KemPharm, Inc. announced that it has received a Notice of Issuance from the United States Patent and Trademark Office (USPTO) for its patent application entitled “Non-Standard Amino Acid Conjugates of Amphetamine and Processes for Making and Using the Same”, US Patent No. 7,776,917 B2.
This patent, combined with KemPharm’s recently issued US Patent No. 7,772,222, provides broad protection of the company’s Ligand Activated Therapy (LAT) prodrug technology platform and its application to the treatment of Attention Deficit – Hyperactivity Disorder. The patent covers 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.
“This second Notice of Issuance within a week of our first patent, reinforces our strong intellectual property position covering KP106 and other potential ADHD drugs derived from our LAT technology,” stated Travis Mickle, Ph.D., president & CSO for KemPharm. “Our prodrug platform continues to deliver on all fronts in ADHD as well as other indications, and we are excited to secure the necessary protection that will allow us to fully develop and commercialize our discoveries.”
“We have placed patent protection as a strategic priority from the inception of every program, so it is great to see that our efforts are being rewarded,” added Sven Guenther, Ph.D., vice president of Research. “The nature of LAT can lend itself to generating a wide range of prodrugs with diverse pharmacological and physicochemical properties that represent distinct and non-obvious changes from the parent drugs. These unique attributes enable us to pursue and receive protection from the USPTO.”
KP106, KemPharm’s lead prodrug candidate for the treatment of ADHD, is composed of damphetamine 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 forecast 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 paediatric patient population. KemPharm projects the filing of a new drug application (NDA) for KP106 by the end of 2012.
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.