TIMI 38 study

Table 43 Key safety data from the TRITON-TIMI 38 study

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 44 Forecast sales of Effient (US$m)

Competitor ratio analysis

idrabiotaparinux

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 45 Forecast sales of idrabiotaparinux (US$m)

Competitor ratio analysis

Multaq

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 46 Phase III programme for Multaq

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 47 Forecast sales of Multaq (US$m)

Competito ratio analysis

octaparine

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 48 Forecast sales of octaparine (US$m)

Competitor ratio analysis

Pradaxa

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 49 RE-VOLUTION clinical trial programme

Table 50 RE-NOVATE major results

Table 51 RE-MOBILIZE results

Table 52 PETRO results

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 53 Forecast sales of Pradaxa (US$m)

Competitor ratio analysis

SCH -530348

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 54 PCI cohort: bleeding results

Table 55 CABG cohort: bleeding results

Table 56 PCI cohort: cardiac events

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 57 Forecast sales of SCH-530348 (US$m)

Competitor ratio analysis

Xarelto

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 58 RECORD 3: major efficacy endpoints

Table 59 RECORD 3: major safety endpoints

Table 60 RECORD 1: key results

Table 61 RECORD 2: key results

Table 62 ODIXa-DVT study: major results

Table 63 EINSTEIN-DVT study: major results

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Table 64 Xarelto late-stage development summary

Sales forecasts and assumptions

Table 65 Forecast sales of Xarelto (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

CNS overview

Figure 13 Estimated 2007 worldwide prescription CNS market

Alzheimer’s disease

ADHD

Depression & anxiety

Epilepsy

Insomnia

Migraine

Multiple sclerosis

Pain

Parkinson’s disease

Schizophrenia

Addressable patient population

Table 66 Worldwide prevalence of CNS disorders

Current treatments

Alzheimer’s disease

Table 67 Major drugs marketed for the treatment of Alzheimer's disease

ADHD

Table 68 Major drugs marketed for ADHD

Depression and anxiety

Table 69 Major drugs marketed for the treatment of depression

Epilepsy

Table 70 Major drugs marketed for the treatment of epilepsy

Insomnia

Table 71 Major drugs marketed for the treatment of insomnia

Migraine

Table 72 Major drugs marketed for the treatment of migraine

Multiple sclerosis

Table 73 Major drugs used in the treatment of multiple sclerosis

Pain

Table 74 Major drugs used in the treatment of neuropathic pain

Parkinson’s disease

Table 75 Major drugs used in the treatment of Parkinson's disease

Schizophrenia

Table 76 Major drugs used in the treatment of schizophrenia

Sales drivers

Sales breakers

Future treatments

Alzheimer’s disease

Table 77 Mid- to late-stage drugs in development for Alzheimer's disease

ADHD

Table 78 Mid- to late-stage drugs in development for ADHD

Depression & anxiety

Table 79 Mid- to late-stage drugs in development for the treatment of depression and anxiety

Epilepsy

Table 80 Mid- to late-stage drugs in development for the treatment of epilepsy

Insomnia

Table 81 Mid- to late-stage drugs in development for the treatment of insomnia

Migraine

Table 82 Mid- to late-stage drugs in development for the treatment of migraine

Multiple sclerosis

Table 82 Mid- to late-stage drugs in development for the treatment of multiple sclerosis

Pain

Table 83 Mid- to late-stage drugs in development for the treatment of pain

Parkinson’s disease

Table 84 Mid- to late-stage drugs in development for the treatment of Parkinson's disease

Schizophrenia

Table 85 Mid- to late-stage drugs in development for the treatment of schizophrenia

Market dynamics - winners and losers

Alzheimer’s disease

ADHD

Depression & anxiety

Epilepsy

Insomnia

Migraine

Multiple sclerosis

Pain

Parkinson’s disease

Schizophrenia

Key CNS drug launches by 2013

almorexant

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 86 Almorexant Phase II data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 87 Forecast sales of almorexant (US$m)

Competitor ratio analysis

bapineuzumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Figure 14 Efficacy of bapineuzumab in ApoE4 non-carriers (MITT) ADAS-Cog by dose (mg/kg)

