Vicuron Pharmaceuticals Receives Approvable Letter from FDA for Anidulafungin For the Treatment of Esophageal Candidiasis Reques
24 May 2004 - 5:00PM
PR Newswire (US)
Vicuron Pharmaceuticals Receives Approvable Letter from FDA for
Anidulafungin For the Treatment of Esophageal Candidiasis
Requesting Additional Data - Conference Call Scheduled for 8:30
a.m. EDT - KING OF PRUSSIA, Penn., May 24 /PRNewswire-FirstCall/ --
Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU)
today announced that it received an approvable letter from the U.S.
Food and Drug Administration (FDA). However, the letter indicated
that the company's NDA submission for anidulafungin does not
currently support a labeling claim for the initial treatment of
esophageal candidiasis. In the letter, the FDA indicated that
Vicuron could potentially achieve approval for anidulafungin upon
the completion of Vicuron's ongoing Phase III clinical trial for
the treatment of invasive candidiasis/candidemia or the completion
of further clinical work in patients with candidal disease
refractory to other treatments. "We intend to meet with the FDA to
discuss all of our options with respect to the approval of
anidulafungin as soon as possible, and intend to complete the Phase
III trial in invasive candidiasis/candidemia by the end of this
year," said George F. Horner III, President and CEO of Vicuron. "We
also will take appropriate management action to reduce the expenses
of the company in light of this delay." 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, a leading
chronic immunosuppressive drug. Conference Call Information Vicuron
will host a conference call today at 8:30 a.m. (Eastern Standard
Time). To access the live call or the seven-day 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
1-877-703-8543 (U.S.) or 1-706-679-3840 (international) to listen
to the call. Telephone replay is available from approximately one
hour after the call through May 31, 2004. To access the replay,
please call 1-800-633-8284 (U.S.) or 1-402-977-9140
(international). The conference ID number is 21196702. 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 received an
approvable letter for its lead product anidulafungin in May 2004.
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 Hala Bashir, of
WeissCom Partners, +1-917-929-1734, , for Vicuron Pharmaceuticals
Inc.; or E. Blair Schoeb, of Burns McClellan, , for Vicuron
Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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