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KemPharm, Inc. Receives Patent from the USPTO for Novel Pain Drug Candidate, KP201
Date:6/11/2013

NORTH LIBERTY, Iowa, June 11, 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 the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,461,137 to KemPharm for its patent application entitled, "Benzoic Acid, Benzoic Acid Derivatives and Heteroaryl Carboxylic Acid Conjugates of Hydrocodone, Prodrugs, Methods of Making and Use Thereof." 

The patent, which extends through 2031, provides composition of matter protection for benzhydrocodone, a novel prodrug of hydrocodone. 

Benzhydrocodone, the USAN designation for 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.  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, "This patent is a milestone achievement that reinforces the distinct properties of KP201 compared to currently marketed hydrocodone products.  Its unique chemical structure, which ensures the drug becomes active only when exposed to enzymes in the digestive system, offers numerous potential benefits, the two most prominent of which are the ability to deter abuse and reduce opioid-induced constipation.  Based on the issuance of the patent and the new USAN designation of benzhydrocodone, KemPharm can state with certainty that KP201 is unlike any opioid-based pain medication in development or on the market today."

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.comFor KemPharm, Inc:

Media / Investor Contacts:Christal Mickle

Jason Rando / Claire Sojda 319-665-2575

Tiberend Strategic Advisors, Inc.info@kempharm.com

212.827.0020jrando@tiberend.comcsojda@tiberend.com


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SOURCE KemPharm, Inc.
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