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 88 Forecast sales of bapineuzumab (US$m)

Competitor ratio analysis

BG-12

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 89 Forecast sales of BG-12 (US$m)

Competitor ratio analysis

Ciltyri

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 90 Ciltyri Phase III programme

Table 91 Ciltyri Phase III data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 92 Forecast sales of Ciltyri (US$m)

Competitor ratio analysis

Comfyde

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 93 Forecast sales of Comfyde (US$m)

Competitor ratio analysis

dirucotide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 1 Forecast sales of dirucotide (US$m)

Competitor ratio analysis

fingolimod

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Filings and approval

Sales forecasts and assumptions

Table 94 Forecast sales of fingolimod (US$m)

Competitor ratio analysis

lurasidone

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Figure 15 Lurasidone Phase II efficacy data: PANSS total score change

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 95 Forecast sales of lurasidone (US$m)

Competitor ratio analysis

Neurelan

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Sales forecasts and assumptions

Table 96 Forecast sales of Neurelan (US$m)

Competitor ratio analysis

Nuvigil

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 97 Average baseline sleep latency and change from baseline at final visit (MWT and MSLT in minutes)

Table 98 Clinical Global Impression of Change (CGI-C; percentage of patients who improved at final visit)

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 99 Forecast sales of Nuvigil (US$m)

Competitor ratio analysis

ralfinamide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 100 Ralfinamide Phase II: efficacy in peripheral neuropathic pain

Table 101 Ralfinamide Phase II: efficacy in NCET

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 101 Forecast sales of ralfinamide (US$m)

Competitor ratio analysis

Retigabine

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 102 Forecast sales of retigabine (US$m)

Competitor ratio analysis

Rikelta

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 103 Rikelta Phase II clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 104 Forecast sales of Rikelta (US$m)

Competitor ratio analysis

Saphris

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 105 Forecast sales of Saphris (US$m)

Competitor ratio analysis

saredutant

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 106 Saredutant in MDD: safety in Phase III completed studies

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 107 Forecast sales of saredutant (US$m)

Competitor ratio analysis

tapentadol

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 108 Forecast sales of tapentadol (US$m)

Competitor ratio analysis

telcagepant

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 109 Results from placebo-controlled Phase III trial

Table 110 Results from Phase III trial with comparison to Zomig

Table 111 Two-hour response rates with telcagepant versus Maxalt and placebo

Table 112 Sustained pain freedom results with telcagepant versus Maxalt and placebo

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 112 Forecast sales of telcagepant (US$m)

Competitor ratio analysis

Valdoxan

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 113 Valdoxan dose-ranging trial

Table 114 Summary of efficacy studies for Valdoxan in treatment of MDD included in original MAA submission

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 115 Forecast sales of Valdoxan (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Gastrointestinal overview

Figure 16 Worldwide prescription gastrointestinal market 2007

Acid-related disorders

Inflammatory bowel disease

Irritable bowel syndrome

Addressable patient population

Acid-related disorders

Irritable bowel syndrome

Current treatments

Acid-related disorders

Table 116 Major drugs used in the treatment of acid-related GI disorders

Inflammatory bowel disease

Table 117 Major drugs used in the treatment of IBD

Irritable bowel syndrome

Table 118 Major drugs marketed for the treatment of IBS

Sales drivers

Acid-related disorders

Inflammatory bowel disease

Irritable bowel syndrome

Sales Breakers

Acid-related disorders

Inflammatory bowel disease

Irritable bowel syndrome

Future treatments

Acid-related disorders

Table 119 Mid- to late-stage drugs in development for the treatment of GORD and related disorders

Inflammatory bowel disease

Table 120 Mid- to late-stage drugs in development for the treatment of IBD

Irritable bowel syndrome

Table 121 Mid- to late-stage drugs in development for IBS

Market dynamics - winners and losers

Key gastrointestinal drug launches by 2013

AD X10059

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 122 Forecast sales of ADX10059 in GORD (US$m)

