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

ormulation is bioequivalent to the FDA approved Zofran ODT(R) product in all human clinical trials. Looking ahead, we are now working diligently with Strativa to complete and file the NDA with the FDA in early to mid-2009."

Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.8 billion in 2007 at a prescription drug price. Ondansetron was a prescription leader in the category in 2007, with 2.7 million scripts written. MonoSol Rx's thin film formulation of ondansetron was studied against GlaxoSmithKline's Zofran ODT(R) product.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films. PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that enable the funding of prescription product development programs that will generate long-term value.

The Company's commercialization strategy for all PharmFilm(R) products is to partner with the innovator or other specialty pharma or leading consumer products companies who have the core competency to sell-in and manage the sales and marketing of the products. For the Company's existing and future partners, PharmFilm(R) formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is also a tool to help sale
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