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MonoSol Rx Completes Thin Film Escitalopram Oxalate Pilot Product Development
Date:8/4/2008

WARREN, N.J., Aug. 4 /PRNewswire/ -- MonoSol Rx, a specialty pharmaceutical company leveraging its proprietary drug delivery technology to develop thin film pharmaceutical products, today announced the completion of pilot product development for its thin film formulation of escitalopram oxalate, a selective serotonin reuptake inhibitor. Escitalopram oxalate is indicated for depression and generalized anxiety disorders and is marketed under the brand name Lexapro(R). Lexapro generated sales of $2.1 billion in 2007.

Based on product development results, the Company is preparing to initiate bioequivalence trials to support marketing submissions in the US and Europe.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "Our completion of prototype development has advanced our thin film escitalopram oxalate product to the clinical investigation stage of the project. Our proprietary PharmFilm(R) technology delivers thin-film drug products designed to offer significant patient benefits over other currently marketed prescription drug products and will help ensure that patients receive the appropriate dose in all treatment settings.

The Company is currently exploring potential partnerships to market their thin film formulation of escitalopram oxalate and expects to solidify an agreement prior to global regulatory submissions. The PharmFilm(R) escitalopram oxalate product should be available for marketing ahead of generic entrants expected in 2012, when Lexapro(R) loses patent exclusivity in the United States.

Keith Kendall, chief financial officer for MonoSol Rx, commented, "Our thin film formulation of escitalopram oxalate is one of the Company's self- funded initiatives designed to capitalize on our capacity to develop and manufacture thin film prescription products at commercial scale for a large pharmaceutical partner. As blockbuster drugs lose exclusivity, pharmaceutical companies are exploring alternative dosi
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