Vicuron Pharmaceuticals Completes Enrollment in Phase III Clinical Trials of Dalbavancin for Skin and Soft Tissue Infections Comprehensive Phase III Development Program Designed to Support U.S. NDA Filing in Late 2004 KING OF PRUSSIA, Pa., May 11 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced that it completed enrollment in three Phase III clinical trials involving over 1,500 patients designed to support registration of once-weekly dalbavancin for the treatment of skin and soft tissue infections (SSTIs). Vicuron expects to announce data from these studies in the second half of 2004 and file a New Drug Application for dalbavancin with the U.S. Food and Drug Administration by the end of 2004. "Vicuron completed enrollment in this comprehensive Phase III clinical development program for dalbavancin ahead of schedule," said George F. Horner III, President and Chief Executive Officer of Vicuron. "This important milestone achievement underscores our commitment to the therapeutic category and to demonstrating the benefits of our powerful and unique antibiotic, which we believe has significant advantages over currently available agents. With our first product candidate anidulafungin, a novel anti-fungal agent, awaiting a final FDA decision soon, and a regulatory filing expected for dalbavancin later this year, we are focused on becoming a leader in the hospital market." Phase III Program Details -- Complicated SSTIs: Randomized, controlled, double-blind study. Patients receive either intravenous dalbavancin or linezolid for 14 days. The primary endpoint is overall clinical and microbiological response at the conclusion of therapy. -- Uncomplicated SSTIs: Randomized, controlled, double-blind study. Patients receive either intravenous dalbavancin or intravenous cefazolin, followed by oral cephalexin. The primary endpoint is overall clinical and microbiological response at the conclusion of therapy. -- SSTIs caused by MRSA: Randomized, controlled, open-label study of patients with SSTIs suspected or confirmed to be caused by methicillin-resistant Staphylococcus aureus (MRSA). Patients receive either two doses of intravenous dalbavancin one week apart or twice daily doses of intravenous vancomycin for 14 days. The primary endpoint is an assessment of clinical response at the time of follow-up visit. About Dalbavancin Dalbavancin, a novel next-generation glycopeptide agent, belongs to the same class as vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to- treat strains of Staphlococcus (Staph.): MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been specifically designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically important Gram-positive bacteria, it is bactericidal (i.e., kills bacteria rather than merely inhibiting their growth). The potency, tissue penetration and long half-life of dalbavancin may allow for more flexible and convenient dosing regimens than vancomycin. Dalbavancin may also help reduce the length of hospital stays by decreasing the need for intravenous lines that increase the risk of local and bloodstream infection. In preclinical and clinical studies to date, dalbavancin appears to be one of the most potent antibiotics in its class against MRSA and MRSE and has not shown significant dose-limiting side effects. 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 major countries in 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, including 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 and unknown 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 Hala Bashir of WeissCom Partners, +1-212-204-2080, or , for Vicuron Pharmaceuticals Inc.; or E. Blair Schoeb of Burns McClellan Inc., +1-212-213-0006, or , for Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/

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