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KemPharm, Inc. Receives Notice of Allowance for Novel Pain Drug Candidate, KP201


4/3/2013 11:49:49 AM

NORTH LIBERTY, Iowa, April 3, 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 entitled, "Benzoic Acid, Benzoic Acid Derivatives and Heteroaryl Carboxylic Acid Conjugates of Hydrocodone, Prodrugs, Methods of Making and Use Thereof."

KP201, recently designated by USAN as benzhydrocodone, 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. Benzhydrocodone 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 soon-to-be issued patent will claim compositions of benzhydrocodone, a novel opioid prodrug. This Notice of Allowance indicates the unique structure and the distinct and non-obvious properties of benzhydrocodone compared to currently marketed hydrocodone products."

Mickle continued, "The Allowance by the USPTO represents another significant step in the development of KP201 and serves as evidence for the unique products that can be generated by our Ligand Activated Therapy (LAT) technology platform. The elegance of KP201, in which a proprietary, non-toxic ligand is attached to hydrocodone, offers several clinical and developmental advantages, including a clear regulatory pathway and the ability to mitigate drug side effects and abuse potential. Based on the FDA's recent draft industry guidance for 'Abuse-Deterrent Opioids,' we are very confident that KP201 is optimally designed for continued clinical advancement and represents a first-in-class opioid-based drug that possesses the ability to reduce abuse potential and opioid-induced constipation."

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 companyutilizes 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


For KemPharm, Inc.:

Media / Investor Contacts:



Christal Mickle

Jason Rando / Claire Sojda



319-665-2575

Tiberend Strategic Advisors, Inc.



info@kempharm.com

212.827.0020




jrando@tiberend.com




csojda@tiberend.com


SOURCE KemPharm, Inc.



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