Competitor ratio analysis

Kapidex DR

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 123 Forecast sales of Kapidex DR (US$m)

Competitor ratio analysis

Linaclotide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 124 Forecast sales of linaclotide (US$m)

Competitor ratio analysis

Rezular

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 125 Forecast sales of Rezular (US$m)

Competitor ratio analysis

Vedolizumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 126 Forecast sales of vedolizumab (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Metabolic overview

Figure 17 Worldwide metabolic market 2007

Insulins

Non-insulin diabetes agents

Figure 18 Non-insulin treatments for diabetes by value, 2007

Obesity

Addressable patient population

Type II diabetes

Type I diabetes

Figure 19 Incidence of Type I diabetes in children aged 0-14 years

Obesity

Figure 20 Increasing prevalence of obesity in the US

Figure 21 Rates of obesity in five major European countries

Current treatments

Diabetes

Figure 22 Diabetes treatment in the US in diagnosed patients, 2004-2006

Insulins

Table 127 Major insulin products used in the treatment of diabetes

Non-insulin diabetes agents

Table 128 Major non-insulin agents for the treatment of Type II diabetes

Obesity

Table 129 Major drugs marketed for the treatment of obesity

Sales drivers

Diabetes

Obesity

Sales breakers

Diabetes

Obesity

Future treatments

Insulins

Table 130 Mid- to late-stage insulins in development

Non insulin diabetes agents

Table 131 Mid- to late-stage non insulin diabetes agents in development

Obesity

Table 132 Mid- to late-stage drugs in development for the treatment of obesity

Market dynamics - winners and losers

Insulins

Non-insulin diabetes agents

Obesity

Key metabolic drug launches by 2013

Alogliptin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 133 Phase III alogliptin data summary

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 134 Forecast sales of alogliptin (US$m)

Competitor ratio analysis

Byetta LAR

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 135 Forecast sales of Byetta LAR (US$m)

Competitor ratio analysis

Dapagliflozin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 136 Mean changes from baseleine at week 12

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 137 Forecast sales of dapagliflozin (US$m)

Competitor ratio analysis

Lixisenatide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 138 Forecast sales of lixisenatide (US$m)

Competitor ratio analysis

Lorcaserin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 139 Weight change: day 85 - baseline (completer analysis)

Table 140 Lorcaserin Phase IIb Adverse Events >5% in Any Group

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 141 Forecast sales of lorcaserin (US$m)

Competitor ratio analysis

Metaglidasen

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 142 Forecast sales of metaglidasen (US$m)

Competitor ratio analysis

Onglyza

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 143 Forecast sales of Onglyza (US$m)

Competitor ratio analysis

Velneperit

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 144 Forecast sales of velneperit (US$m)

Competitor ratio analysis

Victoza

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 145 Key LEAD 3 data

Table 146 Key LEAD 4 data

Table 147 Key LEAD 6 data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 148 Forecast sales of Victoza (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Musculoskeletal overview

Figure 23 Worldwide musculoskeletal sales 2007

Addressable patient population

Rheumatoid arthritis

Osteoarthritis

Osteoporosis

Current treatments

Rheumatoid arthritis

Table 149 Major DMARDs used in the treatment of rheumatoid arthritis

Osteoarthritis

Table 150 Major drugs used in the treatment of osteoarthritis

Osteoporosis

Table 151 Major drugs used in the treatment of osteoporosis

Sales drivers

Sales breakers

Future treatments

Rheumatoid arthritis

Table 152 Mid- to late-stage drugs in development for the treatment of rheumatoid arthritis

Osteoarthritis

Table 153 Mid- to late-stage drugs in development for the treatment of osteoarthritis

Osteoporosis

Table 154 Mid- to late-stage drugs in development for the treatment of osteoporosis

Market dynamics - winners and losers

Key musculoskeletal drug launches by 2013

Actemra

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 155 Roche's Phase III programme for Actemra

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 156 Forecast sales of Actemra (US$m)

Competitor ratio analysis

Azerra - RA

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 157 Forecast sales of Arzerra in rheumatoid arhritis (US$m)

