Navigation Links
MonoSol Rx and KemPharm to Develop Novel PharmFilm® Product for ADHD
Date:4/25/2011

WARREN, N.J., April 25, 2011 /PRNewswire/ -- 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."

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 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 thin film dosage form for ADHD.  KemPharm projects the filing of a new drug application (NDA) for KP106 by the end of 2012.

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.  Each NCE creates new composition-based intellectual property, may have a shorter development timeline and reduced development costs, and may be eligible for 505(b)(2) regulatory submission.  The Company'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, other central nervous system disorders.  www.kempharm.com

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 and over-the-counter (OTC) 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.  

MonoSol Rx's commercialization strategy for all PharmFilm® products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing.  For existing and future partners, PharmFilm® formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.  PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).  For press releases and other company information visit www.monosolrx.com.

Contacts:

MonoSol Rx:
Keith Kendall
Chief Financial Officer
(732) 564-5000

The Ruth Group (on behalf of MonoSol Rx)
Jason Rando/Eric Reiss (media)
(646) 536-7025/7032
jrando@theruthgroup.com / ereiss@theruthgroup.com  

Joshua Drumm (investors)
(646) 536-7006
jdrumm@theruthgroup.com


'/>"/>
SOURCE MonoSol Rx
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study
2. MonoSol Rx Completes Thin Film Escitalopram Oxalate Pilot Product Development
3. MonoSol Rx Issued Strategic U.S. Patent Governing the Manufacturing of Pharmaceutical Films
4. MonoSol Rx, LLC Files Patent Infringement and False Marking Lawsuit Against BioDelivery Sciences International, Inc., MEDA Pharmaceuticals Inc., and Aveva Drug Delivery Systems, Inc.
5. MonoSol Rx, LLC Announces Suboxone Sublingual Film Achieves 25% Share of Total U.S. Suboxone Market Volume at Year-End 2010
6. MonoSol Rx Secures 505(b)(2) Regulatory Pathway for Montelukast Sodium Oral Soluble Film
7. MonoSol Rx Issued Strategic US Patent Governing the Production of Pharmaceutical Films Containing Specific Drugs and Drug Classes
8. KemPharm, Inc. Receives Notice of Issuance From USPTO on Patent Protecting Companys ADHD Prodrug Technology
9. KemPharm, Inc. Receives Notice of Issuance from USPTO on Second Patent Protecting Companys ADHD Prodrug Technology
10. KemPharm, Inc. Announces Plans to Launch KP106 as First Oral Film Dosage Form for ADHD
11. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... , Feb. 11, 2016  Walgreens has committed to ... states and Washington, D.C. as part ... that was commended by shareholder advocacy organization As You Sow. ... You Sow. "Many people hold on to unneeded drugs because ... have tragic consequences." --> Conrad MacKerron , ...
(Date:2/11/2016)... 11, 2016   Health 2.0 , the premiere ... technologies, announced today " 10 Year Global Retrospective ", ... over the past ten years.   ... Health 2.0 has served as the preeminent thought-leader in ... thousands of technologies, companies, innovators, and patient-activists through an ...
(Date:2/11/2016)...  NOIT™ Research LLC, a private, leading-edge autism research ... to assist needy families in obtaining one of its ... February 10, 2016 and March 31, 2016, the company ... NOIT is an auditory stimulus that plays a key ... Beth Shier , NOIT Research director. ...
Breaking Medicine Technology:
(Date:2/12/2016)... Malvern, Pa. (PRWEB) , ... February 12, 2016 ... ... help sort through a world of exterior design possibilities. CertainTeed, North America’s leading ... visualization tools by expanding the product offerings showcased in the mobile version of ...
(Date:2/12/2016)... ... February 12, 2016 , ... Healthcare careers in the medical laboratory, ... jobs via the website of healthcare staffing leader Aureus Medical Group during the month ... , travel therapy positions and in travel and direct hire opportunities in ...
(Date:2/12/2016)... ... 2016 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh ... says are the real facts surrounding all those Bible stories. For generations families have ... teachers, and Yisrayl says there is more to these than just mere “stories”. ...
(Date:2/12/2016)... ... February 12, 2016 , ... With the exception of restorative dentistry, to date there ... With the recent approval by the FDA, there is a now a new protocol ... varnish, SDF is very simple and quick to apply. The application is as simple ...
(Date:2/11/2016)... ... ... “ HEALING MIND : Five Steps to Ultimate Healing, Four Rooms for ... readers how to become their own therapist. Providing a useful step-by-step process for achieving ... an understanding of how to heal one’s inner child using four archetypes of Christianity. ...
Breaking Medicine News(10 mins):