Cubicin® receives European approval to expand use to treating two
additional types of life-threatening hospital infections
* Cubicin approved for treating two more life-threatening
Staphylococcus aureus infections: right-sided infective
endocarditis (RIE) and certain bacteremias
* Cubicin clinically proven to target both Staphylococcus aureus
and methicillin-resistant Staphylococcus aureus (MRSA) with equal
* These serious infections can cause death in up to one-third of
patients if not treated quickly and effectively
Basel, September 5, 2007 - Cubicin® (daptomycin) has received
European Commission approval for expanded use in helping patients
suffering from two types of life-threatening bacterial infections
that commonly occur during hospital stays, including infections
caused by methicillin-resistant Staphylococcus aureus (MRSA) strains.
The two new indications approved for Cubicin were right-sided
infective endocarditis (RIE) due to Staphylococcus aureus (S.
aureus), an infection of the heart valve, and S. aureus bacteremia
(SAB), a bloodstream infection, in cases when associated with RIE or
with complicated skin and soft-tissue infections (cSSTI).
Cubicin first received European approval in January 2006 for use in
treating cSSTI infections caused by Gram-positive bacteria.
In the UK alone, more than 15,000 patients are estimated to contract
SAB infections every year. If not quickly and effectively treated,
up to one-third of these patients may die from the infections.
With growing resistance to current treatments, these types of
infections are becoming an increasingly serious public health
The use of Cubicin in treating patients with bacteremia and
endocarditis caused by S. aureus has been supported by landmark trial
data published in The New England Journal of Medicine.
A head-to-head study demonstrated that Cubicin was equally effective
against both methicillin-susceptible and methicillin-resistant S.
aureus bloodstream infections. Results also showed Cubicin
successfully treated patients with SAB or RIE infections with the
same efficacy as the current standards of care, which is vancomycin
or semi-synthetic penicillin combined with initial gentamicin
therapy. Additionally, impaired kidney function, a common side-effect
of antibiotics used to treat these infections, was significantly
lower in patients receiving Cubicin than in those treated with the
"With the growing rates of MRSA infections, the need to treat
patients quickly - even before the infecting organism can be
confirmed - is strong. Daptomycin can be used empirically to cure
both methicillin-susceptible Staphylococcus aureus and MRSA
infections," said Dr. Christoph Naber, Assistant Medical Director of
the Department of Cardiology at the University of Duisburg-Essen and
founding member of the German League for Infectious Diseases.
"Daptomycin was proven to treat both infections with equal efficacy
and overall favorable safety and tolerability."
As the first in a new class of antibiotics called cyclic
lipopeptides, Cubicin rapidly resolves serious Gram-positive hospital
infections with a unique mode of action, killing bacteria rather than
limiting growth, resulting in negligible bacterial cell lysis.
This means that dead bacteria are left intact, preventing them from
releasing their toxic contents into the bloodstream.
While the current standard of treatment often requires combination
therapies, Cubicin is a simpler approach to Gram-positive infections
as a once-daily monotherapy that requires no routine therapeutic drug
"Expanding the use of Cubicin for additional life-threatening
infections signals our commitment to the challenges of increasing
resistance to many antibacterials in the hospital setting," said
James Shannon MD, Global Head of Development at Novartis Pharma AG.
"Cubicin offers physicians an effective and well-tolerated
therapeutic option that can be used quickly and easily to help
patients begin recovery rapidly."
Cubicin was developed by, and is a registered trademark of, Cubist
Pharmaceuticals, Inc., which markets the product in the US for the
treatment of complicated skin and skin structure infections and S.
aureus bacteremia, including right-sided endocarditis. Novartis has
the exclusive rights to commercialize Cubicin across Europe,
Australia, New Zealand, India, and certain countries in Central
America, South America and the Middle East.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can," "may," or similar
expressions, or by express or implied discussions regarding potential
new indications or labelling for Cubicin or regarding potential
future revenues from Cubicin. Such forward-looking statements reflect
the current views of the Novartis group of companies regarding future
events, and involve known and unknown risks, uncertainties and other
factors that may cause actual results with Cubicin to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that Cubicin will be approved for any additional indications or
labelling in the EU or any other market, nor can there be any
guarantee that Cubicin will achieve any particular sales levels. In
particular, management's expectations regarding Cubicin could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; the company's ability
to obtain or maintain patent or other proprietary intellectual
property protection; competition in general; government, industry and
general public pricing pressures, and other risks and factors
referred to in Novartis AG's Form 20-F on file with the US Securities
and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2
billion. Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ
more than 100,000 associates and operate in over 140 countries around
the world. For more information, please visit
 Fowler VG, Jr., Boucher HW, Corey GR, et al. Daptomycin versus
standard therapy for bacteremia and endocarditis caused by
Staphylococcus aureus. The New England journal of medicine
 Cosgrove SE, Sakoulas G, Perencevich EN, Schwaber MJ, Karchmer
AW, Carmeli Y. Comparison of mortality associated with
methicillin-resistant and methicillin-susceptible Staphylococcus
aureus bacteremia: a meta-analysis. Clin Infect Dis 2003;36(1):53-9.
 Health Protection Agency. Bacteremia - Staphylococcus aureus
bacteremia: voluntary reporting in England, Wales and Northern
Ireland: January to December 2005. CDR Weekly 2006:16(33): 4.
 Ginsburg I. The role of bacteriolysis in the pathophysiology
of inflammation, infection and post-infectious sequelae. Apmis
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