Competitor ratio analysis

Denosumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Table 158 Phase III denosumab versus Fosamax head-to-head safety results

Filings and approval

Sales forecasts and assumptions

Table 159 Forecast sales of denosumab (US$m)

Competitor ratio analysis

Fablyn/Oporia

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 160 Analysis of time-to-first new/worsening radiographic vertebral fracture

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 161 Forecast sales of Fablyn (US$m)

Competitor ratio analysis

Golimumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 162 Golimumab RA Phase III programme

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Table 163 Anti-TNF agents in the treatment of RA

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 164 Forecast sales of golimumab (US$m)

Competitor ratio analysis

Ocrelizumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 165 Forecast sales of ocrelizumab (US$m)

Competitor ratio analysis

Viviant

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 166 Forecast sales of Viviant (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Oncology overview

Figure 24 Worldwide oncology sales 2007

Addressable patient population

Table 167 Leading sites of new cancer cases and deaths worldwide 2007

Current treatments

Chemotherapy

Alkylating agents

Table 168 Major alkylating agents used in the treatment of cancer

Anti-metabolites

Table 169 Major anti-metabolites used in the treatment of cancer

Topoisomerase inhibitors

Table 170 Major topoisomerase inhibitors used in the treatment of cancer

Antimitotics

Table 171 Major antimitotic agents used in the treatment of cancer

Targeted therapies

Table 172 Targeted agents used in the treatment of cancer

Hormonal therapies

Table 173 Major hormonal therapies used in the treatment of cancer

Supportive care

Table 174 Major drugs used in the supportive care of cancer

Oncology sales drivers

Oncology sales breakers

Future treatments

Figure 25 Drugs in development for cancer*

Table 175 Mid- to late-stage agents in development for the treatment of cancer (excluding cancer vaccines)

Oncology supportive care

Table 176 Mid- to late-stage drugs in development for supportive care indications

Market dynamics - winners and losers

Table 177 Key growth drivers within the oncology market

Key oncology drug launches by 2013

Afinitor

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 178 Forecast sales of Afinitor (US$m)

Competitor ratio analysis

Aflibercept

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Table 179 Regulatory submissions for aflibercept

Sales forecasts and assumptions

Table 180 Forecast sales of aflibercept (US$m)

Competitor ratio analysis

Armala

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 181 Forecast sales of Armala (US$m)

Competitor ratio analysis

Arzerra

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 182 Phase I/II NHL trial results summary

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 183 Forecast sales of Arzerra in CLL (US$m)

Table 184 Forecast sales of Arzerra in NHL (US$m)

Competitor ratio analysis

Bosutinib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 185 Forecast sales of Bosutinib (US$m)

Competitor ratio analysis

Deforolimus

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 186 Forecast sales of deforolimus (US$m)

Competitor ratio analysis

Elesclomol

Proof of concept/clinical data

Table 187 Phase IIb study results of elesclomol in metastatic melanoma

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 188 Forecast sales of elesclomol (US$m)

Competitor ratio analysis

Eribulin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 189 Forecast sales of eribulin (US$m)

Competitor ratio analysis

Ipilimumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 190 Forecast sales of ipilimumab (US$m)

Competitor ratio analysis

Pertuzumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 191 Forecast sales of pertuzumab (US$m)

Competitor ratio analysis

Pixantrone

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 192 Forecast sales of pixantrone (US$m)

Competitor ratio analysis

Zactima

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 193 Zactima Phase III programme in NSCLC

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 194 Forecast sales of Zactima (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

Respiratory overview

Figure 26 Worldwide respiratory market 2007

Asthma

Rhinitis

COPD

Addressable patient population

Asthma

COPD

Rhinitis

Current treatments

Asthma

Table 195 Major drugs used in the treatment of asthma

COPD

Table 197 Major drugs used in the treatment of COPD

Rhinitis

Table 196 Major drugs used in the treatment of rhinitis

Future treatments

Asthma

Table 198 Mid- to late-stage drugs in development for the treatment of asthma

COPD

Table 199 Mid- to late-stage drugs in development for the treatment of COPD

Rhinitis

Respiratory sales drivers

Asthma

COPD

Respiratory sales breakers

Asthma

COPD

Market dynamics - winners and losers

Key respiratory drug launches by 2013

Aclidinium bromide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Table 200 Adverse events in ACCLAIM studies, compared to Spiriva

