Novartis' eagerly-anticipated entrant into the COX-2 inhibitor sector,Prexige (lumiracoxib/COX189), was the subject of three studies at the Digestive Diseases Week meeting in San Francisco, USA, providing early hints of the profile of a drug which is tipped to become a blockbuster by 2006.
Analysts at Julius Baer in Switzerland believe that Prexige is a key product for Novartis, particularly for the company's medium-term growth. To achieve its potential in a sector where there are already four strong competitors (Pharmacia's celecoxib, valdecoxib and parecoxib, as well as Merck & Co's rofecoxib), an efficacy advantage will be crucial, say the analysts.
However, the trial results presented at the DDW meeting, which included data from a 13-week study in 1,042 osteoarthritis patients, found that long-term use of therapeutic doses of Prexige showed a significantly lower rate of gastroduodenal ulcers than observed with the commonly-used nonsteroidal anti-inflammatory drug ibuprofen, but a similar rate to celecoxib. In a second study looking at effects on the gastroduodenum, Prexige was significantly better than naproxen, another NSAID, while a third study showed that Novartis' drug spared gastric mucosal prostaglandin synthesis compared to naproxen and caused little or no acute mucosal injury.
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