KemPharm, Inc. announced that KP106, its clinical candidate for Attention Deficit/Hyperactivity Disorder (ADHD), will be formulated and developed in an oral film dosage form pursuant to an exclusive collaboration agreement with MonoSol Rx relating to the development, commercialization and manufacture of KP106.

KP106 is a new chemical entity (NCE) comprised of d-amphetamine, and was identified utilizing KemPharm’s proprietary ligand activated therapy (LAT) approach. 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.

Under the terms of the exclusive collaboration agreement, MonoSol Rx, the developer of PharmFilm technology and a drug delivery company specializing in rapid dissolving prescription film pharmaceutical products, has acquired the exclusive manufacturing rights for KP106. In exchange for these manufacturing rights and a right to receive a share of any royalties or other value associated with KP106, MonoSol Rx will be responsible for the majority of formulation costs and the manufacturing costs through commercial launch. KemPharm will retain controlling ownership of the commercial rights for KP106, while intellectual property rights created during the joint-development programme will be shared by both companies.

“We are enthusiastic about the synergies that will result from this collaboration. Due to its abuse deterrent properties combined with its compliance film dosage form to address issues plaguing existing pediatric pill dosage forms, KP106 is poised to become the next generation ADHD therapy,” commented Travis Mickle, Ph.D., president and chief executive officer, KemPharm.

“This collaboration is a natural strategic fit for MonoSol Rx and our PharmFilm technology,” commented A. Mark Schobel, president and chief executive officer, MonoSol Rx. “KemPharm is a true pharmaceutical innovator, and through the combination of KP106 and PharmFilm, there is the potential to introduce a novel ADHD product that could represent a safer, more convenient treatment option for ADHD patients. We look forward to working together to maximize the commercial potential of KP106 through this partnership.”

KP106, KemPharm’s lead prodrug candidate for the treatment of ADHD, is composed of damphetamine 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 oral film dosage form for ADHD. KemPharm projects the filing of a new drug application (NDA) for KP106 in 1H2013.

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.

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.