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 201 Forecast sales of aclidinium bromide (US$m)

Competitor ratio analysis

Daxas

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Table 202 Incidence of side effects following Daxas treatment

Filings and approval

Sales forecasts and assumptions

Table 203 Forecast sales of Daxas (US$m)

Competitor ratio analysis

Glycopyrronium bromide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 204 Forecast sales of glycopyrronium bromide (US$m)

Competitor ratio analysis

Indacaterol

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Table 205 Forecast sales of indacaterol (US$m)

Competitor ratio analysis

Competitor Ratio Analysis Summary

APPENDI X

Drug Candidates Ranked by CRA Score

ACRONYM S

Footnotes

Index of Tables

Table 1 Estimated 2007 market value by therapeutic category, and forecast market value by therapeutic category, 2008-2013 (US$ billion)

Table 2 Generics in major European markets

Table 3 Number of hospital-treated infections in key markets (millions)

Table 4 Top ten antibiotics worldwide (based on 2007 sales)

Table 5 Major drugs used in the treatment of fungal infection

Table 6 Major drugs used in the treatment of HIV infection

Table 7 Major drugs used in the treatment of HBV infection

Table 8 Major drugs used in the treatment of hepatitis C

Table 9 Major drugs used in the treatment of herpes infection

Table 10 Success rates of drug development by therapeutic area

Table 11 Mid- to late-stage antibiotic drugs in development

Table 12 Mid- to late-stage antifungal drugs in development

Table 13 Mid- to late-stage antiviral drugs in development

Table 14 ACHIEVE 2/3 results (ITT basis)

Table 15 Forecast sales of Albuferon (US$m)

Table 16 SVR rates of all ITT patients at weeks 24 and 48, HCV SPRINT-1 study

Table 17 Forecast sales of boceprevir (US$m)

Table 18 Forecast sales of elvitegravir (US$m)

Table 19 Interim analysis of study 107 in prior treatment-failure patients

Table 20 Forecast sales of telaprevir (US$m)

Table 21 Forecast sales of vicriviroc (US$m)

Table 22 Forecast sales of Zeftera (US$m)

Table 23 Cardiovascular conditions and current therapies available

Table 24 Major drugs used in the treatment of arrhythmia/AF

Table 25 Major drugs used in the treatment of dyslipidaemia

Table 26 Major drugs used in the treatment of hypertension

Table 27 Major antiplatelet agents used in the treatment of thrombosis

Table 28 Major LMWHs used in the treatment of thrombosis

Table 29 Major US cardiovascular patent expiries expected in 2008-2013

Table 30 Mid- to late-stage drugs for the treatment of arrhythmia

Table 31 Mid- to late-stage drugs in development for the treatment of dyslipidaemia

Table 32 Mid- to late-stage drugs in development for the treatment of hypertension

Table 33 Mid- to late-stage drugs in development for the treatment or prevention of thrombosis

Table 34 Phase III EXPANSE programme

Table 35 Forecast sales of apixaban (US$m)

Table 36 Forecast sales of AVE-5530 (US$m)

Table 37 Forecast sales of azilsartan medoxomil (US$m)

Table 38 28-day results of DISPERSE trial with Brilinta

Table 39 Forecast sales of Brilinta (US$m)

Table 40 Percentage change from baseline in lipids across weeks 12 through 24

Table 41 Forecast sales of Cordaptive (US$m)

Table 42 Key efficacy results from the TRITON-TIMI 38 study

Table 43 Key safety data from the TRITON-TIMI 38 study

Table 44 Forecast sales of Effient (US$m)

Table 45 Forecast sales of idrabiotaparinux (US$m)

Table 46 Phase III programme for Multaq

Table 47 Forecast sales of Multaq (US$m)

Table 48 Forecast sales of octaparine (US$m)

