Vicuron (NASDAQ:MICU)
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Vicuron Pharmaceuticals Announces Data at ICAAC Demonstrating
Potency of Anidulafungin and Dalbavancin
KING OF PRUSSIA, Pa., Nov. 1 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals
Inc. (Nasdaq: MICU; Nuovo Mercato) today announced details of oral and poster
presentations on its lead antifungal anidulafungin and lead antibiotic
dalbavancin at the 44th Annual Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC) meeting in Washington, D.C.
Highlights of data presented on anidulafungin and dalbavancin at ICAAC include:
- In vitro data demonstrating dalbavancin's potency against a broad range
of Gram-positive bacteria, including methicillin resistant
Staphylococcus aureus (MRSA);
- An oral presentation demonstrating anidulafungin's in vitro activity
shows anidulafungin is more potent than fluconazole against Candida
albicans biofilms, which are difficult-to-treat hospital acquired
infections; and
- Clinical data on anidulafungin's efficacy against azole-refractory
mucosal candidiasis.
"The dalbavancin data demonstrate its potent in vitro activity against recent
clinical isolates of Staphylococci and Streptococci in a large international
survey, further supporting the efficacy seen in our Phase 3 skin and soft
tissue infection studies," said Timothy J. Henkel, M.D., Ph.D., Chief Medical
Officer of Vicuron. "Anidulafungin's activity against Candida in a biofilms
model is particularly interesting because this is a common and
difficult-to-treat source of infection from catheters and medical devices."
Biofilms are a community of microorganisms, such as bacteria or yeasts, which
grow in an extracellular matrix attached to a solid surface. Biofilms play a
major role in the infection of intravenous catheters, medical devices and
implanted prosthetic material. Bacteria or fungi growing in biofilms often are
highly resistant to drug therapy, and may require high doses of antimicrobial
drugs, long-term therapy, or even removal of the catheter or device for
successful treatment.
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.
About Dalbavancin
Dalbavancin, a novel second generation lipoglycopeptide 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 also may 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.
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 the pipeline may not
yield a new clinical candidate or a commercial product, 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 Mirza 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/