VICURON - Class action
LCSR Announces Class Action Lawsuit Against Vicuron Pharmaceuticals Inc.
June 18, 2004 – Lerach Coughlin Stoia & Robbins LLP today announced that a class action has been commenced in the United States District Court for the Eastern District of Pennsylvania on behalf of purchasers of Vicuron Pharmaceuticals Inc. (“Vicuron”) (NASDAQ:MICU) common stock during the period between January 6, 2003 and May 24, 2004 (the “Class Period”).
The complaint charges Vicuron and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Vicuron claims to focus upon anti-infective products that have competitive advantages over existing products, such as greater potency, improved effectiveness against resistant strains and reduced toxicity. The Company's lead product candidate, anidulafungin, is intended for the intravenous treatment of fungal infections. Anidulafungin is the subject of late-stage clinical trials for the treatment of esophageal candidiasis, as well as for the treatment of invasive aspergillosis and invasive candidiasis/candidemia.
The complaint alleges that during the Class Period, defendants artificially inflated the price of Vicuron stock by concealing critical material information regarding the details of both the safety and efficacy of anidulafungin. Defendants concealed key adverse information regarding the development and commercialization of anidulafungin, raising serious concerns for the very approval of the drug for the treatment of esophageal candidiasis and other selected indications.
According to the complaint, each of the defendants knew, but concealed from the investing public, that: (i) the failure of anidulafungin to achieve superiority in all clinical measures over fluconazole in the Phase III trial for esophageal candidiasis stood in stark contrast to the fact that the in vitro antifungal activity of anidulafungin was nearly twenty-fold higher than fluconazole; (ii) the failure of anidulafungin to achieve superiority in all clinical measures over fluconazole in the Phase III trial for esophageal candidiasis stood in stark contrast with claims made in early-stage clinical trials that better clinical outcomes could be achieved with anidulafungin, versus fluconazole, in treating candidiasis; (iii) it was relevant to compare anidulafungin to caspofungin acetate, an approved drug similar in structure and mechanism of action, in that caspofungin acetate did not demonstrate a statistically significant higher relapse rate relative to fluconazole in similar studies for the same indication; (iv) the fact that anidulafungin demonstrated a statistically significant higher relapse rate relative to fluconazole raised concerns that anidulafungin was an inferior therapy to fluconazole and caspofungin acetate for the treatment of esophageal candidiasis in immunosuppressed patients; (v) the observation of higher statistically significant clinical relapse rates for anidulafungin relative to fluconazole or caspofungin acetate would adversely impact marketing claims for anidulafungin; (vi) the clinical relevance of the statistically significant differences in relapse rates was summarily dismissed to facilitate a business decision to file a New Drug Application, despite the fact that the adverse clinical relapse data clearly undermined the label claim sought for use of anidulafungin in the treatment of esophageal candidiasis; (vii) the nature and outcome of any additional studies was uncertain, resulting at best in a greatly delayed approval of anidulafungin for esophageal candidiasis or at worst insurmountable obstacles that would prevent the drug from ever being approved; (viii) although the Phase III study for anidulafungin for the treatment of esophageal candidiasis was completed during the fourth quarter of 2002, the announcement of the results of the study were delayed until after the Company had completed its merger with Biosearch Italia S.p.A. late in the first quarter of 2003; and (ix) the failure to disclose the defective nature of the anidulafungin Phase III study for esophageal candidiasis would prevent investors and Biosearch shareholders from learning the extent of the misrepresentations made to them during the Class Period.
The partial disclosure of the contents of an FDA letter on Monday, May 24, 2004, detailing the failure of Vicuron to supply data necessary to support its very claim for the use of anidulafungin for the treatment of esophageal candidiasis caused Vicuron shares to plummet $8.86, to $13.04, for a loss of over 40% from the previous trading day and over 45% from its Class Period high of $23.90
LCSR Announces Class Action Lawsuit Against Vicuron Pharmaceuticals Inc.
June 18, 2004 – Lerach Coughlin Stoia & Robbins LLP today announced that a class action has been commenced in the United States District Court for the Eastern District of Pennsylvania on behalf of purchasers of Vicuron Pharmaceuticals Inc. (“Vicuron”) (NASDAQ:MICU) common stock during the period between January 6, 2003 and May 24, 2004 (the “Class Period”).
The complaint charges Vicuron and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Vicuron claims to focus upon anti-infective products that have competitive advantages over existing products, such as greater potency, improved effectiveness against resistant strains and reduced toxicity. The Company's lead product candidate, anidulafungin, is intended for the intravenous treatment of fungal infections. Anidulafungin is the subject of late-stage clinical trials for the treatment of esophageal candidiasis, as well as for the treatment of invasive aspergillosis and invasive candidiasis/candidemia.
The complaint alleges that during the Class Period, defendants artificially inflated the price of Vicuron stock by concealing critical material information regarding the details of both the safety and efficacy of anidulafungin. Defendants concealed key adverse information regarding the development and commercialization of anidulafungin, raising serious concerns for the very approval of the drug for the treatment of esophageal candidiasis and other selected indications.
According to the complaint, each of the defendants knew, but concealed from the investing public, that: (i) the failure of anidulafungin to achieve superiority in all clinical measures over fluconazole in the Phase III trial for esophageal candidiasis stood in stark contrast to the fact that the in vitro antifungal activity of anidulafungin was nearly twenty-fold higher than fluconazole; (ii) the failure of anidulafungin to achieve superiority in all clinical measures over fluconazole in the Phase III trial for esophageal candidiasis stood in stark contrast with claims made in early-stage clinical trials that better clinical outcomes could be achieved with anidulafungin, versus fluconazole, in treating candidiasis; (iii) it was relevant to compare anidulafungin to caspofungin acetate, an approved drug similar in structure and mechanism of action, in that caspofungin acetate did not demonstrate a statistically significant higher relapse rate relative to fluconazole in similar studies for the same indication; (iv) the fact that anidulafungin demonstrated a statistically significant higher relapse rate relative to fluconazole raised concerns that anidulafungin was an inferior therapy to fluconazole and caspofungin acetate for the treatment of esophageal candidiasis in immunosuppressed patients; (v) the observation of higher statistically significant clinical relapse rates for anidulafungin relative to fluconazole or caspofungin acetate would adversely impact marketing claims for anidulafungin; (vi) the clinical relevance of the statistically significant differences in relapse rates was summarily dismissed to facilitate a business decision to file a New Drug Application, despite the fact that the adverse clinical relapse data clearly undermined the label claim sought for use of anidulafungin in the treatment of esophageal candidiasis; (vii) the nature and outcome of any additional studies was uncertain, resulting at best in a greatly delayed approval of anidulafungin for esophageal candidiasis or at worst insurmountable obstacles that would prevent the drug from ever being approved; (viii) although the Phase III study for anidulafungin for the treatment of esophageal candidiasis was completed during the fourth quarter of 2002, the announcement of the results of the study were delayed until after the Company had completed its merger with Biosearch Italia S.p.A. late in the first quarter of 2003; and (ix) the failure to disclose the defective nature of the anidulafungin Phase III study for esophageal candidiasis would prevent investors and Biosearch shareholders from learning the extent of the misrepresentations made to them during the Class Period.
The partial disclosure of the contents of an FDA letter on Monday, May 24, 2004, detailing the failure of Vicuron to supply data necessary to support its very claim for the use of anidulafungin for the treatment of esophageal candidiasis caused Vicuron shares to plummet $8.86, to $13.04, for a loss of over 40% from the previous trading day and over 45% from its Class Period high of $23.90
