14:30 VPHM resumes trading at 3pm EST. VPHM announces approval of modernized labeling for Vancocin (vancomycin hydrochloride, USP) capsules (23.36 -0.23)
Through the sNDA approval, Vancocin's label for the first time includes clinical safety and efficacy data for Vancocin in treating currently circulating strains of Clostridium difficile, including the BI/NAP1 strain. Vancocin's labeling now includes important safety and efficacy data from 260 patients with C. difficile associated diarrhea treated with Vancocin in two pivotal studies of Sanofi-Aventis' (SNY) Genzyme Corporation's investigational drug, tolevamer. The co purchased exclusive rights to the two studies from Genzyme for which it will pay Genzyme royalties of 10%, 10% and 16% on net sales of Vancocin for the three year period following the approval of the sNDA. As a result of today's sNDA approval, ViroPharma believes Vancocin meets the requirements for, and thus has, three years of exclusivity, and that generic vancomycin capsules will not be approved during this period. Ultimately, the decision on a grant of three-year exclusivity and its effect on generic vancomycin capsule approvals resides with the FDA... Co also provided updates on ViroPharma's ongoing citizen petition and litigation with the FDA regarding Vancocin. ViroPharma has two suits pending against FDA regarding Vancocin. Oral arguments on the district court's procedural dismissal of this suit are currently scheduled for January 13, 2012 before the United States Court of Appeals for the District of Columbia Circuit. (stock is halted)
Take time to look around, even on a down day!
