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ARTICLE | Company News

Pipex falls on Coprexa refusal to file

January 30, 2008 1:30 AM UTC

Pipex (AMEX:PP) was off $2.10 (52%) to $1.91 on Tuesday after FDA refused to file an NDA for Coprexa oral tetrathiomolybdate to treat initially presenting neurologic Wilson's disease. Pipex said FDA raised eight issues, including the adequacy of the analytical methodology to characterize the active ingredient of Coprexa; a request for an additional short-term reproductive safety study in animals; two preliminary assessments concerning the adequacy of the clinical evidence of Coprexa's safety and efficacy; and four formatting items.

Pipex said it "believes that the clinical and nonclinical deficiencies cited by the FDA were already discussed, resolved and agreed upon with the FDA during one of the two pre-NDA meetings held with a first review division of the FDA in August of last year." The company plans to meet with the agency within 30 days. ...