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Palatin To Seek LeuTech BLA Expedited Review For Appendicitis Detection

This article was originally published in The Gray Sheet

Executive Summary

Palatin Technologies is targeting this summer for submission of a biologics license application for its LeuTech infection imaging agent for detecting appendicitis in patients with equivocal or suspected appendicitis. Phase III trials were completed in March.

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Mallinckrodt's 500-rep sales force will market the radiolabeled monoclonal antibody imaging agent for infection diagnosis, the firms say Aug. 17. St. Louis-based Palatin will receive a $500,000 licensing fee and a $10 mil. milestone payment upon FDA approval, as well as allow a $13 mil. stock purchase by Mallinckrodt. Phase III trials for LeuTech to assist diagnosis of equivocal appendicitis have been completed and the company anticipates filing a biologic license application in September (1"The Gray Sheet" May 3, p. 18)

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