Pipex Pharmaceuticals, Inc. (“Pipex”) AMEX:PP is a development-stage, specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and autoimmune diseases. Our strategy is to exclusively in-license proprietary, clinical-stage drug candidates that have demonstrated clinical efficacy and to complete the further clinical testing and manufacturing sufficient to seek marketing authorizations via the filing of new drug applications (NDAs) with the FDA and marketing application authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA).
A key component of our strategy encompasses the efficient and timely development of our clinical-stage drug candidates through the selection of initial indications representing high unmet medical needs and which may therefore benefit from an expeditious regulatory approval process. Once approved, these drug candidates may then be expanded into additional therapeutic indications through additional post-approval clinical trials and supplemental NDA (sNDA) filings. Our lead drug candidate, COPREXA™, is a novel, oral, anti-copper therapeutic that has completed two pivotal phase III clinical trials in neurologically-presenting Wilson’s disease. Based upon FDA communication, we believe that the results of these clinical trials demonstrated sufficient clinical safety and efficacy to support the filing of an NDA in the U.S. for this initial indication. We are currently conducting additional phase II clinical trials of COPREXA™ in order to expand the potential post-approval therapeutic utility of COPREXA™ into additional therapeutic indications, such as idiopathic pulmonary fibrosis (IPF) and other copper mediated neurodegenerative diseases.