Palatin to submit LeuTech application

After a successful meeting with the Food and Drug Administration last month, biopharmaceutical firm Palatin Technologies got the go-ahead to file a biologics license application this summer for its monoclonal antibody infection imaging agent, LeuTech. The company met with the FDA’s Center for Biologic Evaluation and Research in Rockville, MD, and the agency reviewed Palatin’s phase III trial data for LeuTech for the diagnosis of equivocal appendicitis. Palatin hopes LeuTech will be available for sale by mid-summer 2000.

The FDA’s permission to proceed further enhances the Princeton, NJ, company’s R&D momentum, as it comes on the heels of the company’s May 17 announcement that it had signed a letter of intent for a marketing alliance with St. Louis-based Mallinckrodt (SCAN 5/26/99).

© 1999 Miller Freeman, Inc.All rights reserved.

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