Vicuron Pharmaceuticals Completes Enrollment in Phase III Clinical Trials of Dalbavancin for Skin and Soft Tissue Infections
May 11 2004 - 7:30AM
PR Newswire (US)
Vicuron Pharmaceuticals Completes Enrollment in Phase III Clinical
Trials of Dalbavancin for Skin and Soft Tissue Infections
Comprehensive Phase III Development Program Designed to Support
U.S. NDA Filing in Late 2004 KING OF PRUSSIA, Pa., May 11
/PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq:
MICU; Nuovo Mercato: MICU) today announced that it completed
enrollment in three Phase III clinical trials involving over 1,500
patients designed to support registration of once-weekly
dalbavancin for the treatment of skin and soft tissue infections
(SSTIs). Vicuron expects to announce data from these studies in the
second half of 2004 and file a New Drug Application for dalbavancin
with the U.S. Food and Drug Administration by the end of 2004.
"Vicuron completed enrollment in this comprehensive Phase III
clinical development program for dalbavancin ahead of schedule,"
said George F. Horner III, President and Chief Executive Officer of
Vicuron. "This important milestone achievement underscores our
commitment to the therapeutic category and to demonstrating the
benefits of our powerful and unique antibiotic, which we believe
has significant advantages over currently available agents. With
our first product candidate anidulafungin, a novel anti-fungal
agent, awaiting a final FDA decision soon, and a regulatory filing
expected for dalbavancin later this year, we are focused on
becoming a leader in the hospital market." Phase III Program
Details -- Complicated SSTIs: Randomized, controlled, double-blind
study. Patients receive either intravenous dalbavancin or linezolid
for 14 days. The primary endpoint is overall clinical and
microbiological response at the conclusion of therapy. --
Uncomplicated SSTIs: Randomized, controlled, double-blind study.
Patients receive either intravenous dalbavancin or intravenous
cefazolin, followed by oral cephalexin. The primary endpoint is
overall clinical and microbiological response at the conclusion of
therapy. -- SSTIs caused by MRSA: Randomized, controlled,
open-label study of patients with SSTIs suspected or confirmed to
be caused by methicillin-resistant Staphylococcus aureus (MRSA).
Patients receive either two doses of intravenous dalbavancin one
week apart or twice daily doses of intravenous vancomycin for 14
days. The primary endpoint is an assessment of clinical response at
the time of follow-up visit. 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. 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, including 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 , for
Vicuron Pharmaceuticals Inc.; or E. Blair Schoeb of Burns McClellan
Inc., +1-212-213-0006, or , for Vicuron Pharmaceuticals Inc. Web
site: http://www.vicuron.com/
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