Warren, NJ (Aug. 4, 2008) – MonoSol Rx, a specialty pharmaceutical company leveraging its proprietary drug delivery technology to develop thin film pharmaceutical products, today announced the completion of pilot product development for its thin film formulation of escitalopram oxalate, a selective serotonin reuptake inhibitor. Escitalopram oxalate is indicated for depression and generalized anxiety disorders and is marketed under the brand name Lexapro®. Lexapro generated sales of $2.1 billion in 2007.
Based on product development results, the Company is preparing to initiate bioequivalence trials to support marketing submissions in the US and Europe.
A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, “Our completion of prototype development has advanced our thin film escitalopram oxalate product to the clinical investigation stage of the project. Our proprietary PharmFilm® technology delivers thin-film drug products designed to offer significant patient benefits over other currently marketed prescription drug products and will help ensure that patients receive the appropriate dose in all treatment settings.”
The Company is currently exploring potential partnerships to market their thin film formulation of escitalopram oxalate and expects to solidify an agreement prior to global regulatory submissions. The PharmFilm® escitalopram oxalate product should be available for marketing ahead of generic entrants expected in 2012, when Lexapro® loses patent exclusivity in the United States.
Keith Kendall, chief financial officer for MonoSol Rx, commented, “Our thin film formulation of escitalopram oxalate is one of the Company’s self-funded initiatives designed to capitalize on our capacity to develop and manufacture thin film prescription products at commercial scale for a large pharmaceutical partner. As blockbuster drugs lose exclusivity, pharmaceutical companies are exploring alternative dosing formulations as differentiators from generic entrants. We also believe that our PharmFilm® technology offers an attractive opportunity to extend product revenue life-cycles. The validity of our technology has been established by our over the counter drug product introductions and other prescription pharmaceutical partnerships, including the recently announced licensing of our thin film formulation of ondansetron, an anti-emetic therapy, to Strativa Pharmaceuticals, a divison of Par Pharmaceuticals. Our expectation is to partner our PharmFilm® escitalopram oxalate product with a pharmaceutical company that is competitively positioned in this market.”
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 currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its 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 enable the funding of prescription product development programs that will generate long-term value.
The Company’s commecialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma or leading consumer products companies who have the core competency to sell-in and manage the sales and marketing of the products. For the Company’s 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 ODTs.
PharmFilm® is a proprietary drug delivery technology that utilizes a novel process and encapsulation compositions to develop easy to use, taste-masked, quick dissolving thin-film drug formulations. PharmFilm® delivers a convenient efficacious dose of drug that in some instances can deliver improved therapeutics. PharmFilm’s drug delivery advantages significantly benefits patients and their prescribing physicians, and helps improve compliance in pediatric, elderly and other patients who have difficulty swallowing traditional dosage forms.