Gastrointestinal Drug Discoveries: what the future holds

Table of Contents

• Foreword
• Executive Summary
• Inflammatory Bowel Disease
• What is inflammatory bowel disease?
• Risk factors in the development of IBD
• Where in the world?
• The IBD therapy market
• IBD management
• Current treatment options
  • Aminosalicylates
  • Sulphasalazine
  • Oral Mesalamine
  • Topical Mesalamine
  • Olsalazine
  • Balsalazide
  • Corticosteroids
    • Prednisone
    • Budesonide
    • Hydrocortisone
  • Immunosuppressants
    • 6-mercaptopurine
    • Azathioprine
    • Cyclosporine
    • Methotrexate
  • Tumour necrosis factor alpha inhibitors
• What' s in the pipeline?
  • Potential new drugs for IBD
• Competitor ratio analysis
• Tumour necrosis factor alpha inhibitors
  • Remicade (infliximab)
    • Sales forecast
    • Clinical trial results
      • Paediatric Crohn' s Disease
      • Ulcerative Colitis
  • Humira (adalimumab)
    • Sales forecast
  • Competitor ratio analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within the marketplace
    • Risks associated with drug development in therapeutic class
  • Clinical trial results
    • CHARM
    • GAIN
    • CLASSIC
• Cimzia (certolizumab pegol)
  • Sales forecast and assumptions
  • Competitor ratio analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within the marketplace
    • Risks associated with drug development in therapeutic class
  • Clinical trial results
    • PRECiSE clinical trial programme
• RDP58 (delmitide)
  • Competitor ratio analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within the marketplace
    • Risks associated with drug development in therapeutic class
  • Clinical trial results
• Golimumab
  • Sales forecast and assumptions
  • Competitor ratio analysis
    • Novelty/rationale for mechanism of action
    • Proof of concept/clinical data
    • Management/clinical expertise
    • Competition within the marketplace
    • Risks associated with drug development in therapeutic class
• Cell adhesion molecule inhibitors
  • Tysabri (natalizumab)
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
      • ENACT-1/ENACT-2
      • ENCORE
  • Alicaforsen
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
      • Phase II
  • Firategrast (SB683699)
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • MLN0002
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• Novel corticosteroids
  • COLAL-PRED (prednisolone)
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
      • Phase II trial for UC
• T-cell modulators
  • Nuvion (visilizumab)
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Orencia (abatacept)
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
• Immune system modulators
  • Alequel
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• Interleukin inhibitors
  • ABT-874
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
      • Cohort 1/2
  • STA-5326
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• MAP kinase inhibitors
  • Semapimod
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• Others
  • Traficet-EN
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • AST-120
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • HMPL-004
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Promising early-stage development candidates
• Irritable Bowel Syndrome
• What is irritable bowel syndrome?
• Where in the world?
• The IBS therapy market
• IBS management
• Current treatment options
  • Antispasmodics
  • Laxatives
  • Antidiarrhoeal agents
  • Antidepressants
  • Serotonergic agents
• What' s in the pipeline?
  • Potential new drugs for IBS
• Competitor ratio analysis
• Serotonergic Agents
  • Lotronex (alosetron)
    • Clinical trial results
  • Zelnorm (tegaserod)
    • Sales forecast
    • Clinical trial results
      • IBS with mixed bowel pattern
  • DDP225
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • DDP733
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Renzapride
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• Others
  • Amitiza (lubiprostone)
    • Sales forecast and assumptions
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Linaclotide acetate
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Dexloxiglumide
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
      • DARWIN
  • Dextofisopam
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Xifaxan (rifaximin)
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • Crofelemer
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• Gastro-oesophageal Reflux Disease
• What is gastro-oesophageal reflux disease?
• The GORD therapy market
• GORD management
• H2 receptor antagonists
  • Pepcid/Gaster (famotidine)
    • Sales forecast
  • Zantac (ranitidine)
    • Sales forecast
  • Axid (nizatidine)
  • Tagamet (cimetidine)
• Proton pump inhibitors
  • AcipHex/Pariet (rabeprazole)
    • Sales forecast
  • Nexium (esomeprazole)
    • Sales forecast
  • Prevacid (lansoprazole)
    • Sales forecast
  • Losec/Prilosec (omeprazole)
    • Sales forecast
  • Protonix (pantoprazole)
    • Sales forecast
• What' s in the pipeline?
• Competitor ratio analysis
• Potential new drugs for GORD
  • ATI-7505
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • DDP733
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • OX 17
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
  • ADX10059
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
  • XP19986
    • Competitor ratio analysis
      • Novelty/rationale for mechanism of action
      • Proof of concept/clinical data
      • Management/clinical expertise
      • Competition within the marketplace
      • Risks associated with drug development in therapeutic class
    • Clinical trial results
• SOURCES
• Espicom Sources
• Others

List of Tables

• Genes associated with IBD
• IBD patient forecasts 2005-2012
• Currently available aminosalicylates
• Currently available corticosteroids
• Immunosuppressants currently used in IBD
• Drugs in developmentfor IBD
• Competitor ratio analysis summary
• Remicade sales, 2002-2006 (US$ millions)
• Humira sales, 2003-2006 (US$ millions)
• Currently available antidepressants
• Drugs in development for IBS
• Competitor ratio analysis summary
• Competitor Ratio Score: 42
• Sales of leading drugs used in GORD management (US$ millions)
• Approved H2 receptor antagonists
• Gaster Sales, 2003-2007 (¥ & US$ million)
• Zantac sales, 2002-2006 (£ & US$ million)
• Approved proton pump inhibitors
• AcipHex/Pariet sales, 2002-2006 (¥ & US$ million)
• Nexium sales, 2002-2006 (US$ million)
• Prevacid/Takepron sales, 2002-2006 (¥ & US$ million)
• Losec/Prilosec sales, 2002-2006 (US$ million)
• Protonix/Pantozol sales, 2002-2006 (EUR & US$ million)
• Drugs in development for GORD
• Competitor ratio analysis summary

List of Figures

• IBD prevalence 2007
• Drugs in clinical development for IBD by activity
• Remicade projected sales, 2006-2012 (US$ million)
• Humira projected sales 2006-2012 (US$ millions)
• Cimzia projected sales 2008-2012 (US$ millions)
• Golimumab projected sales, 2010-2014 (US$ million)
• ABT-874 projected sales, 2009-2014 (US$ millions)
• Amitiza, projected sales 2006-2012 (US$ millions)
• Gaster projected sales, 2007-2012 (US$ Million)
• Zantac projected sales, 2006-2012 (US$ million)
• AcipHex/Pariet projected sales, 2007-2012 (US$ million)
• Nexium projected sales, 2006-2012 (US$ million)
• Prevacid/Takepron projected sales, 2006-2012 (US$ million)
• Losec/Prilosec projected sales, 2006-2012 (US$ million)
• Protonix/Pantozol projected sales, 2006-2012 (US$ million)