Warren, NJ (April 9, 2009) – MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced the submission on April 7, 2009 of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the orally dissolving film strip (ODFS) formulation of ondansetron.
The NDA is supported by positive data from completed pivotal studies in which ondansetron ODFS demonstrated bioequivalence against GlaxoSmithKline’s Zofran ODT® anti-emetic product. The ondansetron ODFS product has been developed as an anti-emetic therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV), nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, “The submission of the NDA for our ondansetron orally dissolving film strip marks another key milestone for MonoSol Rx and our licensing partner, Strativa Pharmaceuticals. This sets the stage for a promising new therapy to combat nausea resulting from chemotherapy, radiotherapy and surgical procedures. For patients in need of anti-emetic drugs, such as ondansetron, the burden of ingesting a tablet or swallowing a liquid medication can be significant because it has a tendency to exacerbate the nausea. Our PharmFilm® technology offers the potential to improve the convenience and compliance of ondansetron by delivering the drug through a quick orally dissolving film strip that requires no water.”
In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to the ODFS formulation of ondansetron from MonoSol Rx. Under terms of the agreement, MonoSol Rx will receive pre-commercialization and sales-based milestone payments that could total $23.5 million, as well as payments for the purchase of product supply and royalties on net sales.
The anti-emetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in quick dissolving films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm® technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programs that will generate long-term value.
The Company’s commercialization strategy for all PharmFilm® products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).
About Strativa Pharmaceuticals
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa 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 commercialization 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