Vicuron (NASDAQ:MICU)
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Vicuron Pharmaceuticals Provides Update on Anidulafungin
Regulatory Paths
Conference Call Scheduled Today at 8:30 a.m. EDT
KING OF PRUSSIA, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Vicuron
Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today provided an update on
the status of its New Drug Application (NDA) for anidulafungin, its novel
antifungal agent.
In May of this year, Vicuron received an approvable letter from the U.S. Food
and Drug Administration (FDA) for anidulafungin.
Based upon Vicuron's discussions with the agency and the approvable letter,
Vicuron plans to pursue the following two paths to approval:
1. For the potential treatment of esophageal candidiasis: The initial NDA
has been kept open and Vicuron will file an amendment to that NDA for
this indication. The amendment will provide supplemental clinical data
for anidulafungin largely at the 100 mg dose from studies with
enrollment already completed. The amendment is currently anticipated
to be submitted in the second quarter of 2005. Under this timeline,
the fourth quarter of 2005 is the earliest anidulafungin could be
approved for this indication.
2. For the potential treatment of invasive candidiasis/candidemia:
Vicuron will file a new NDA for this indication using integrated
clinical data, including data from the recently-completed pivotal Phase
3 trial, the results of which are expected to be released in the first
half of 2005. Vicuron plans to submit this NDA in the third quarter of
2005 and expects a standard review period.
"We now believe that we have defined paths to approval for anidulafungin in two
indications," said George F. Horner, III, President and Chief Executive Officer
of Vicuron. "We will continue to work closely with the agency on both of these
programs."
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 1 study when given in combination with
cyclosporine, a leading chronic immunosuppressive drug.
Conference Call Information
Vicuron will host a conference call today at 8:30 a.m. (Eastern Time). To
access the live call or the archive via the Internet, log on to
http://www.vicuron.com/. Please connect to Vicuron's website at least 15
minutes prior to the conference call to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively, please call
1-800-822-4794 (U.S.) or 1-913-981-4912 (international) to listen to the call.
Telephone replay is available from approximately one hour after the call
through September 28, 2004. To access the replay, please call 1-888-203-1112
(U.S.) or 1-719-457-0820 (international). The replay access code is 853414.
About Vicuron
Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering,
developing, manufacturing and commercializing vital medicine for seriously ill
patients. In May 2004, Vicuron received an approvable letter from the FDA for
its lead product anidulafungin for the treatment of esophageal candidiasis.
The company's other lead product, dalbavancin, a novel intravenous antibiotic
for the treatment of serious Gram-positive infections, has completed Phase 3
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, 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 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 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 Hala Bashir of WeissComm
Partners, +1-212-204-2080, or , or Aline Schimmel of
Burns McClellan Inc., +1-212-213-0006, or , both for
Vicuron Pharmaceuticals Inc.
Web site: http://www.vicuron.com/