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Strativa Pharmaceuticals Acquires Commercialization Rights to Thin Film Formulation of Ondansetron From MonoSol Rx
Date:6/17/2008

Second Unique Formulation of Ondansetron in Portfolio

WOODCLIFF LAKE, N.J., June 17 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), and MonoSol Rx today announced that they have entered into an exclusive licensing agreement under which Strativa has acquired the commercialization rights in the United States and its territories to the thin film formulation of ondansetron from MonoSol Rx, a leader in oral thin film technology. Ondansetron thin film formulation is a new oral formulation in development for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.

Based on the results of a recently completed pilot bio-equivalency study, MonoSol Rx is moving immediately to pivotal trials to enable application for drug approval in the U.S. Subject to favorable results, it is anticipated that Strativa could file an NDA with the appropriate regulatory authorities within the next twelve months.

Specific terms were not disclosed, but the agreement calls for milestone payments prior to commercial launch, payments for product supply, royalties and additional sales-based milestones on net sales of the product. Total milestone payments could be as high as $23.5 million.

Anti-emetic therapies constitute one of the largest segments of the supportive care market in the U.S., with annual sales of over $1.6 billion in 2007. Ondansetron was the prescription leader in the category in 2007, with 2.7 million scripts written.

John A. MacPhee, president of Strativa, said, "We are delighted to collaborate
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SOURCE Par Pharmaceutical Companies, Inc.
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