MGI PHARMA, HELSINN ANNOUNCE POSITIVE DATA ON ALOXI

MGI Pharma and its partner Helsinn Healthcare have announced the successful completion of two Phase III trials of Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting. Both clinical trials successfully met the primary efficacy endpoint of complete response for the 24-hour time period following surgery for the selected dose of 0.075 mg. In addition, both trials achieved the secondary endpoints of complete response for the 48- and 72-hour time periods. The incidence, pattern and intensity of adverse events were similar among treatment groups.

The two randomized, multicenter trials were conducted to evaluate the safety and efficacy of three doses of Aloxi compared with placebo for the prevention of postoperative nausea and vomiting. Based on these results, the companies plan to submit a supplemental new drug application to the FDA during the first half of 2007. Aloxi is already approved for the prevention of acute nausea and vomiting and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

The co-primary endpoints of both trials were complete response, defined as no emesis or use of rescue medication, for the 24-hour and 24-to-72-hour time periods following surgery. According to the prospectively defined statistical analysis plan, achievement of the 24-hour endpoint determined a successful trial and allowed for the testing of the 24-to-72-hour endpoint. Secondary endpoints included complete control (defined as complete response and no more than mild nausea), number of emetic episodes and incidence and severity of nausea.