MonoSol Rx, LLC completes thin film ondansetron pilot bioequivalence study
WARREN, N.J. (Feb. 21, 2008) –MonoSol Rx, a drug delivery company specializing in dissolving thin film pharmaceutical products, today announced that it has successfully completed a pilot clinical study for its thin film formulation of ondansetron, a selective 5-HT3 receptor antagonist used in the prevention and treatment of nausea and vomiting.
MonoSol Rx’s thin film formulation of ondansetron was studied against GlaxoSmithKline’s Zofran ODT® product. Based on the results of the study, MonoSol Rx is moving immediately to pivotal trials to enable drug submissions both in the US and Europe. The Company expects to file with the appropriate regulatory authorities in 2008.
A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, “Successful completion of this pilot study marks an important step towards commercializing what we believe is a product with significant benefits over existing formulations of ondansetron. Our thin film formulation of ondansetron is particularly well suited for the target patient population because individuals who are prescribed the drug often have difficulty swallowing due to extreme nausea caused by chemotherapy, radiotherapy and surgical procedures. Incorporating ondansetron into a great-tasting thin film formulation that dissolves quickly in the mouth allows the drug to be easily administered without water, making it more palatable and less likely to cause additional discomfort.”
MonoSol Rx’s formulation of ondansetron is a new oral formulation expected to be introduced to the market next year. Its indications are the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV), prevention of nausea and vomiting associated with radiotherapy, and prevention of Post-Operative Nausea and Vomiting (PONV).
MonoSol Rx’s thin film technology utilizes strategic and proprietary intellectual property that ensures predictable in-vivo performance and provides superior characteristics over other delivery forms including competing film products. MonoSol Rx’s intellectual property includes thin film producing polymers, drug taste masking, processes that ensure product and content uniformity at scale, novel packaging and in-process testing methods.
Mr. Schobel continued, “The strength of our pipeline and intellectually property, combined with the convenience and potential dosing benefits of our thin film technology, sets MonoSol Rx apart as an innovator in the drug delivery sector. As the pharmaceutical industry evolves and more blockbuster drugs transition to generic, MonoSol Rx’s objective is to leverage our thin film technology via partnerships and self-funded development initiatives to bring new products to market that enhance the effectiveness and market-appeal of already-approved compounds. We believe this strategy will enable MonoSol Rx to cement its leadership position in the thin film drug delivery market.”
MonoSol Rx has signed a term sheet and is in final negotiations with a partner to market its thin film formulations for ondansetron in 4 and 8 mg strengths. Negotiations are expected to conclude prior to global regulatory submissions.
Keith Kendall, chief financial officer for MonoSol Rx, commented, “Completing an agreement with a partner for our ondansetron formulation should further solidify the market potential of MonoSol Rx’s technology and continue to demonstrate our ability to develop and manufacture prescription thin film products at scale for our partners. This agreement would build upon the development and supply agreement that we signed with Adams Respiratory Therapeutics in March 2007 for another, as-yet-unnamed prescription product.”With an annual prescription market of $1.2 billion in the US and approx $100 million in the top-five European countries, ondansetron is recognized as the leading 5-HT3 antagonist used in the prevention and treatment of nausea and vomiting.
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.