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 Scientific 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."
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