WARREN, N.J. and PORTAGE, Ind., June 17 MonoSol Rx, a drugdelivery company specializing in dissolving thin film pharmaceutical products,and Strativa Pharmaceuticals, the proprietary products division of a whollyowned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), announcedtoday that they have entered into an exclusive licensing agreement under whichStrativa has acquired the U.S. commercialization rights to the thin filmformulation of ondansetron from MonoSol Rx. The ondansetron thin filmformulation is a new oral formulation in development for the prevention ofchemotherapy-induced nausea and vomiting, prevention of nausea and vomitingassociated 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 fordrug approval in the U.S. Subject to favorable results, it is anticipatedthat Strativa could file an NDA with the appropriate regulatory authoritieswithin the next twelve months.
Under terms of the agreement, MonoSol Rx will receive milestone paymentsprior to commercial launch and sales-based milestones that could total $23.5million as well as payments for purchase of product supply and royalties onnet sales.
Anti-emetic therapies constitute one of the largest segments of thesupportive care market in the U.S., with annual sales of over $1.6 billion in2007. Ondansetron was the prescription leader in the category in 2007, with2.7 million scripts written.
A. Mark Schobel, president and CEO of MonoSol Rx, stated, "We are veryexcited about the collaboration with Strativa. They are uniquely positionedto market and sell our ondansetron thin film product given their focus onmarketing novel prescription drugs. Thin film is particularly well suited forthis indication because patients who are prescribed ondansetron often havedifficulty swallowing due to extreme nausea caused by chemotherapy andradiation treatments. Following approval, ondansetron would be one of thefirst prescription drugs to come to market utilizing thin film drug deliverytechnology."
John A. MacPhee, president of Strativa, said, "We are delighted tocollaborate with MonoSol Rx and expand our pipeline of supportive careproducts. With two unique, yet complementary delivery systems of ondansetronin our portfolio, Zensana(TM) oral spray and the oral thin film, we are ableto offer patients a better opportunity to find a product that meets theirindividual needs."
Keith J. Kendall, executive vice president and CFO of MonoSol Rx, stated,"The financial components of this relationship demonstrate the value ofMonoSol Rx's intellectual property, expertise in thin film development andmanufacturing as well as our ability to partner for the commercialization ofinnovative 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 filmtechnology, which is similar in size, shape and thickness to a postage stamp,dissolves rapidly and utilizes a novel process and proprietary encapsulationcompositions to mask the taste of the drug contained within the film. TheCompany's thin film formulations offer significant patient benefits, includingconvenience, taste, and potentially greater efficacy. MonoSol Rx's strategyis to develop and partner innovative thin film strip products in theprescription, generic and OTC pharmaceutical markets and to establish aleadership position in thin film drug delivery technology through continueddevelopment of its drug delivery technology and intellectual propertyportfolio. For additional information, please visit www.monosolrx.com.
Strativa Pharmaceuticals is the proprietary products division of ParPharmaceutical, Inc. Supported