Key Developments: ViroPharma Inc (VPHM.O)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
ViroPharma Inc Lowers FY 2013 Worldwide Net Product Sales Guidance
ViroPharma Inc updated its fiscal 2013 guidance and now expects worldwide net product sales to be $440 million to $465 million. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $463 million for fiscal 2013. Full Article
ViroPharma Inc Reaffirms FY 2013 Net Product Sales Guidance
ViroPharma Inc updated its fiscal 2013 guidance and expects worldwide net product sales to be in the range of $450 to $475 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $462 million for fiscal 2013. Full Article
ViroPharma Inc Announces Publication Of Data Demonstrating Use Of Cinryze
ViroPharma Inc announced the publication of data demonstrating that use of Cinryze (C1 esterase inhibitor [human]) in pediatric patients provided relief from symptoms of hereditary angioedema (HAE) attacks and reduced the rate of attacks. HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of a human plasma protein called C1 inhibitor. The paper entitled Nanofiltered C1-Esterase Inhibitor for The Acute Management and Prevention of Hereditary Angioedema Attacks Due to C1-Inhibitor Deficiency in Children by Dr. William Lumry et al. describes the efficacy and the safety profile of Cinryze in prevention and treatment of HAE attacks in the analysis of pediatric data from prospective studies of patients with HAE ever reported in medical literature. The article is in press at The Journal of Pediatrics and was posted online on January 14, 2013 . Cinryze is approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE; Cinryze is not approved to treat HAE attacks or for procedural prophylaxis. Cinryze is not approved for use in children. According to published literature, in most patients with HAE, clinical symptoms manifest in childhood, typically between the ages of four and 11 years and may worsen during puberty. Full Article
ViroPharma Inc Issues FY 2013 Net Product Sales Guidance In Line With Analysts' Estimates
ViroPharma Inc announced that for fiscal 2013, it expects worldwide net product sales are expected to be $450 to $475 million, reflective of updated expectations for Vancocin. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $467 million for fiscal 2013. Full Article
ViroPharma Inc and Halozyme Therapeutics Inc Announce Initiation of Phase 2b Dose Ranging Combination Study for Subcutaneous Administration of Cinryze With Hyaluronidase
ViroPharma Inc and Halozyme Therapeutics Inc announced that ViroPharma has initiated its Phase 2b double blind, multicenter, dose ranging study to evaluate the safety and efficacy of subcutaneous (SC) administration of Cinryze (C1 esterase inhibitor [human)] in combination with Halozyme's Enhanze technology, drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in adolescents and adults with hereditary angioedema (HAE) for prevention of HAE attacks. Cinryze is currently approved for intravenous (IV) administration. Full Article
ViroPharma Inc's Cinryze (C1 Esterase Inhibitor [Human]) Prophylaxis Study Showed Safety Data of Escalating Doses In Patients With Hereditary Angioedema
ViroPharma Inc announced important data from an open-label, multicenter study to assess the safety, tolerability, and treatment effect of escalating doses of C1 INH-nf in patients with HAE who were not adequately controlled with 1000 U every three or four days. The results of this study were presented at the 2012 annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Anaheim, California. The data provide evidence for the safety profile of Cinryze (C1 esterase inhibitor [human]) at doses up to 2500 units in patients with hereditary angioedema (HAE). HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of a human plasma protein called C1 inhibitor. The presentation titled, Safety and Efficacy of Escalating Doses of C1 Esterase Inhibitor [Human] (Cinryze) as Prophylaxis in Patients with Hereditary Angioedema (HAE) was presentedby Dr. Jonathan A. Bernstein from the University of Cincinnati. The study was a post marketing FDA requirement to assess the safety and tolerability of escalating doses of Cinryze, with specific interest in thrombogenicity and immunogenicity. This study enrolled 20 eligible subjects over a 3 year period. Subjects with qualifying HAE attack rates, and who met other specified entry criteria, were entered into a 3-step dose-escalation algorithm. Full Article
ViroPharma Inc Lowers FY 2012 Revenue Guidance
ViroPharma Inc announced that for fiscal 2012, it expects net sales to be in the range of $425 to $435 million. Full Article
ViroPharma Inc Issues FY 2012 Revenue Guidance Above Analysts' Estimates-Conference Call
ViroPharma Inc announced that for fiscal 2012, it expects net sales range to be between $450-$475 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $447 million for fiscal 2012. Full Article
ViroPharma Inc Receives FDA Approval Of Cinryze Industrial Scale Manufacturing
ViroPharma Inc announced the U.S. Food and Drug Administration (FDA) has approved the supplement to the Cinryze Biologics License Application (BLA) for industrial scale manufacturing changes. As previously announced, the Company expects completion of labeling for previously produced vials to take approximately six weeks before entering into the trade. Full Article
Law Office of Brodsky & Smith, LLC Announces Investigation Of ViroPharma Inc
Law office of Brodsky & Smith, LLC announced that it is investigating potential violations of the Securities Exchange Act of 1934 by ViroPharma Inc (Viropharma or the Company). A class action lawsuit commenced in the United States District Court for the Eastern District of Pennsylvania alleges that on December 14, 2011 Viropharma issued a press release announcing the modernization of labeling for Vancocin Capsules effective through the FDA`s approval of a sNDA. The press release indicated that Viropharma believes Vancocin met the requirements for, and had three years of exclusivity, during which a generic Vancomycin capsules would not be approved. However, on April 10, 2012, the Company disclosed that Vancocin would not qualify for the three additional years of exclusivity and the FDA was approving three ANDA`s for generic Vancomycin capsules. In addition, the Company received notification that the Federal Trade Commission is conducting an investigation into whether the Company has engaged in unfair methods of competition with respect to Vancocin. As a result, at the close of trading on April 10, 2012, Viropharma shares had declined $6.17 per share or 22% to close at $22.44. Full Article
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