MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study,of Aquavan Injection in Patients Undergoing Bronchoscopy ( MINNEAPOLIS--(BUSINESS WIRE)--Mar 20 2...)

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MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study,of Aquavan Injection in Patients Undergoing Bronchoscopy

MINNEAPOLIS--(BUSINESS WIRE)--Mar 20, 2007 - MGI PHARMA, INC. (NASDAQ: MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan(R) (fospropofol disodium) Injection for sedation of patients undergoing bronchoscopy successfully met its primary endpoint of sedation success as well as all secondary endpoints. Among patients who received an initial bolus dose of 6.5 mg/kg of Aquavan, the sedation success rate was 88.7% compared to 27.5% of patients in the control arm (p less than 0.001). Results of this trial also indicate that the safety profile of the 6.5 mg/kg dose of Aquavan was predictable and similar to the safety profile of the control.

Data from the phase 3 bronchoscopy trial, together with the results from a phase 3 trial in patients undergoing colonoscopy and an open-label study in patients undergoing minor surgical procedures, will form the foundation of the Aquavan New Drug Application (NDA). MGI PHARMA plans to submit the Aquavan NDA to the U.S. Food and Drug Administration (FDA) early in the third quarter of 2007. As is consistent with standard medical practice, the three trials comprising the Aquavan pivotal program were conducted without monitored anesthesia care (MAC) sedation, and study drugs were administered by medical personnel as dictated by local investigative site guidelines.

"With more than 40 million procedures per year in the U.S. requiring moderate sedation, Aquavan may address a significant market opportunity," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "The results of this pivotal program, together with completed pharmacokinetic studies, indicate that Aquavan has a pharmacokinetic and pharmacodynamic profile which may facilitate achievement and maintenance of targeted, controlled sedation by proceduralists. This unique profile may allow pati
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( MINNEAPOLIS--(BUSINESS WIRE)--Mar 20 2...)MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study,of Aquavan Injection in Patients Undergoing Bronchoscopy,Health