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Ampio Strengthens Patent Protection for Lead Drug Ampion™
Date:3/20/2012

GREENWOOD VILLAGE, Colo., March 20, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Zertane™ completed two phase III studies, Ampion™-completed proof of concept studies and Optina™), licensing distribution of these drugs and engaged in further drug development, today announced that it has received notice of allowance from the US Patent Office of an additional patent that complements and expands its anti inflammatory patent portfolio for its lead drug Ampion™.

Gary Connell, Ampio patent counsel from Sheridan Ross PC of Denver stated: "The allowed claims in this new patent protect pharmaceutical compositions that include the use of the low molecular weight fraction of commercially available (approved) human serum albumin for any use, including the injectable used in the osteoarthritis of the knee study conducted in Australia. The allowed patent claims further strengthen Ampio's patent portfolio by providing specific coverage for a pharmaceutical composition produced using the same method by which the Ampion™ product in clinical trials was produced."

Dr. Vaughan Clift, Chief Regulatory Officer of Ampio noted: "A meeting with the CBER (Center for Biological Evaluation and Research) division of the FDA is scheduled to occur by the end of April 2012. The purpose of the meeting is to obtain guidance and clarity about the path and conduct of pivotal trial(s) in the US for approval of Ampion™ for reducing pain in osteoarthritis of the knee. We have provided the FDA a pre-IND package that includes scientific evidence as well as the results of the osteoarthritis of the knee trial results (safety, efficacy and manufacturing data) conducted in Australia, which indicated no safety concerns and statistically significant efficacy trends c
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SOURCE Ampio Pharmaceuticals, Inc.
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