Low Levels of Diagnosis and New Biological Approaches to Treatment Indicate a Positive Future for Gastrointestinal Drugs

Business Wire, June 18, 2008

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/e40571/gastrointestinal_d) has announced the addition of the "Gastrointestinal Drug Discoveries: What the Future Holds" report to their offering.

This new strategic report from Espicom provides a comprehensive review of current and future treatments for major gastrointestinal therapy areas: inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and gastro-oesophageal reflux disease (GORD).

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.

Executive Summary:

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

This report provides:

-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 include:

-Tumour necrosis factor alpha inhibitors

-Cell adhesion molecule inhibitors

-T-cell modulators

-Interleukin inhibitors

-Serotonergic agents

-H2 receptor antagonists

-Proton pump inhibitors

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?

Key Topics Covered:

- The IBD therapy market

- IBD management