Table 49 RE-VOLUTION clinical trial programme

Table 50 RE-NOVATE major results

Table 51 RE-MOBILIZE results

Table 52 PETRO results

Table 53 Forecast sales of Pradaxa (US$m)

Table 54 PCI cohort: bleeding results

Table 55 CABG cohort: bleeding results

Table 56 PCI cohort: cardiac events

Table 57 Forecast sales of SCH-530348 (US$m)

Table 58 RECORD 3: major efficacy endpoints

Table 59 RECORD 3: major safety endpoints

Table 60 RECORD 1: key results

Table 61 RECORD 2: key results

Table 62 ODIXa-DVT study: major results

Table 63 EINSTEIN-DVT study: major results

Table 64 Xarelto late-stage development summary

Table 65 Forecast sales of Xarelto (US$m)

Table 66 Worldwide prevalence of CNS disorders

Table 67 Major drugs marketed for the treatment of Alzheimer's disease

Table 68 Major drugs marketed for ADHD

Table 69 Major drugs marketed for the treatment of depression

Table 70 Major drugs marketed for the treatment of epilepsy

Table 71 Major drugs marketed for the treatment of insomnia

Table 72 Major drugs marketed for the treatment of migraine

Table 73 Major drugs used in the treatment of multiple sclerosis

Table 74 Major drugs used in the treatment of neuropathic pain

Table 75 Major drugs used in the treatment of Parkinson's disease

Table 76 Major drugs used in the treatment of schizophrenia

Table 77 Mid- to late-stage drugs in development for Alzheimer's disease

Table 78 Mid- to late-stage drugs in development for ADHD

Table 79 Mid- to late-stage drugs in development for the treatment of depression and anxiety

Table 80 Mid- to late-stage drugs in development for the treatment of epilepsy

Table 81 Mid- to late-stage drugs in development for the treatment of insomnia

Table 82 Mid- to late-stage drugs in development for the treatment of migraine

Table 82 Mid- to late-stage drugs in development for the treatment of multiple sclerosis

Table 83 Mid- to late-stage drugs in development for the treatment of pain

Table 84 Mid- to late-stage drugs in development for the treatment of Parkinson's disease

Table 85 Mid- to late-stage drugs in development for the treatment of schizophrenia

Table 86 Almorexant Phase II data

Table 87 Forecast sales of almorexant (US$m)

Table 88 Forecast sales of bapineuzumab (US$m)

Table 89 Forecast sales of BG-12 (US$m)

Table 90 Ciltyri Phase III programme

Table 91 Ciltyri Phase III data

Table 92 Forecast sales of Ciltyri (US$m)

Table 93 Forecast sales of Comfyde (US$m)

Table 1 Forecast sales of dirucotide (US$m)

Table 94 Forecast sales of fingolimod (US$m)

Table 95 Forecast sales of lurasidone (US$m)

Table 96 Forecast sales of Neurelan (US$m)

Table 97 Average baseline sleep latency and change from baseline at final visit (MWT and MSLT in minutes)

Table 98 Clinical Global Impression of Change (CGI-C; percentage of patients who improved at final visit)

Table 99 Forecast sales of Nuvigil (US$m)

Table 100 Ralfinamide Phase II: efficacy in peripheral neuropathic pain

Table 101 Ralfinamide Phase II: efficacy in NCET

Table 101 Forecast sales of ralfinamide (US$m)

Table 102 Forecast sales of retigabine (US$m)

Table 103 Rikelta Phase II clinical data

Table 104 Forecast sales of Rikelta (US$m)

Table 105 Forecast sales of Saphris (US$m)

Table 106 Saredutant in MDD: safety in Phase III completed studies

Table 107 Forecast sales of saredutant (US$m)

Table 108 Forecast sales of tapentadol (US$m)

Table 109 Results from placebo-controlled Phase III trial

Table 110 Results from Phase III trial with comparison to Zomig

Table 111 Two-hour response rates with telcagepant versus Maxalt and placebo

Table 112 Sustained pain freedom results with telcagepant versus Maxalt and placebo

