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Schering/Zonagen end Vasomax agreement

Executive Summary

Schering-Plough and Zonagen mutually terminate worldwide licensing agreement for experimental oral erectile dysfunction therapy Vasomax and other phentolamine-based technologies, Zonagen announces July 15. The decision coincides with the submission of final results from a one-year mechanistic study of phentolamine-induced brown fat proliferations in rats, which Zonegan maintains show no effect. The study was designed to allay FDA's concerns raised by an earlier two-year rat carcinogenicity trial; FDA deemed Vasomax "not approvable" in May 1999 and subsequently placed the drug on clinical hold (1"The Pink Sheet" Aug. 16, 1999, p. 32)...

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Zonagen/Schering-Plough Vasomax

FDA places hold on clinical trials of Vasomax (phentolamine) pending analysis of data from a two-year rat carcinogenicity study, expected to be completed in the fourth quarter. Preliminary findings show a high proliferation of "brown fat" in the rats. A fully enrolled, 12-week Schering study of Vasomax for erectile dysfunction has been permitted to continue. Another proposed 12-week Schering study and a Zonagen Phase II trial of phentolamine for female sexual dysfunction are being placed on hold. The companies anticipate the hold will cause a six-month delay in regulatory filing

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