Pipex to file NDA for Coprexa

During the two separately scheduled pre-NDA meetings, Pipex reviewed with the FDA the format and content of Pipex's planned new drug application (NDA) submission of preclinical, clinical, manufacturing, stability and quality data for Coprexa for the treatment of initially-presenting neurologic Wilson's disease.

Charles Bisgaier, president, said: “We view the meeting outcomes as highly positive, productive and informative, providing us with considerable clarity to assure that our planned application will meet the agency's needs. The meetings have given us considerable confidence that in November we will be able to submit an acceptable NDA package for FDA's review.”

Steve Kanzer, chairman & CEO said: “Based on our positive interactions with the FDA and our prior commitment to update investors in this third week of September, we are pleased to provide this updated guidance to the investment community for the timing of our proposed Coprexa NDA filing.”

Wilson's disease is a genetic disease which leads to an inability to properly clear excess free copper from the body via the liver into the bile and stool. As a result, copper accumulates in the body, causing significant neurologic damage, resulting in tremors, impaired speech, and Parkinson's-like dystonia.