Forest Close To Filing For Monurol In USA?

Forest Laboratories is close to filing a New Drug Application for its antibiotic Monurol (fosfomycin trometamol), according to Jonathan Gelles of Wertheim Schroder, who believes that the product may be the company's next important new drug. Dr Gelles estimates that Monurol possesses the potential to become a $50 million-plus product, making it Forest's second-largest drug.

Forest licensed Monurol from Italy's Zambon Group in November 1991. The company became involved with the development of the product at the Phase III trials stage, which were started in 1993 by Zambon. If the product comes to market, Forest will sell Monurol using bulk product purchased from Zambon.

Convenient Dosing Monurol has already been approved for marketing in eleven countries, with its primary indication being the treatment of uncomplicated urinary tract infections. The advantage of the product lies in its one-tablet dosing regimen, noted Dr Gelles, who believes that Monurol will carve out a a favorable niche for itself in a relatively crowded sector.