Vicuron Pharmaceuticals Announces Data Presentations at ECCMID Annual Meeting In Prague KING OF PRUSSIA, Pa., April 28 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq MICU; Nuovo Mercato) today announced that data on its two late-stage lead product candidates, anidulafungin and dalbavancin, will be presented at the 14th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Prague, Czech Republic next week. Highlights include: -- In vitro data demonstrating anidulafungin's superior potency versus existing agents against a broad range of Candida species; -- A series of pharmacokinetic studies demonstrating that anidulafungin can be used in patients with potentially complicating conditions without drug-drug interactions or hepatic (liver) toxicity; -- Results of a Phase I clinical trial evaluating co-administration of anidulafungin and voriconazole showed no sign of drug-drug interactions and the regimen was well-tolerated; and -- Positive data from a previously reported Phase II clinical trial demonstrating the superior efficacy of once-weekly dalbavancin versus vancomycin twice daily for the treatment of catheter-related blood stream infections. "Vicuron's strong presence at this major international meeting underscores our emerging leadership in the hospital antifungal and antibiotic markets," said George F. Horner III, President and Chief Executive Officer of Vicuron. "With regulatory action on anidulafungin expected later this quarter, these data presentations confirm the potential of anidulafungin to become an important broad-spectrum, highly potent antifungal agent for use in a wide range of patients. In addition, the complete Phase II dalbavancin data in tough-to-treat bloodstream infections is truly breakthrough as it is the first time any Gram-positive injectable antibiotic has been shown to be superior to vancomycin in these types of infections." The abstracts and oral presentations are listed below: Anidulafungin 1. Sunday May 2 - 12:00-1:00 p.m.; Poster Session I Comparison of the In Vitro Activity of Anidulafungin with Amphotericin B, Caspofungin, Fluconazole, Intraconazole and Voriconazole Against a Panel of 780 Yeasts Obtained from Five European Centres, EM Johnson, BP Goldstein. Poster #513. 2. Monday May 3 - 12:00-1:00 p.m., Poster Session IIIAnidulafungin Pharmacokinetics are Not Affected by Concomitant Voriconazole. J. Dowell, J. Schranz. Poster #1034. 3. Monday May 3 - 12:00-1:00 pm., Poster Session IIIPopulation Pharmacokinetics Confirms Absence of Anidulafungin Drug-Drug Interactions. M. Stogniew, J.A. Dowell. Poster #1035. 4. Monday May 3 - 12:00-1:00 p.m., Poster Session IIIAssessment of Pharmacokinetics of Anidulafungin in Patients with Invasive Aspergillosis Receiving Concomitant Liposomal Amphotericin B. J. Dowell, J. Schranz. Poster #1036. 5. Tuesday May 4 - 1:00-2:00 p.m., Poster Session VI Lack of Hepatic Effect of Anidulafungin. D. Krause, J. Schranz. Poster #1789. Dalbavancin 1. Monday May 3 - 12:00-1:00 p.m., Poster Session III Efficacy and Safety of Weekly Dalbavancin v. Vancomycin in Catheter-related Bloodstream Infections (CRBSI). E. Seltzer, M. Wible. Poster #934. 2. Monday May 3 - 12:00-1:00 p.m., Poster Session III Evaluation of Dalbavancin Activity and Spectrum Tested Against European Isolates. R.N. Jones, T.R. Fritsche. Poster #936. 3. Monday May 3 - 12:00-1:00 p.m., Poster Session III Once Weekly Dalbavancin in Catheter-related Bloodstream Infections: Microbiological Findings. B.P. Goldstein, R.N. Jones. Poster #935. 4. Monday May 3 - 12:00-1:00 p.m., Poster Session III Activity of Dalbavancin Against European Clinical Isolates of Staphylococci and Streptococci. R. Flamm, D. Draghi. Poster #932. 5. Monday May 3 - 12:00-1:00 p.m., Poster Session III In Vitro Anti-staphylococcal and Anti-streptococcal Activity of Dalbavancin, Assessed by British and NCCLS Methods. S. Mustaq, M. Warner. Poster #933. 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 species, 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 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. Currently, once-weekly administration of dalbavancin is being studied in multiple Phase III clinical trials of complicated and uncomplicated skin and soft tissue infections. 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, 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 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 , 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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