Vicuron (NASDAQ:MICU)
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Vicuron Pharmaceuticals Announces Positive Pivotal Phase III
Results for Dalbavancin in Skin and Soft Tissue Infections
Company Plans to Submit NDA Later This Year as Planned
KING OF PRUSSIA, Pa., Aug. 12 /PRNewswire-FirstCall/ -- Vicuron
Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today announced
results from pivotal Phase III clinical trials comprising more than 1,500
patients evaluating once-weekly dalbavancin in skin and soft tissue infections
(SSTIs) caused by Gram-positive bacteria. All three studies met the primary
endpoint of non-inferiority in evaluable patients' clinical response at two
weeks following therapy when compared to linezolid, cefazolin or vancomycin,
the three most widely administered standard-of-care agents for SSTIs. All
studies also met the secondary endpoint of non-inferiority in clinical response
for the intent-to-treat (ITT) patient population. Dalbavancin was also shown to
be well tolerated.
"Based on this compelling data, we plan to file a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) later this year," said George
F. Horner III, Vicuron's president and chief executive officer. "We look
forward to working through the FDA to move this important new antibiotic toward
the market."
The vast majority of the patients treated in these studies had SSTIs caused by
Staphylococcus (Staph) aureus bacteria, with more than 400 patients infected
with methicillin-resistant Staphylococcus aureus (MRSA), one of the most
difficult-to-treat strains of bacteria. SSTIs are some of the most common
infections seen in the clinic and hospital. Postoperative surgical site
infections are one of the major sources of these infections.
"The consistent response versus standard of care we observed with dalbavancin
across all three studies is extremely encouraging," said Timothy J. Henkel, MD,
PhD, chief medical officer of Vicuron. "Dalbavancin has the potential to become
an important new agent in the physician's armamentarium to treat serious skin
and soft tissue infections caused by a broad spectrum of Gram-positive
bacteria."
Phase III Study Design and Results
-- Complicated SSTIs: Randomized, controlled, double-blind study of
854 patients versus linezolid. The primary endpoint was clinical
response at the follow-up visit in the evaluable patient population.
Evaluable patients taking dalbavancin demonstrated an 88.9 percent
response versus 91.2 percent for linezolid patients (95 percent
confidence interval -7.3, 2.9). In the ITT group, dalbavancin patients
showed a 76.5 percent response versus 82.7 for linezolid (95 percent
confidence interval -12.0, -0.3). Dalbavancin was well tolerated in
the study.
-- Uncomplicated SSTIs: Randomized, controlled, double-blind study of
565 patients versus intravenous cefazolin followed by oral cephalexin.
The primary endpoint was clinical response at the follow-up visit in
the evaluable patient population. Evaluable patients taking dalbavancin
demonstrated an 89.1 percent response versus 89.1 percent for cefazolin
(95 percent confidence interval -6.8, 6.8). In the ITT group,
dalbavancin patients showed a 76.0 percent response versus a
75.8 percent response for cefazolin (95 percent confidence interval
-7.7, 8.2). Dalbavancin was well tolerated in the study.
-- SSTIs caused by MRSA: Randomized, controlled, open-label study of
156 patients versus vancomycin in SSTIs suspected or confirmed to be
caused by methicillin-resistant Staphylococcus aureus (MRSA). The
primary endpoint was clinical response at the follow-up visit in the
evaluable patient population. Evaluable patients taking dalbavancin
demonstrated an 89.9 percent response versus 86.7 percent for
vancomycin (95 percent confidence interval -13.0, 19.4). In the ITT
group, dalbavancin patients showed an 86.0 percent response versus
65.3 percent for vancomycin (95 percent confidence interval 4.3, 37.0).
Dalbavancin was well tolerated in the study. This study is not pivotal,
but will be part of the NDA submission.
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
Staphylococcus (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.
Conference Call Information
Vicuron will host a conference call today, August 12 at 10:00 a.m. Eastern
Daylight Time. To access the live call or the 14-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 (800) 811-0667 (U.S. or Canada) or (913) 981-4901 (international)
to listen to the call. Telephone replay will be available beginning
approximately one hour after the call through September 12, 2004. To access the
replay, please call (888) 203-1112 (U.S. or Canada) or (719) 457-0820
(international). The conference ID number is 964098.
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. In May 2004, Vicuron
received an approvable letter from the FDA for its lead product anidulafungin
for the treatment of esophageal candidiasis. A Phase III study of anidulafungin
in invasive candidiasis is ongoing. 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
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 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 Mirza of WeissCom Partners,
+1-212-204-2080, or , for Vicuron Pharmaceuticals Inc.; or
Aline Schimmel of Burns McClellan, +1-212-213-0006, or ,
for Vicuron Pharmaceuticals Inc.
Web site: http://www.vicuron.com/