New Drug Futures 2009

Date: April 22, 2009
Pages: 450
Price:
US$ 3,490.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: N3ADF099119EN
Leaflet:

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New Drug Futures 2009
The search – and need – for new products has never been greater and what’s in the development pipeline has never generated more interest.

MAJOR THERAPY AREAS ANALYSED

Anti-infectives
Cardiovascular
CNS
Gastrointestinal
Metabolic
Musculoskeletal
Oncology
Respiratory This 450-page report evaluates, compares and contrasts the prospects for the development compounds that will revolutionise the pharmaceutical industry over the next 5 years and beyond. That is why this analysis is so important!

The report provides:

Detailed background and market context for each therapy area covered:
- Addressable patient population
- Current treatments
- Sales drivers
- Sales breakers
- Future treatments
- Market dynamics – winners and losers
- Key drug launches by 2013

Unique sales forecasts by major product to 2013
Over 70 key products assessed
Unique evaluation scores for key areas such as novelty of mechanism, clinical data and competition
Critical and detailed appraisal of each product’s research and development

THE GLOBAL PHARMA MARKET IN CONTEXT

Too few novel products and an aggressive generic sector are taking their toll ... Are there too many prophets of doom ready to write-off the research-based pharma industry in the future?

There is plenty on which to base such anxiety. The research-based industry must achieve a fair price in the face of greater cost control, while the burden of regulation is setting the bar high for successful product introduction. Meanwhile, the generics sector is eating away at ageing and established portfolios.

It is a fair assessment to say that the industry has rested too much on its laurels and successful product portfolios. For too many years, too few novel medicines have been brought to market, laying the foundations for the industry’s current ills.

Can it be different?

The increasing number of biologicals that are coming to market have real potential for clinical and commercial progress, and while there is an innovation gap until new biological products make their market presence felt, there are considerable reasons to view the future more positively. A considered evaluation of the research pipeline shows that the future can be brighter than many pundits predict.

Essential analysis of 110 products that could change the face of the market

Over 70 winning drugs have been identified that could be launched by 2013. Products come from over 35 companies, ranging from multinationals and specialty pharma, to biopharmaceuticals and biotechnology companies.

Will they make it?

Our estimates assume products will gain approval for the indications we have forecast in the timeframe analysed. However, regulatory demands and pressures on cost and development budgets increasingly mean safe and effective medicines are not brought to market. That is why we provide a unique analysis of each product, examining its novelty of mechanism, clinical data, competitive environment, the experience of the developer and risks associated with development within that therapeutic class.

This report is essential reading for industry planners and investors

Anyone wanting an insightful analysis of the products and companies that will shape the global pharmaceutical industry over the next 5 years need look no further than this report.
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
Irri    Table bowel syndrome
    Table 118 Major drugs marketed for the treatment of IBS
Sales drivers
Acid-related disorders
Inflammatory bowel disease
Irri    Table bowel syndrome
Sales Breakers
Acid-related disorders
Inflammatory bowel disease
Irri    Table 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
Irri    Table 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

APPENDIX

Drug Candidates Ranked by CRA Score

ACRONYMS

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 R
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