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MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA
Date:12/2/2008

Expects to File NDA with FDA in Early to Mid-2009

WARREN, N.J.,Dec. 2 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced the successful completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron. The ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Subject to final review of the data and discussions with the Food and Drug Administration (FDA), it is anticipated that MonoSol Rx and Strativa could file a New Drug Application (NDA) in early to mid 2009.

In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for the purchase of product supply and royalties on net sales. The successful achievement of all pivotal bioequivalence studies triggered a milestone payment to MonoSol Rx.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "Completion of the pivotal bioequivalence trials is a significant milestone in the development and commercialization process for our thin film ondansetron formulation. Working with our licensing partner, Strativa Pharmaceuticals, we were able to demonstrate that our PharmFilm(R) f
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SOURCE MonoSol Rx
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