KemPharm and MonoSol Rx to co-develop and commercialize novel ADHD prodrug

KemPharm’s KP106 poised to be first ADHD therapy targeted for oral film drug delivery, using MonoSol’s PharmFilm delivery platform

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NORTH LIBERTY, Iowa & WARREN, N.J.—KemPharm Inc. and MonoSol Rx LLC have entered into a development and commercialization partnership for KP106, KemPharm's clinical candidate for Attention Deficit/Hyperactivity Disorder (ADHD), using MonoSol's PharmFilm drug delivery technology.

The drug development initiative will, the companies say, 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. 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 seem to predict a superior safety profile for KP106 over Vyvanse, one of the current amphetamine stimulant drugs for ADHD treatment on the market.

Also, earlier preclinical studies suggested that the prodrug properties of KP106 may offer unique abuse deterrent properties as compared with current amphetamine-based treatments 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 deal, MonoSol has acquired the exclusive manufacturing rights for KP106, taking on the bulk of the formulation costs and the manufacturing costs through commercial launch in return for a right to receive a share of any royalties or other value associated with KP106. KemPharm will retain controlling ownership of the commercial rights for KP106.

As for intellectual property rights created during the development program, those will be shared by both companies.

"Our PharmFilm platform matches well with KP106 and will provide a patent protected, convenient and innovative alternative to other ADHD products on the market," says A. Mark Schobel, president and CEO of MonoSol. "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."

"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," asserts Dr. Travis Mickle, president and CEO of KemPharm. "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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