MGI Pharma MOGN New patents, anti cancer Message Board

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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer

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From: tom pope	12/14/2006 9:36:54 AM
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Merrill: Aloxi in PONV positive, but small opportunity Two phase 3 trials of Aloxi for the treatment of post-operative nausea and vomiting (PONV) reported positive data for the prevention of nausea and vomiting at 24 hours post-surgery (primary endpoint) and 48 & 72 hours post surgery (secondary endpoints). We estimate that a label expansion for PONV could boost Aloxi sales by $25 MM - $50 MM. But, because the Aloxi dose for PONV is 70% lower than that used for chemotherapy-induced nausea and vomiting (CINV) and because persistent nausea & vomiting is less common post-surgically than postchemo, we do not expect sales for PONV to significantly expand Aloxi’s market. Positive data on acute and persistent PONV Data from the two phase 3 trials of 0.075 mg Aloxi in PONV met the primary and secondary efficacy endpoints, but the company did not release specific response rate data. MGI and partner Helsinn conducted two randomized phase 3 trials, with a total of 1219 patients, to test the prevention of PONV in patients undergoing elective outpatient abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological or breast surgery (Study PALO- 04-07). Patients received IV Aloxi or placebo prior to administration of anesthesia and surgery. Safety data indicated that the adverse events were similar among treatment groups, with headache and constipation the most common. sNDA planned for 1H 2007 Based on the positive data for Aloxi in PONV, MGI And partner Helsinn expect to submit a sNDA to FDA in 1H 2007. Aloxi is already approved for use in CINV at a higher dose (0.25 mg for CINV vs 0.075 mg for PONV), so we expect approval in 1H08 following a standard 10 month review period. Broader label could modestly increase hospital/clinic use… We do not expect Aloxi approval in PONV to significantly increase sales of the drug. However, the approval of Aloxi in PONV in 1H 2008 could modestly help sales of the drug due to a broader label and ability for hospitals and clinics to keep stock of the drug for two purposes – CINV and PONV. …But, price may be more of a factor for PONV Acute nausea and vomiting is more common and more of a problem than persistent nausea and vomiting following surgery compared to chemotherapy in which persistent nausea and vomiting is very common. As a result, hospitals & clinics may be more inclined to continue to use drugs including Zofran or its generics (as well as other anti-emetics), which will be significantly less expensive than Aloxi, to prevent the acute nausea that is typical post-surgically.

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