Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths
21 September 2004 - 5:00PM
PR Newswire (US)
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/
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