KemPharm, Inc. Receives Additional Notice of Allowance for Novel Prodrugs of Hydrocodone

NORTH LIBERTY, Iowa, Aug. 7, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, "Phenylethanoic Acid, Phenylpropanoic Acid and Phenylpropenoic Acid Conjugates and Prodrugs of Hydrocodone, Method of Making and Use Thereof."

The most recent Notice of Allowance pertains to additional composition of matter claims in support of KP201 and other novel prodrugs of hydrocodone, and adds to the intellectual property portfolio governing KP201, which was granted USPTO Patent No. 8,461,137 in June 2013 providing composition of matter protection for benzhydrocodone.   KP201, KemPharm's lead product candidate, is in development for the treatment of acute moderate to moderately severe pain with a new drug application (NDA) expected to be filed in Q2 2014. KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC).

Travis C. Mickle, Ph.D., president and CEO of KemPharm, commented, "The allowance of this patent strengthens KemPharm's intellectual property surrounding the development of KP201 as a prodrug of hydrocodone.  This second USPTO patent in the opioid space will provide additional claims related to our first patent for benzhydrocodone, which issued less than two months ago.  It also underscores the versatility and prolificacy of our LAT technology in generating new, unique molecules with therapeutic benefits, in particular with regard to abuse deterrent and side effect reducing properties when compared to currently marketed hydrocodone products."

About KemPharm
KemPharm is a biopharmaceutical company focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable Ligand Activated Therapy (LAT) approach.  The company utilizes its LAT technology to generate improved prodrug versions of FDA approved drugs in the high needs areas of pain, ADHD and other CNS diseases.  KemPharm's lead clinical candidate, KP201, is in development for the treatment of acute, moderate to moderately severe pain with a new drug application (NDA) expected to be filed in the second quarter of 2014. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC). KemPharm's pipeline is also highlighted by KP511, its hydromorphone prodrug for pain, and KP415, a prodrug of methylphenidate for the treatment of ADHD.  For more information on KemPharm, please visit the company's website at www.kempharm.com.

SOURCE KemPharm, Inc.

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