PRNewswire-FirstCall (May 04, 07:34 AM) PRAGUE, Czech Republic, May 4 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced the presentation of in vitro data demonstrating that the company's lead product anidulafungin, a novel antifungal agent, was the most potent when compared to five other antifungal agents against Candida infections. The data were presented today at the 14th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Prague, Czech Republic.
Data from the in vitro study analyzed activity against 781 recent European isolates of Candida species; the agents compared were anidulafungin, caspofungin, amphotericin B, fluconazole, itraconazole and voriconazole. Anidulafungin was the most potent agent overall and was active against all azole-resistant isolates.
Other data presented at ECCMID from a series of studies investigating anidulafungin's pharmacokinetic properties indicate that the therapy can be used in combination with many common agents and support a lack of drug-drug interactions. In particular, anidulafungin given in combination with voriconazole, an increasingly important antifungal agent, was shown to be well-tolerated with no drug-drug interactions.
"The anidulafungin data presented here indicate that the therapy's superior in vitro potency against Candida species, including albicans, galbrata, and krusei, and its favorable pharmacokinetic profile may make it a useful agent for a wide range of seriously ill patients," said Timothy J. Henkel, M.D., Ph.D., Chief Medical Officer of Vicuron. "The epidemiology of fungal disease often demands the use of broad-spectrum therapy like anidulafungin that can be employed to treat suspected or confirmed fungal diseases. The data supporting the lack of drug-drug interactions or need for dose adjustments in patients with kidney or liver impairment is particularly reassuring for physicians treating very sick patients, who are often on other medications and have multiple organ dysfunction."
Other ECCMID Anidulafungin Data Highlights
Pharmacokinetic Data - Key Findings:
-- Anidulafungin pharmacokinetics were not affected by concomitant use of
voriconazole in a study of 18 healthy volunteers; the combination was
well-tolerated;
-- No drug-drug interactions were identified in a study of pooled data
from 225 patients in four Phase II and III trials;
-- Anidulafungin was well-tolerated, with a safety profile comparable to
oral fluconazole in a Phase III study of 601 patients with esophageal
candidiasis;
-- Anidulafungin pharmacokinetics were not affected by concomitant use of
liposomal amphotericin B in a study of 27 patients; and
-- Disease state (invasive aspergillosis or candidiasis) did not affect
the pharmacokinetics of anidulafungin.
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 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.
Vicuron Pharmaceuticals Inc.
CONTACT: Dov A. Goldstein, M.D. of Vicuron Pharmaceuticals Inc.,+1-610-205-2312, or dgoldstein@vicuron.com; or Hala Bashir of WeissComPartners, +1-212-204-2080, or Hala@weisscom.net, for Vicuron PharmaceuticalsInc.; or E. Blair Schoeb of Burns McClellan Inc., +1-212-213-0006, orbschoeb@burnsmc.com, for Vicuron Pharmaceuticals Inc.
Web site: http://www.vicuron.com/
