MonoSol Rx to initiate pivotal trials for ondansetron thin film immediately
WARREN, N.J. and PORTAGE, Ind., June 17 /PRNewswire/ -- MonoSol Rx, a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announced today that they have entered into an exclusive licensing agreement under which Strativa has acquired the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx. The 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 initiating pivotal trials immediately 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.
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 purchase of product supply and royalties on net sales.
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.
A. Mark Schobel, president and CEO of MonoSol Rx, stated, "We are very
excited about the collaboration with Strativa. They are uniquely positioned
to market and sell our ondansetron thin film product given their focus on
marketing novel prescription drugs. Thin film is particularly well suited
for this indication
|SOURCE MonoSol Rx|
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