KemPharm, Inc. Receives Notice of Allowance for Novel Prodrug of Hydromorphone

CORALVILLE, Iowa, April 30, 2014 /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, "Benzoic Acid, Benzoic Acid Derivatives and Heteroaryl Carboxylic Acid Conjugates of Hydromorphone, Prodrugs, Methods of Making and Use Thereof."  The patent application governs composition of matter for KP511, KemPharm's prodrug of hydromorphone.

KP511 is the second most advanced product candidate in KemPharm's pain therapy portfolio, which includes KP201, the company's lead product candidate, which is a prodrug of hydrocodone, and KP606, a prodrug of oxycodone.  Similar to KP201, which was granted composition of matter protection (USPTO Patent No. 8,461,137), KP511 is a new chemical entity designed to offer 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). 

In preclinical studies, KP511 exhibited superior pharmacological characteristics that may suggest an improved safety profile compared to currently marketed hydromorphone products, possibly reducing or preventing symptoms of constipation and limiting abuse potential. KP511 also features tamper resistant properties that make it difficult to extract hydromorphone from the prodrug, which is not active until cleaved in the body.  Additionally, at high doses, KP511 has shown the potential to saturate the processes that metabolize it to hydromorphone thus hypothetically limiting or eliminating the risk of overdose.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "KemPharm's strategy is to leverage our Ligand Activated Therapy (LAT) prodrug technology to develop a franchise of new chemical entities designed specifically to address key shortcomings with currently marketed opioid-based therapeutics, namely abuse potential and constipation, in order to provide patients and care providers with better, more responsible options for treating pain.  Today's patent allowance for KP511 serves to further cement the differentiation of our technology platform as well as strengthen the value potential of the drug and our overall pipeline." 

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.  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, KP606, its oxycodone 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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