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Diatide NeoTect Future Indications Will Be Evaluated Off-Label

This article was originally published in The Gray Sheet

Executive Summary

Diatide says that a $2 mil. milestone payment from marketing partner Nycomed Amersham triggered by FDA's Aug. 3 approval of NeoTect will be used in part to bolster its own marketing efforts for the lung cancer imaging agent.

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Nycomed Amersham's Sonazoid

New drug application is submitted for the ultrasound contrast agent. Based on results with 1,300 patients in Europe and the U.S., the NDA includes clinical data "demonstrating echocardiographic improvement in endocardial border delineation and left ventricular opacification following administration" of the drug, the firm says Aug. 6. On Aug. 3, FDA approved Diatide's NDA for the lung cancer detection agent NeoTect, which Nycomed Amersham is co-promoting in the U.S. (1see related story, p. 10)

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