Ulcer Therapy Market Set For Transformation

The $5 billion peptic ulcer market is set for a major transformation as eradication of Helicobacter pylori infection takes precedence over maintenance treatment with H2 receptor antagonists and proton pump inhibitors. However, this is unlikely to occur overnight.

On December 13, a US Food and Drug Administration advisory committee paved the way for this shift by recommending the approval of two regimens for H pylori eradication; Glaxo Wellcome's Tritec (ranitidine bismuth citrate) in combination with Abbott's Biaxin (clarithromycin; it declined to back Tritec plus amoxicillin citing lack of efficacy), and Astra Merck's Prilosec (omeprazole) with clarithromycin, giving a further seal of approval to this approach to ulcer disease. It is suspected that there is already off-label use of these drugs for H pylori eradication, since the US National Institutes of Health published recommendations in February 1994 that all ulcer patients should receive antibiotics as part of their treatment (Marketletter February 14, 1994).

Astra appears to be leading the race in getting world approvals for its omeprazole-based regimen, (with over 20 countries in the bag) but GW is now catching up as its roll-out for Tritec gathers speed. The product was first launched for eradication in the UK earlier this year, and is currently being reviewed under the mutual recognition process in Europe.