ViroPharma Incorporated (VPHM)

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ViroPharma's antibiotic Vancocin gets new label
ViroPharma says FDA approved new label for Vancocin; says change could block generic versions
APAP – 4 hours ago


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EXTON, Pa. (AP) -- ViroPharma Inc. said Wednesday that regulators approved a new label for its antibiotic Vancocin with data on its safety and effectiveness, and the company believes the change will keep generic versions of the drug off the market for the next 3 years.

Shares of ViroPharma jumped $4.21, or 17.9 percent, to close Wednesday at $27.80. The stock was unchanged in aftermarket trading.

ViroPharma said the new label includes data on the safety and effectiveness of Vancocin as a treatment for Clostridium difficile, an intestinal infection that can cause symptoms ranging from diarrhea to potentially life-threatening inflammation of the colon. The drug is approved as a treatment for diarrhea associated with C. difficile and for gastrointestinal infections caused by Staphylococcus aureus.

The company said it believes the new labeling will prevent the approval for generic versions of Vancocin, or vancomycin, for another three years. In the third quarter, sales of the drug rose 13 percent to $76.6 million.

The information used in the new label comes from studies of Vancocin and an experimental drug being studied by Sanofi's Genzyme unit. ViroPharma said it bought the rights to use the studies. It will pay Genzyme royalties of 10 percent on net Vancocin sales over the next two years, and 16 percent the year after that.