Forest Labs
Executive Summary
Licenses U.S. rights to fosfomycin trometamol, a single-dose antibiotic for uncomplicated urinary tract infections, from Italian firm Zambon Group. Forest will copromote and codevelop the product, which is delivered as a 3 gram sachet that is reconstituted with water. The agreement "is the first in a network of U.S. partnerships planned" by Zambon, the company said Nov. 20. Two-arm Phase III trials that are designed to enroll 600 evaluable patients total are "well-advanced" in the U.S., Forest says, with an NDA filing "planned by the end of 1992" under Zambon's name. Fosfomycin is marketed in eight countries as Monuril.