MonoSol Rx Announces Second PharmFilm® Product for ADHD

Expands Collaboration with KemPharm with Recently Discovered KP415

Warren, NJ (August 30, 2011) – MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, today announced that the Company plans to develop a second oral film product for the treatment of attention-deficit hyperactivity disorder (ADHD) with its partner KemPharm, Inc. (“KemPharm”), a biopharmaceutical company focused on the discovery and development of new, safer therapies for the treatment of ADHD, pain, and other central nervous system disorders.  KP415, which was recently discovered by KemPharm, is a novel prodrug of methylphenidate, a commonly used medication for the treatment of ADHD.

The companies plan to co-develop the oral film dosage form of KP415 under a previously established exclusive technology and manufacturing partnership, which also currently includes KP106, a prodrug of d-amphetamine.  If approved, these drug candidates will be the first oral film products for the treatment of ADHD, which consists primarily of a pediatric patient population.

A. Mark Schobel, Co-President and Chief Executive Officer of MonoSol Rx, stated, “The addition of KP415 to our partnership with KemPharm provides us with a portfolio of highly differentiated products for treating ADHD.  We believe delivery of KP415 and KP106, using our patented PharmFilm technology, significantly improves the convenience with which these novel molecules, which represent two major classes of drugs used to treat ADHD, can be dosed. This may improve patient compliance and therapeutic outcomes.  We look forward to working closely with KemPharm to advance these programs and to commercializing the first ADHD treatments using oral film drug delivery.”

Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm said, “We share our enthusiasm about the discovery of KP415 with our partners at MonoSol Rx.  Along with KP106, our diversified, next-generation ADHD portfolio has the potential to change the way this disorder is treated by creating novel prodrugs with the potential to improve upon existing therapies in clinically meaningful ways.”

Under terms of the agreement, the companies will co-develop and commercialize KemPharm’s KP415 and KP106 utilizing MonoSol Rx’s PharmFilm delivery platform.  MonoSol Rx will be the exclusive manufacturer and be eligible for development milestone payments.

About KP415

KP415, KemPharm’s preclinical candidate for the treatment of ADHD, is composed of methylphenidate and a ligand.  In preclinical studies, KP415 demonstrated an improved pharmacokinetic profile, with the potential to lower the therapeutic dose of methylphenidate and possibly reduce the side effects consistent with stimulants such as loss of appetite and insomnia.  Additionally, KemPharm has filed a provisional patent application covering key aspects of KP415.

About KP106

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 attenuated amphetamine exposure as compared to Vyvanse®.  These data suggest that patients receiving KP106 may experience decreased side effects and that KP106 may reduce the potential for 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.

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 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 combination sublingual film product for the treatment of opioid dependence.

For press releases and other company information visit www.monosolrx.com

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. KemPharm’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 and other central nervous system disorders. www.kempharm.com

Please complete this form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing info@aquestive.com or by calling 1-908-561-1900.

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

  • To subscribe to receive marketing updates about diazepam buccal film and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form to receive a demonstration kit for our PharmFilm® technology.

  • To subscribe to receive marketing updates about our PharmFilm® technology and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”