Vicuron Pharmaceuticals Announces Data Presentations at ECCMID Annual Meeting In Prague
April 28 2004 - 7:30AM
PR Newswire (US)
Vicuron Pharmaceuticals Announces Data Presentations at ECCMID
Annual Meeting In Prague KING OF PRUSSIA, Pa., April 28
/PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq
MICU; Nuovo Mercato) today announced that data on its two
late-stage lead product candidates, anidulafungin and dalbavancin,
will be presented at the 14th annual European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) meeting in Prague,
Czech Republic next week. Highlights include: -- In vitro data
demonstrating anidulafungin's superior potency versus existing
agents against a broad range of Candida species; -- A series of
pharmacokinetic studies demonstrating that anidulafungin can be
used in patients with potentially complicating conditions without
drug-drug interactions or hepatic (liver) toxicity; -- Results of a
Phase I clinical trial evaluating co-administration of
anidulafungin and voriconazole showed no sign of drug-drug
interactions and the regimen was well-tolerated; and -- Positive
data from a previously reported Phase II clinical trial
demonstrating the superior efficacy of once-weekly dalbavancin
versus vancomycin twice daily for the treatment of catheter-related
blood stream infections. "Vicuron's strong presence at this major
international meeting underscores our emerging leadership in the
hospital antifungal and antibiotic markets," said George F. Horner
III, President and Chief Executive Officer of Vicuron. "With
regulatory action on anidulafungin expected later this quarter,
these data presentations confirm the potential of anidulafungin to
become an important broad-spectrum, highly potent antifungal agent
for use in a wide range of patients. In addition, the complete
Phase II dalbavancin data in tough-to-treat bloodstream infections
is truly breakthrough as it is the first time any Gram-positive
injectable antibiotic has been shown to be superior to vancomycin
in these types of infections." The abstracts and oral presentations
are listed below: Anidulafungin 1. Sunday May 2 - 12:00-1:00 p.m.;
Poster Session I Comparison of the In Vitro Activity of
Anidulafungin with Amphotericin B, Caspofungin, Fluconazole,
Intraconazole and Voriconazole Against a Panel of 780 Yeasts
Obtained from Five European Centres, EM Johnson, BP Goldstein.
Poster #513. 2. Monday May 3 - 12:00-1:00 p.m., Poster Session
IIIAnidulafungin Pharmacokinetics are Not Affected by Concomitant
Voriconazole. J. Dowell, J. Schranz. Poster #1034. 3. Monday May 3
- 12:00-1:00 pm., Poster Session IIIPopulation Pharmacokinetics
Confirms Absence of Anidulafungin Drug-Drug Interactions. M.
Stogniew, J.A. Dowell. Poster #1035. 4. Monday May 3 - 12:00-1:00
p.m., Poster Session IIIAssessment of Pharmacokinetics of
Anidulafungin in Patients with Invasive Aspergillosis Receiving
Concomitant Liposomal Amphotericin B. J. Dowell, J. Schranz. Poster
#1036. 5. Tuesday May 4 - 1:00-2:00 p.m., Poster Session VI Lack of
Hepatic Effect of Anidulafungin. D. Krause, J. Schranz. Poster
#1789. Dalbavancin 1. Monday May 3 - 12:00-1:00 p.m., Poster
Session III Efficacy and Safety of Weekly Dalbavancin v. Vancomycin
in Catheter-related Bloodstream Infections (CRBSI). E. Seltzer, M.
Wible. Poster #934. 2. Monday May 3 - 12:00-1:00 p.m., Poster
Session III Evaluation of Dalbavancin Activity and Spectrum Tested
Against European Isolates. R.N. Jones, T.R. Fritsche. Poster #936.
3. Monday May 3 - 12:00-1:00 p.m., Poster Session III Once Weekly
Dalbavancin in Catheter-related Bloodstream Infections:
Microbiological Findings. B.P. Goldstein, R.N. Jones. Poster #935.
4. Monday May 3 - 12:00-1:00 p.m., Poster Session III Activity of
Dalbavancin Against European Clinical Isolates of Staphylococci and
Streptococci. R. Flamm, D. Draghi. Poster #932. 5. Monday May 3 -
12:00-1:00 p.m., Poster Session III In Vitro Anti-staphylococcal
and Anti-streptococcal Activity of Dalbavancin, Assessed by British
and NCCLS Methods. S. Mustaq, M. Warner. Poster #933. 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 species, 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 Dalbavancin
Dalbavancin, a novel next-generation glycopeptide agent, belongs to
the same class as vancomycin, the most widely-used and one of the
few treatments available to patients infected with the most
difficult-to-treat strains of Staphlococcus (Staph.): MRSA
(methicillin-resistant Staphylococcus aureus) and MRSE
(methicillin-resistant Staphylococcus epidermidis). Dalbavancin has
been specifically designed as an improved alternative to
vancomycin. In vitro studies have shown that in addition to being
potent against clinically important Gram-positive bacteria, it is
bactericidal (i.e., kills bacteria rather than merely inhibiting
their growth). The potency, tissue penetration and long half-life
of dalbavancin may allow for more flexible and convenient dosing
regimens than vancomycin. Dalbavancin may also help reduce the
length of hospital stays by decreasing the need for intravenous
lines that increase the risk of local and bloodstream infection. In
preclinical and clinical studies to date, dalbavancin appears to be
one of the most potent antibiotics in its class against MRSA and
MRSE and has not shown significant dose-limiting side effects.
Currently, once-weekly administration of dalbavancin is being
studied in multiple Phase III clinical trials of complicated and
uncomplicated skin and soft tissue infections. 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. DATASOURCE:
Vicuron Pharmaceuticals Inc. CONTACT: Dov A. Goldstein, M.D. of
Vicuron Pharmaceuticals Inc., +1-610-205-2312, or ; or Hala Bashir
of WeissCom Partners, +1-212-204-2080, or , or E. Blair Schoeb of
Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron
Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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