Vicuron Pharmaceuticals Announces Phase III Results of Anidulafungin Combination Regimen for Treatment of Invasive Aspergillosis KING OF PRUSSIA, Pa., March 24 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced results from a Phase III trial evaluating the company's lead product anidulafungin, a novel antifungal therapy, in combination with liposomal amphotericin B (LAmB) for the potential treatment of invasive aspergillosis infections. Aspergillosis is an opportunistic fungal infection acquired by patients with weakened immune systems and is frequently fatal. "These results demonstrate that we can combine these two treatments to fight invasive aspergillosis infections without increasing side effects," said Raoul Herbrecht, MD, Department of Hematology and Oncology, Hopital de Hautepierre, Strasbourg, France, and lead investigator in the study. "Anidulafungin's distinct mechanism of action, broad-spectrum activity and novel route of elimination make it a particularly attractive therapy for use in combination antifungal treatments." "In addition to providing important evidence that combining anidulafungin with an amphotericin agent is well-tolerated as first line therapy, these data confirm previous and other data that the pharmacokinetic profile of anidulafungin makes it well-suited for potential combination strategies to fight deadly invasive fungal diseases," said Timothy Henkel, M.D., Ph.D., Vicuron's Chief Medical Officer. Previous in vitro studies have shown compelling results demonstrating anidulafungin's additive or synergistic effect in combination with a variety of other antifungal agents. Results from another study evaluating the concomitant use of anidulafungin and voriconazole, an increasingly important agent for the treatment of aspergillosis, will be presented at an international medical meeting later this year. Study Details and Results The non-comparative, multi-center, global trial enrolled 30 patients with probable or proven invasive aspergillosis. Study patients were administered both LAmB at 3-5 mg per kg daily and anidulafungin intravenously at 100 mg daily, with an initial loading dose of 200 mg of anidulafungin on day one. The 95 percent confidence interval of the global response rate ranged from 12 to 49 percent. The combination was well tolerated with few drug-related serious adverse events. Adverse event and laboratory values at the end of the study were consistent with those expected for a critically ill patient population with invasive aspergillosis. About Anidulafungin Anidulafungin is a naturally occurring molecule that has been significantly improved through chemical modification. In vitro studies have demonstrated that anidulafungin combines both the potency and killing effects of the polyene class (e.g. amphotericin B) without the resistance problems found with the azole class (e.g., fluconazole). Anidulafungin is a broad- spectrum agent, and has been demonstrated to be highly potent in vitro against the fungi responsible for several serious fungal infections. Preclinical studies have shown that five-minute exposure to anidulafungin in vitro kills more than 99 percent of Candida, including fluconazole-resistant strains. Anidulafungin has no cross-resistance with azoles or amphotericin, and in the laboratory it has proven very difficult to develop resistance to anidulafungin. Anidulafungin also was well tolerated in a Phase I study when given in combination with cyclosporine, the leading chronic immunosuppressive drug. About Vicuron Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients in North America and Europe. The company has filed a New Drug Application with the U.S. Food and Drug Administration for its lead product, anidulafungin, a novel antifungal agent. The company's other lead product, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram-positive infections, is in Phase III clinical trials. The company's versatile research engine integrates industry-leading expertise in functional genomics, natural products discovery, mechanism-based drug design and combinatorial and medicinal chemistry. These approaches are yielding promising novel and next-generation compounds, many of which are in the later stages of preclinical development. In addition, the company has research and development collaborations with leading pharmaceutical companies, such as Pfizer and Novartis. Forward-Looking Statements This news release contains forward-looking statements that predict or describe future events or trends. The matters described in these forward-looking statements are subject to known andunknown risks, uncertainties and other unpredictable factors, many of which are beyond Vicuron's control. Vicuron faces many risks that could cause its actual performance to differ materially from the results predicted by its forward-looking statements, including the possibilities that clinical trials and the results thereof might be delayed, that the timing of the filing of any new drug application might be delayed, that subsequent clinical trials might indicate that a product candidate is unsafe or ineffective, that any filed new drug application may not be approved, that ongoing proprietary and collaborative research might not occur or yield useful results, that a third party may not be willing to license our product candidates on terms acceptable to us or at all, that competitors might develop superior substitutes for their products or market them more effectively, that a sales force may not be developed as contemplated and that one or more of its product candidates may not be commercialized successfully. The reports that Vicuron files with the U.S. Securities and Exchange Commission contain a fuller description of these and many other risks to which Vicuron is subject. Because of those risks, Vicuron's actual results, performance or achievements may differ materially from the results, performance or achievements contemplated by its forward- looking statement. The information set forth in this news release represents management's current expectations and intentions. Vicuron assumes no responsibility to issue updates to the forward-looking matters discussed in this news release. DATASOURCE: Vicuron Pharmaceuticals Inc. CONTACT: Dov A. Goldstein, M.D. of Vicuron Pharmaceuticals Inc., +1-610-205-2312, or ; or Ian McConnell of WeissCom Partners, +1-415-362-5018, or ; or E. Blair Schoeb of Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/

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