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Ampio Provides Progress Report on Clinical Programs in Preparation for Annual Shareholders Meeting
Date:11/14/2012

orbid premature ejaculation and erectile dysfunction (ED).

  • Ampio has completed two phase 3 clinical trials in Europe on Zertane™.
  • Ampio is poised to file an IND for pivotal trials under the 505(b)2 pathway in the USA adhering to the guidance provided by the FDA during our Pre-IND meeting.
  • Ampio has identified sites to conduct its pivotal trials in the USA.
  • Ampio will be filing for approval of Zertane™, based on the European trials results, in Australia (TGA). Approval in Australia will facilitate approval in many countries in Latin America and the Pacific Rim where we have already licensed Zertane™.
  • Ampio has secured a manufacturing agreement with Ethypharm (France) to produce the ODT formulation of Zertane™, which will be used for the pivotal trials in the USA.
  • Ampio entered into a contract with Syngene (Bangalore, India) to manufacture Zertane ED™, which will be used in clinical trials in South Korea, in compliance with FDA standards, by its partner/licensee Daewoong.
  • Ampio was awarded multiple US and international patents on Zertane™ and was recently awarded patents on the combination treatment for PE and ED (as well as patents for the reduction of potential side effects of tramadol) in China, Europe and multiple other countries.
  • Ampio has secured licenses in Brazil and S. Korea for these drugs and is currently in discussions with potential global partners.
  • Ampio has contracted Pharmerit, Inc. (Cambridge, MA) to complete the development of the Patient Outcome for Premature Ejaculation (POPE) patient reported outcome (PRO) tool for the evaluation of premature ejaculation therapy. When completed in the next few weeks this will be the only validated PRO tool for PE in the FDA environment.  The completion of the POPE trial will allow Ampio to file the IND in the USA and conclude its negotiations with phar
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SOURCE Ampio Pharmaceuticals, Inc.
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