MGI Pharma Reports Acceptance Of Aquavan NDA For Review By FDA - Update

(RTTNews) - Monday morning, biopharmaceutical company MGI Pharma Inc. (MOGN | charts | news | PowerRating) said it's New Drug Application or NDA for Aquavan or fospropofol disodium Injection was accepted for filing by the United States Food and Drug Administration or FDA. Under Prescription Drug User Fee Act or PDUFA III, the FDA's goal is to review and act on the NDA by July 26, 2008.

On September 27, MGI had submitted a NDA for Aquavan or fospropofol disodium Injection with the FDA for review. In its NDA, the company had included data from phase 2 and phase 3 trials in patients colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures. Overall, data from 21 clinical studies involving 1,611 patients were included in the NDA.

The company conducted a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan Injection for sedation in patients undergoing bronchoscopy, in which patients successfully met the primary endpoint of sedation success as well as all secondary endpoints.

MGI Pharma also conducted a randomized, double-blind, multi-center phase 3 pivotal trial to evaluate whether an Aquavan dosing regimen of 6.5 mg/kg would be safe and effective in providing moderate sedation in patients undergoing colonoscopy, compared to a control dose of 2.0 mg/kg. About 87% of the patients met the primary endpoint.

Further, an open label study conducted in patients undergoing a variety of minor surgical procedures showed that no adverse events led to procedure or study drug discontinuation.

MGI Pharma, on October 22 had announced the presentation of results of a successful randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan Injection in patients undergoing flexible bronchoscopy.

The primary endpoint of this trial was sedation success, defined as a patient having achieved three consecutive Modified Observer¡¯s Assessment of Alertness/Sedation or MOAA/S scores of ¡Ü4 after administration of sedative medication and completion of the bronchoscopy procedure without the use of alternative sedative medication and without manual or mechanical ventilation.

The secondary endpoint of treatment success was defined as completion of the procedure without the use of alternative sedative medication and without manual or mechanical ventilation. Additional endpoints included measures of patient and physician satisfaction.

Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing diagnostic or therapeutic procedures. It is a fospropofol disodium Injection, which is a proprietary water-soluble intravenous injection, rapidly converted by an enzyme in the body into propofol.

MGI Pharma, which has a market cap of $2.7 billion, is a component of S&P 600 small cap index. The company was founded in 1979 as Molecular Genetics, Inc. and changed its name to MGI Pharma, Inc. in 1990.

MOGN closed Friday's regular trading session at $40.31, up $0.10 on a volume of 3.69 million shares, higher than the three month average volume of 2.71 million shares.

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