Table 112 Forecast sales of telcagepant (US$m)

Table 113 Valdoxan dose-ranging trial

Table 114 Summary of efficacy studies for Valdoxan in treatment of MDD included in original MAA submission

Table 115 Forecast sales of Valdoxan (US$m)

Table 116 Major drugs used in the treatment of acid-related GI disorders

Table 117 Major drugs used in the treatment of IBD

Table 118 Major drugs marketed for the treatment of IBS

Table 119 Mid- to late-stage drugs in development for the treatment of GORD and related disorders

Table 120 Mid- to late-stage drugs in development for the treatment of IBD

Table 121 Mid- to late-stage drugs in development for IBS

Table 122 Forecast sales of ADX10059 in GORD (US$m)

Table 123 Forecast sales of Kapidex DR (US$m)

Table 124 Forecast sales of linaclotide (US$m)

Table 125 Forecast sales of Rezular (US$m)

Table 126 Forecast sales of vedolizumab (US$m)

Table 127 Major insulin products used in the treatment of diabetes

Table 128 Major non-insulin agents for the treatment of Type II diabetes

Table 129 Major drugs marketed for the treatment of obesity

Table 130 Mid- to late-stage insulins in development

Table 131 Mid- to late-stage non insulin diabetes agents in development

Table 132 Mid- to late-stage drugs in development for the treatment of obesity

Table 133 Phase III alogliptin data summary

Table 134 Forecast sales of alogliptin (US$m)

Table 135 Forecast sales of Byetta LAR (US$m)

Table 136 Mean changes from baseleine at week 12

Table 137 Forecast sales of dapagliflozin (US$m)

Table 138 Forecast sales of lixisenatide (US$m)

Table 139 Weight change: day 85 - baseline (completer analysis)

Table 140 Lorcaserin Phase IIb Adverse Events >5% in Any Group

Table 141 Forecast sales of lorcaserin (US$m)

Table 142 Forecast sales of metaglidasen (US$m)

Table 143 Forecast sales of Onglyza (US$m)

Table 144 Forecast sales of velneperit (US$m)

Table 145 Key LEAD 3 data

Table 146 Key LEAD 4 data

Table 147 Key LEAD 6 data

Table 148 Forecast sales of Victoza (US$m)

Table 149 Major DMARDs used in the treatment of rheumatoid arthritis

Table 150 Major drugs used in the treatment of osteoarthritis

Table 151 Major drugs used in the treatment of osteoporosis

Table 152 Mid- to late-stage drugs in development for the treatment of rheumatoid arthritis

Table 153 Mid- to late-stage drugs in development for the treatment of osteoarthritis

Table 154 Mid- to late-stage drugs in development for the treatment of osteoporosis

Table 155 Roche's Phase III programme for Actemra

Table 156 Forecast sales of Actemra (US$m)

Table 157 Forecast sales of Arzerra in rheumatoid arhritis (US$m)

Table 158 Phase III denosumab versus Fosamax head-to-head safety results

Table 159 Forecast sales of denosumab (US$m)

Table 160 Analysis of time-to-first new/worsening radiographic vertebral fracture

Table 161 Forecast sales of Fablyn (US$m)

Table 162 Golimumab RA Phase III programme

Table 163 Anti-TNF agents in the treatment of RA

Table 164 Forecast sales of golimumab (US$m)

Table 165 Forecast sales of ocrelizumab (US$m)

Table 166 Forecast sales of Viviant (US$m)

Table 167 Leading sites of new cancer cases and deaths worldwide 2007

Table 168 Major alkylating agents used in the treatment of cancer

Table 169 Major anti-metabolites used in the treatment of cancer

Table 170 Major topoisomerase inhibitors used in the treatment of cancer

Table 171 Major antimitotic agents used in the treatment of cancer

Table 172 Targeted agents used in the treatment of cancer

Table 173 Major hormonal therapies used in the treatment of cancer

Table 174 Major drugs used in the supportive care of cancer

Table 175 Mid- to late-stage agents in development for the treatment of cancer (excluding cancer vaccines)

