Novartis claims Prexige safety advantage over rivals
pharmafile | August 26, 2004 | News story | |
Novartis is preparing its latest blockbuster candidate Prexige for launch around the world by proclaiming its superior side-effect profile to existing treatments, including Cox-II's Celebrex and Vioxx.
The company claims new data shows the arthritis and pain treatment is the first Cox-II inhibitor to significantly reduce the incidence of gastrointestinal ulcer complications without compromising cardiovascular health – a key concern in the lucrative pain market.
The 18,325 osteoarthritis patient-TARGET (Therapeutic Arthritis Research and Gastrointestinal Event Trial) study, which compared Prexige (lumiracoxib) with two established NSAIDs (non-steroidal anti-inflammatory drugs), naproxen and ibuprofen, showed Novartis' drug produced 79% fewer upper GI ulcer complications and did not increase risk of cardiovascular complications.
Cox-II inhibitors are NSAIDs but were developed to match the efficacy of existing NSAIDs without gastrointestinal problems, but reports of adverse reactions have dampened these claims, with cardiovascular concerns slowing the growth of Merck's Vioxx and Pfizer's Celebrex.
Merck's drug in particular has suffered from post-marketing studies, one study showing patients on Vioxx experienced a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator NSAID. Meanwhile, a recent case-control study of 17,000 patients showed Vioxx had a relative risk for hypertension of 1.6 compared to its rival Celebrex.
Chris Hawkey, Professor of Gastroenterology and co-director of the Institute of Clinical Research, University of Nottingham and chairman of the GI committee during the TARGET trial said the study produced robust data which showed a four-fold reduction in ulcer complications compared to NSAIDs.
He concluded: "The benefit demonstrated by Prexige has not been shown by any other selective Cox-II inhibitor."
The study found no difference in myocardial infarctions, stroke or any cardiovascular endpoints of the trial, a significant finding which could help Prexige against the UK market leader Vioxx.
The data should help the drug gain FDA approval at the second time of asking, following its rejection in 2003. Despite the FDA's objections, the drug received UK approval 12 months ago, and the company is now pursuing mutual recognition across the EU.
"TARGET fully supports the approved label in the UK and builds a strong basis for the ongoing European Mutual Recognition Process (MRP), which was recently started," said Joerg Reinhardt, head of development, Novartis Pharma AG.
The FDA had requested the submission of the final report of the TARGET study, as well as additional clinical data for Prexige, before looking at granting marketing approval in the US for the indications of osteoarthritis and acute pain.
The positive trial results, and the fact that there are about 16,500 GI-related deaths in the US every year, should help this process which could see the drug launched their by 2005
The FDA's original rejection caused analysts Deutsche Bank to cut in half its forecast sales for the drug in 2007 from just over $1 billion to $500 million, representing around 5% of the Cox-II market.
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