MonoSol Rx to initiate pivotal trials for ondansetron thin film immediately
Warren, NJ and Portage, Ind. (June 17, 2008) – 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 because patients who are prescribed ondansetron often have difficulty swallowing due to extreme nausea caused by chemotherapy and radiation treatments. Following approval, ondansetron would be one of the first prescription drugs to come to market utilizing thin film drug delivery technology.”
John A. MacPhee, president of Strativa, said, “We are delighted to collaborate with MonoSol Rx and expand our pipeline of supportive care products. With two unique, yet complementary delivery systems of ondansetron in our portfolio, Zensana™ oral spray and the oral thin film, we are able to offer patients a better opportunity to find a product that meets their individual needs.”
Keith J. Kendall, executive vice president and CFO of MonoSol Rx, stated, “The financial components of this relationship demonstrate the value of MonoSol Rx’s intellectual property, expertise in thin film development and manufacturing as well as our ability to partner for the commercialization of innovative thin film products.”
About MonoSol Rx
MonoSol Rx is a drug delivery company specializing in proprietary, dissolving thin film pharmaceutical products. The Company’s thin film technology, which is similar in size, shape and thickness to a postage stamp, dissolves rapidly and utilizes a novel process and proprietary encapsulation compositions to mask the taste of the drug contained within the film. The Company’s thin film formulations offer significant patient benefits, including convenience, taste, and potentially greater efficacy. MonoSol Rx’s strategy is to develop and partner innovative thin film strip products in the prescription, generic and OTC pharmaceutical markets and to establish a leadership position in thin film drug delivery technology through continued development of its drug delivery technology and intellectual property portfolio. For additional information, please visit www.monosolrx.com.
About Strativa
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par’s financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.