Table 176 Mid- to late-stage drugs in development for supportive care indications

Table 177 Key growth drivers within the oncology market

Table 178 Forecast sales of Afinitor (US$m)

Table 179 Regulatory submissions for aflibercept

Table 180 Forecast sales of aflibercept (US$m)

Table 181 Forecast sales of Armala (US$m)

Table 182 Phase I/II NHL trial results summary

Table 183 Forecast sales of Arzerra in CLL (US$m)

Table 184 Forecast sales of Arzerra in NHL (US$m)

Table 185 Forecast sales of Bosutinib (US$m)

Table 186 Forecast sales of deforolimus (US$m)

Table 187 Phase IIb study results of elesclomol in metastatic melanoma

Table 188 Forecast sales of elesclomol (US$m)

Table 189 Forecast sales of eribulin (US$m)

Table 190 Forecast sales of ipilimumab (US$m)

Table 191 Forecast sales of pertuzumab (US$m)

Table 192 Forecast sales of pixantrone (US$m)

Table 193 Zactima Phase III programme in NSCLC

Table 194 Forecast sales of Zactima (US$m)

Table 195 Major drugs used in the treatment of asthma

Table 197 Major drugs used in the treatment of COPD

Table 196 Major drugs used in the treatment of rhinitis

Table 198 Mid- to late-stage drugs in development for the treatment of asthma

Table 199 Mid- to late-stage drugs in development for the treatment of COPD

Table 200 Adverse events in ACCLAIM studies, compared to Spiriva

Table 201 Forecast sales of aclidinium bromide (US$m)

Table 202 Incidence of side effects following Daxas treatment

Table 203 Forecast sales of Daxas (US$m)

Table 204 Forecast sales of glycopyrronium bromide (US$m)

Table 205 Forecast sales of indacaterol (US$m)

Drug Candidates Ranked by CRA Score

Index of Charts

Figure 1 Forecast worldwide prescription pharmaceutical market, 2008-2013

Figure 2 Estimated world prescription pharmaceutical market by therapeutic category, 2007 (total value US$554 billion)

Figure 3 Forecast world prescription pharmaceutical market by therapeutic category, 2013 (total value US$672 billion)

Figure 4 Major US patent expiries with worldwide sales in year prior to generic competition, 2008-2013

Figure 5 Medicare Part D Risk Corridors for 2008-2011

Figure 6 Worldwide pharmaceutical R&D spend versus US NME and BLA approvals

Figure 7 Average peak sales (US$m) per NME/BLA launch

Figure 8 Estimated 2007 worldwide prescription anti-infectives market

Figure 9 US antibiotic prescriptions by class, 2007

Figure 10 Anti-HIV market by drug class on the basis of 2007 sales

Figure 11 Worldwide cardiovascular market 2007

Figure 12 Thrombosis market by percentage of patient

Figure 13 Estimated 2007 worldwide prescription CNS market

Figure 14 Efficacy of bapineuzumab in ApoE4 non-carriers (MITT) ADAS-Cog by dose (mg/kg)

Figure 15 Lurasidone Phase II efficacy data: PANSS total score change

Figure 16 Worldwide prescription gastrointestinal market 2007

Figure 17 Worldwide metabolic market 2007

Figure 18 Non-insulin treatments for diabetes by value, 2007

Figure 19 Incidence of Type I diabetes in children aged 0-14 years

Figure 20 Increasing prevalence of obesity in the US

Figure 21 Rates of obesity in five major European countries

Figure 22 Diabetes treatment in the US in diagnosed patients, 2004-2006

Figure 23 Worldwide musculoskeletal sales 2007

Figure 24 Worldwide oncology sales 2007

Figure 25 Drugs in development for cancer*

Figure 26 Worldwide respiratory market 2007

Abstract

This new major and insightful 450 page analysis evaluates, compares and contrasts the prospects for the development compounds that could revolutionise the pharmaceutical industry over the next 5 years and beyond. The report covers 8 key therapy areas: anti-infectives,cardiovascular, CNS, gastrointestinal, metabolic, musculoskeletal, oncology, respiratory.

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