Gastrointestinal Drug Discoveries

Date: January 22, 2008
Pages: 148
Price:
US$ 1,740.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: G8E8A70552FEN
Leaflet:

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Gastrointestinal Drug Discoveries
Over 145 pages of product analysis and forecasts
Unique market share and 5-year sales forecasts for leading products & prospects
A comprehensive examination of major gastrointestinal therapy areas
Critical competitive evaluation and scoring of current and up and coming products

Providing…

Detailed analysis and 5-year forecasts for current leading products by value
A detailed review and assessment of up and coming products
Unique product evaluation and scoring
An examination of the current understanding of IBD, IBS and GORD

Major approaches including
Tumour necrosis factor alpha inhibitors
Cell adhesion molecule inhibitors
T-cell modulators
Interleukin inhibitors
Serotonergic agents
H2 receptor antagonists
Proton pump inhibitors

THE REPORT COVERS MAJOR DISEASE AREAS

Inflammatory bowel disease (Crohn’s disease & ulcerative colitis)
Irritable bowel syndrome
Gastro-oesophageal reflux disease (GORD)

THE FACTS

Risk factors, how the disease affects patients, diagnosis and stages of the disease

PATIENT STATISTICS

Prevalence in the US, Europe and Japan
Diagnosis rates

CURRENT TREATMENT OPTIONS

Interventions by type
Unique five point competitive assessment and scoring of current therapies and companies involved
Sales forecasts for key products to 2012

R&D: DRUGS IN PHASE II/III

Focus on new classes of drugs and the companies involved
Unique competitive assessment and scoring of new therapies and companies involved
5-year sales forecasts for key products from year of launch

EXTENSIVE TABLES AND CHARTS

Low levels of diagnosis and new biological approaches to treatment indicate a positive future for GI drugs. Even so, opportunities in a number of areas remain to be exploited


Inflammatory Bowel Disease

An estimated two million people in the US, Europe and Japan suffer from inflammatory bowel disease (IBD), a little over half of whom have ulcerative colitis and around 800,000 of whom have Crohn’s disease. We expect the number of IBD patients around the world to increase to around 1.3 million people by 2012 and that the worldwide market for IBD to experience steady growth over the next five years. The main driving forces behind IBD market expansion will be the increased uptake of current and novel high-priced biological agents and growth of the diagnosed prevalent populations in the US and UK. These novel products will provide more treatment options for patients whose disease is unresponsive to less expensive, conventional IBD therapies (i.e., aminosalicylates, immunosuppressants, and corticosteroids). The availability of additional biologics will expand the percentage of IBD patients treated with these agents as an alternative biological agent is likely to be prescribed if the first one should fail.

Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) affects around 18% of the general population at some time. It is one of the most common disorders seen by physicians. The overall cost to the US healthcare system alone is around US$20-30 billion annually. A number of pharmaceutical companies believe that a safe and effective treatment for IBS could be worth up to US$4 billion. Despite this, there are very few therapies on the market aimed specifically at treating IBS. Patients’ symptoms have traditionally been controlled by laxatives, anti-diarrhoeals, anticholinergics and antidepressants. More recently, two serotonergic agents have been released for this condition: GlaxoSmithKline’s Lotronex (alosetron) and Novartis’ Zelnorm (tegaserod), both of which have safety issues. The majority of IBS drugs currently in development aim to treat this disorder via novel mechanisms, the most promising of which are Sucampo Pharmaceuticals/Takeda’s Amitiza (lubiprostone) and Microbia/Forest Laboratories’ Linaclotide acetate. Both drugs act locally to increase fluid secretion into the gut. Amitiza has been filed for the treatment of constipation-predominant IBS, and Linaclotide acetate is in Phase II development for the same indication.

Gastro-oesophageal Reflux Disease

The combined market for H2 receptor antagonists and proton pump inhibitors, the two major GORD therapies currently in the marketplace, is estimated to be worth around US$25 billion. Sales of the leading branded PPIs, such as Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) amounted to US$14.2 billion in 2006. However, currently available acid-suppression therapies are not adequately effective in all patients. New approaches are being pursued and are aimed at those patients who respond poorly or not at all to acid suppression therapy. One of these drugs is a promotility agent and three are aimed at tightening the lower oesophageal sphincter, thereby stopping the mechanism that results in GORD.

The products evaluated and forecast to 2012 include

ABT 874
AcipHex/Pariet
ADX10059
Amitiza
ATI-7505
Cimzia
DDP733
Golimumab
Humira
Losec/Prilosec
MLN0002
Nexium
Orencia
OX17
Pepcid/Glaster
Prevacid
Protonix
Remicade
STA 5326
Tysbari
XP19986
Zantac
Zelnorm

Questions answered
  • Will Novartis be able to overcome regulators’ concerns with respect to its 5-HT4 agonist Zelnorm (tegaserod)?
  • What clinical advantages might Rottapharm’s novel cholecystokinin (CCK-1) have in the IBS treatment market?
  • To what degree will Schering Plough/ Centocor’s golimumab be affected if other anti-TNF products (Abbott’s Humira and Celltech’s Cimzia) reach the market first?
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)
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