MonoSol Rx and KemPharm to Develop Novel PharmFilm® Product for ADHD
KemPharm's KP106 to be First ADHD Therapy Targeted for Oral Film Drug Delivery
Warren, NJ (April 25, 2011) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, today announced that the Company has entered into a development and commercialization partnership with KemPharm, a biopharmaceutical company focused on the discovery and development of new, safer therapies for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), pain, and cardiovascular disease.
Under terms of the agreement, the companies will co-develop and commercialize KP106, KemPharm’s novel prodrug for the treatment of attention-deficit hyperactivity disorder (ADHD), utilizing MonoSol Rx’s PharmFilm® delivery platform. MonoSol Rx will have a significant financial stake in KP106, will be the exclusive manufacturer and be eligible for development milestone payments.
The drug development initiative will combine MonoSol Rx’s patent-protected pharmaceutical film technology with KemPharm’s unique ADHD compound to provide improved compliance, safety and tolerability profiles to ADHD sufferers. Phase 1 human clinical trial results demonstrated pharmacokinetics that predict a superior safety profile for KP106 as compared to Vyvanse®, a currently marketed amphetamine stimulant for ADHD. In addition, preclinical studies suggest that the prodrug properties of KP106 may offer unique abuse deterrent properties as compared with current amphetamine-based treatments for ADHD.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, “We are pleased to announce our partnership with KemPharm, and the opportunity to develop the first-ever ADHD drug delivered using PharmFilm®. Our PharmFilm® platform matches well with KP106 and will provide a patent protected, convenient and innovative alternative to other ADHD products on the market. Our dosage form, in conjunction with KemPharm’s KP106, has the potential to offer a safer, abuse-resistant and more effective treatment option for ADHD, which is particularly important given the concerns of patients, parents and caregivers regarding the risks associated with currently marketed ADHD drugs.”
Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm said, “Our expertise in developing novel ADHD treatments, coupled with MonoSol Rx’s PharmFilm® technology, presents an ideal partnership. Our goal is to provide a novel, best-in-class ADHD treatment option with the additional benefit of a first-in-class oral film delivery technology. Our areas of expertise are strengthened and complemented by MonoSol Rx’s development capability, intellectual property, regulatory experience, and track record in gaining approval for and launching PharmFilm®-based products.”
KP106, KemPharm’s lead prodrug candidate for the treatment of ADHD, is composed of d-amphetamine and a ligand. In clinical studies, KP106 demonstrated pharmacokinetics indicative of an attenuated amphetamine exposure as compared to Vyvanse®. These data suggest that patients receiving KP106 may experience decreased side effects and decreased risk of abuse typically associated with stimulants. In addition, KemPharm is positioning KP106 to be the first ever proprietary thin film dosage form for ADHD. KemPharm projects the filing of a new drug application (NDA) for KP106 by the end of 2012.
About KemPharm, Inc.KemPharm, Inc. is focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable LAT prodrug approach. KemPharm utilizes its LAT prodrug technology to generate improved versions of FDA-approved drugs. Each NCE creates new composition-based intellectual property, may have a shorter development timeline and reduced development costs, and may be eligible for 505(b)(2) regulatory submission. The Company’s business strategy includes seeking strategic development partners following rapid clinical proof of concept demonstration in a Phase 1 trial. KemPharm also plans to explore discovery stage alliances with industry leaders, leveraging its prodrug know-how and LAT technology. KemPharm is developing candidates for ADHD, pain, other central nervous system disorders. www.kempharm.com
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in 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 film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence.
MonoSol Rx’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). For press releases and other company information visit www.monosolrx.com