MGI Pharma Inc. said Monday that a Food and DrugAdministration advisory committee's decision last week not torecommend approval of U.S. Bioscience Inc.'s chemoprotectiveEthyol product doesn't affect its own chemoprotective drug.
Shares of the Minneapolis company (NASDAQ:MOGN) rose 50cents to $19.75.
The committee did not reject the concept of chemoprotectives,said Kenneth Tempero, MGI chairman and CEO. "Thecommittee's recommendations and comments have reassuredme that our approach to study design, requiring substantialpatient populations for an NDA, is more in line with FDAexpectations."
MGI 136 is in Phase III trials of its ability to reduce thetoxicity of cisplatin and to stimulate bone marrow.
Hanifen, Imhoff analyst Robert Peterson said U.S. Bioscience'sproblems do not affect his assessment of MGI 136 because hesees significant side-effect problems with MGI 136. "The onlydata I have seen on it show it causes a lot of psychotherapeuticeffects, such as hallucination, dread and apprehension," he said.-- KH
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