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TMCNet:  KemPharm, Inc. Receives Positive Feedback from FDA on KP201 Clinical Plan

[November 19, 2012]

KemPharm, Inc. Receives Positive Feedback from FDA on KP201 Clinical Plan

NORTH LIBERTY, Iowa --(Business Wire)--

KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today a successful Type B meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201. The meeting was held to obtain input from the Agency in regard to the remaining clinical and non-clinical program required for submission of a new drug application (NDA) for KP201.

KemPharm presented to the FDA its clinical and non-clinical data that have been completed to date along with its remaining proposed studies in support of a potential 505(b)(2) filing pathway.

"Based on the discussion KemPharm had with the Agency, we are confident that KP201 will be able to proceed under a 505(b)(2) filing which will allow for a greatly shortened development timeline compared to most new chemical entities," stated Dr. Sven Guenther, Vice President of Research. "Additionally, the remaining studies, both clinical and non-clinical, along with manufacturing, represent a fairly low development risk."

KP201 is in development for the treatment f acute moderate to moderately severe pain with a new drug application on target to be filed in Q2 2014.

About KP201
KemPharm's most advanced opioid-based drug candidate, KP201, is composed of hydrocodone chemically bound to a ligand. The Company previously reported positive Phase 1 clinical data, which confirmed that KP201 is metabolized in man as predicted, releasing hydrocodone into the bloodstream at amounts equivalent to the reference listed drug, Norco®. This data supports a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen.

KP201 has 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). Importantly, intact KP201 was not detected in systemic circulation during a Phase I study, suggesting that minimal additional studies could be justified to determine the impact of KP201 exposure in the body.

KemPharm has worked diligently with its manufacturing partner, Johnson Matthey, to successfully and efficiently scale up KP201 active pharmaceutical ingredient (API) in anticipation of a commercial launch. KP201 is on track for an NDA submission to the FDA in 2014.

About KemPharm
KemPharm is focused on the discovery and development of 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. KemPharm's business strategy includes seeking strategic development partners following rapid clinical proof-of-concept demonstration. KemPharm also plans to explore discovery stage alliances with industry leaders, leveraging its prodrug know-how and LAT technology. KemPharm is primarily focused on developing candidates for pain and other central nervous system disorders.

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