Vicuron Pharmaceuticals Announces Positive Pivotal Phase III Results for Dalbavancin in Skin and Soft Tissue Infections
12 August 2004 - 5:40PM
PR Newswire (US)
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/
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