Upper GI Disorders Generics will limit pipeline profit

Gastroesophageal reflux disease (GERD), functional dyspepsia (FD) and peptic ulcer disease (PUD) represent a group of common gastrointestinal (GI) conditions, which can be referred to collectively as upper GI disorders. Gastric acid suppression remains the cornerstone of therapy in upper GI disorders, with particular focus on reducing symptoms and eradicating H. pylori, if present.

Scope of this report

Analysis of patient potential, unmet needs and clinical trials in upper GI disorders.

Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the R&D pipeline.

Detailed profiles of key compounds in development for use in upper GI disorders, with forecasts of drug revenues to 2016.

Discussion of R&D company strategies used in upper GI disorder market, focusing on AstraZeneca and TAP Pharmaceuticals.

Research and analysis highlights

The upper GI disorder pipeline is small, with only 33 products, and only 3 drugs in Phase III. In a market that is dominated by PPIs, which are becoming increasingly genericized, and with over-the-counter medicines available, pharmaceutical companies appear to be less than willing to enter this competitive market.

A key company R&D strategy is the development of specific enantiomers of PPIs. This extends patent life and can result superiority to the racemate mixture. TAP Pharmaceuticals has for dexlansoprazole, and Sidem Pharma and Steba Laboratories are co-developing S-tenatoprazole for GERD. Both are expected to quickly achieve blockbuster status.

The inclusion of Nexium (esomeprazole) as a comparator in clinical trials is essential to ensure market success for pipeline products. Companies will also benefit by addressing the unmet needs such as drugs for the PPI unresponsive population. This niche patient subgroup is difficult to treat and is currently underserved.

Key reasons to read this report

Understand unmet needs in the upper GI disorder market based on key opinion leader comment.

Benchmark key late-stage pipeline products against the current market leader.

Assess the sales forecasts of key late-stage pipeline drugs and examine their clinical and commercial potential.

Published: 11 July 2007

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