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Based on product development results, the Company is preparing to initiatebioequivalence trials to support marketing submissions in the US and Europe.
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A. Mark Schobel, president and chief executive officer of MonoSol Rx,stated, "Our completion of prototype development has advanced our thin filmescitalopram oxalate product to the clinical investigation stage of theproject. Our proprietary PharmFilm(R) technology delivers thin-film drugproducts designed to offer significant patient benefits over other currentlymarketed prescription drug products and will help ensure that patients receivethe appropriate dose in all treatment settings.
The Company is currently exploring potential partnerships to market theirthin film formulation of escitalopram oxalate and expects to solidify anagreement prior to global regulatory submissions. The PharmFilm(R)escitalopram oxalate product should be available for marketing ahead ofgeneric entrants expected in 2012, when Lexapro(R) loses patent exclusivity inthe United States.
Keith Kendall, chief financial officer for MonoSol Rx, commented, "Ourthin film formulation of escitalopram oxalate is one of the Company's self-funded initiatives designed to capitalize on our capacity to develop andmanufacture thin film prescription products at commercial scale for a largepharmaceutical partner. As blockbuster drugs lose exclusivity, pharmaceuticalcompanies are exploring alternative dosing formulations as differentiatorsfrom generic entrants. We also believe that our PharmFilm(R) technology offersan attractive opportunity to extend product revenue life-cycles. The validityof our technology has been established by our over the counter drug productintroductions and other prescription pharmaceutical partnerships, includingthe recently announced licensing of our thin film formulation of ondansetron,an anti-emetic therapy, to Strativa Pharmaceuticals, a division of ParPharmaceuticals. Our expectation is to partner our PharmFilm(R) escitalopramoxalate product with a pharmaceutical company that is competitively positionedin this market."
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging itsproprietary PharmFilm(R) technology to deliver drugs in quick dissolvingfilms. PharmFilm(R) is designed to benefit patients by improving theconvenience, efficacy, and compliance of currently marketed drugs. The Companyis a leader in thin film drug delivery and has a strong intellectual propertyposition, a portfolio of commercialized OTC drug products, and a pipeline ofprescription formulations utilizing its PharmFilm(R) technology. With avertically integrated development and production infrastructure, MonoSol Rxhas the capacity to manufacture OTC drug products for near-term revenues thatenable the funding of prescription product development programs that willgenerate long-term value.
The Company's commercialization strategy for all PharmFilm(R) products isto partner with the innovator or other specialty pharma or leading consumerproducts companies who have the core competency to sell-in and manage thesales and marketing of the products. For the Company's existing and futurepartners, PharmFilm(R) formulations represent revenue-life cycle extensionsfor products with patent lives that have expired or are approachingexpiration. PharmFilm(R) is also a tool to help sales and marketing partnersdifferenti
