ITMN off in the premarket on Oritavancin delay:
>>7:11AM InterMune NDA for Oritavancin to be delayed (ITMN) 19.70: Co announced today that the New Drug Application (NDA) for Oritavancin will be delayed. InterMune had previously projected submitting an NDA in the first half of 2004 and now believes that the NDA cannot be submitted before the end of 2004. In two small clinical pharmacology studies, InterMune observed adverse events, primarily phlebitis and rash, which were inconsistent with the safety profile observed in prior trials of oritavancin, including the two Phase III studies. Since the cause of the inconsistency is unknown, on Nov 20, 2003, the FDA requested an additional clinical safety study, using oritavancin from the new contract manufacturer, be completed prior to the submission of the NDA. [Briefing.com note: Although not a lead candidate (peak sales $100 mln), this news is likely to put moderate pressure on the stock. Of note, CBST with its competing product Cubicin might benefit from the delay.]<<
Courtesy of Briefing.com
Cheers, Tuck |
