KemPharm, Inc. Receives Notice of Issuance From USPTO on Patent Protecting Company's ADHD Prodrug Technology

NORTH LIBERTY, Iowa, Aug. 16 /PRNewswire/ -- KemPharm, Inc. announced today that it has received a Notice of Issuance from the United States Patent and Trademark Office (USPTO) for its patent application entitled "Polar Hydrophilic Prodrugs of Amphetamine and Other Stimulants and Processes for Making and Using the Same", U.S. Patent No. 7,772,222.  This patent protects broad aspects of the Company's core Ligand Activated Therapy (LAT) prodrug technology platform and its application to the treatment of Attention Deficit – Hyperactivity Disorder.  The patent includes key related compounds to the Company's lead clinical candidate KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, which recently successfully completed a Phase 1 clinical trial.  

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"This Notice of Issuance signals a major accomplishment for KemPharm as it marks the first issued patent protecting compounds related to KP106 and other ADHD drugs derived from our LAT platform," stated Travis Mickle, Ph.D., President & CSO for KemPharm.  "Obtaining this patent within four years of founding KemPharm validates our efficient approach to securing intellectual property and highlights the value of our proprietary LAT technology.  This is the first of what we anticipate to be many patents we expect to have issued that protect our products under development covering various CNS indications."  

"Intellectual property is an important strategic focus for a prodrug company like KemPharm," added Sven Guenther, Ph.D., Vice President of Research.  "Since most of our programs are designed to improve already marketed drugs, we pay particular attention to how we can differentiate our products from potential prior art before we ever synthesize a molecule utilizing LAT.  We are pleased that the USPTO has acknowledged the novel aspects and non-obvious results generated by our ADHD portfolio and granted protection of our discoveries."

About KP106

KP106, KemPharm's lead prodrug candidate for the treatment of ADHD, is composed of d-amphetamine and a ligand.  In preclinical studies, KP106 demonstrated unique abuse deterrent properties along with pharmacokinetics indicative of an attenuated amphetamine exposure as compared to Vyvanse®.  These data predict that patients receiving KP106 may experience decreased side effects and decreased risk of abuse typically associated with stimulants.  Importantly, KemPharm is positioning KP106 to be the first ever proprietary thin film dosage form for ADHD to address compliance issues, in particular, for the pediatric patient population.  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 platform.  KemPharm is developing candidates for ADHD, pain, other central nervous system disorders, cardiovascular disease and cancer.  www.kempharm.com

Forward Looking Statements and Information

This release contains forward-looking statements which are not based upon historical fact, including, without limitation, "will," "should," "expect," "anticipate," "plan," "predict," "believe," "may" and "project."  Such statements, including statements relating to developments, progress, timelines, plans of our clinical and preclinical programs, and potential benefits of KemPharm Inc.'s product candidates, involve various assumptions, known and unknown risks, and uncertainties which may cause actual results or events to be materially different and adverse from those expressed in or implied by the forward-looking statements.  Such assumptions, risks and uncertainties may relate to difficulties or delays in discovery, development, testing, and regulatory approval of the company's product candidates, results that are inconsistent with preclinical results, unexpected adverse side effects, or inadequate therapeutic efficacy of the product candidates.  The forward-looking statements in this release speak only as of this date, and KemPharm disclaims any obligation to update publicly any forward-looking statement to reflect the occurrence of events or circumstances after the date hereof.

Contacts:

KemPharm, Inc.

Kate Holt, Ph.D.

319-665-2575

E-mail: info@kempharm.com



SOURCE KemPharm, Inc.



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