Vicuron (NASDAQ:MICU)
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Vicuron Pharmaceuticals Files Amendment to Anidulafungin New Drug
Application (NDA) for Treatment of Esophageal Candidiasis
KING OF PRUSSIA, Pa., May 31 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals
Inc. (Nasdaq: MICU; Nuovo Mercato) announced it filed an amendment to its
existing anidulafungin New Drug Application (NDA) with the U.S. Food and Drug
Administration for the treatment of esophageal candidiasis. The amendment
provides supplemental clinical data including data on the 100 mg dose of
anidulafungin from the previously announced Phase 3 trial demonstrating
superiority of anidulafungin versus fluconazole in invasive
candidiasis/candidemia.
"We are pleased to have filed this NDA amendment in the second quarter as
planned, and remain on track to file a new NDA for the treatment of invasive
candidiasis/candidemia in the third quarter," said George F. Horner, III,
Vicuron's President and Chief Executive Officer.
About Anidulafungin
Anidulafungin is a product candidate made through chemical modification of a
naturally occurring molecule. 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
not shown 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 1 study when given in
combination with cyclosporine, a leading chronic immunosuppressive drug.
About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering,
developing, manufacturing and commercializing vital medicine for seriously ill
patients. The company has two New Drug Applications submitted to the U.S. Food
and Drug Administration for its lead products, dalbavancin, a novel intravenous
antibiotic for the treatment of serious Gram-positive infections, and
anidulafungin, a novel antifungal agent. Vicuron applies a disciplined,
integrated approach to anti-infective discovery for next- generation compounds
in both hospital-based and community-acquired infections. In addition, the
company has research and development collaborations with leading pharmaceutical
companies, such as Pfizer.
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 or
unsuccessful, that the timing of the filing of any new drug application or any
amendment to a new drug application might be delayed, that clinical trials
might indicate that a product candidate is unsafe or ineffective, that the FDA
might require additional information to be submitted and additional actions to
be taken before it will make any decision, that any filed new drug application
may not be approved by the FDA, that ongoing proprietary and collaborative
research might not occur or yield useful results, that the pipeline may not
yield a new clinical candidate or a commercial product, that a third party may
not be willing to license Vicuron's product candidates on terms acceptable to
it or at all, that competitors might develop superior substitutes for Vicuron's
products or market these competitive products more effectively, that a sales
force may not be developed as contemplated and that one or more of Vicuron's
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 E. Blair Schoeb of WeissComm
Partners, +1-212-331-7813, or , or Heather May of
Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron
Pharmaceuticals Inc.
Web site: http://www.vicuron.com/