KemPharm to launch oral film dosage form for ADHD

The company has entered into a collaboration with MonoSol Rx to co-develop and commercialise KP106

KemPharm Inc’s clinical candidate for Attention Deficit/Hyperactivity Disorder, KP106, will be formulated and developed in an oral film dosage form following an exclusive collaboration agreement with MonoSol Rx relating to its development, commercialisation and manufacture.

KP106 is a new chemical entity (NCE) comprised of d-amphetamine, and was identified utilising 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 abuse deterrent properties as compared with current amphetamine-based treatments for ADHD.

MonoSol Rx’s proprietary PharmFilm technology delivers drugs in films. Under the terms of the exclusive collaboration agreement, the drug delivery company 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 paediatric pill dosage forms, KP106 is poised to become the next generation ADHD therapy,’ said Travis Mickle, president and ceo, KemPharm.

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