FRIMLEY, England, September 13 /PRNewswire/ --

- Physicians Welcome New Option for Potentially Life Threatening Disease

- Daptomycin has a Rapidly Bactericidal Mode of Action

The launch of daptomycin for the treatment of both
methicillin-sensitive and resistant Staphylococcus aureus (MSSA and MRSA)
bloodstream infections (bacteraemia) and heart infections (right-sided
infective endocarditis) has been announced today by Novartis Pharmaceuticals
UK Ltd.(1) Daptomycin, one of only two new classes of antibiotic in over 20
years, has been shown to be as effective as existing agents in treating a
range of serious Gram-positive infections, offering an important new option
for healthcare professionals.

MRSA is a frequent cause of bacteraemia and is associated with
serious complications, including endocarditis (in 30-40% of cases) and has a
high mortality rate.(2) Over 7,000 people each year contract bacteraemia and
the incidence is rising.(3) From 1993 to 2005 the number of deaths increased
from 51 to 1,629.(4) There is evidence that some strains of MRSA are 
developing resistance to existing antibiotic options.(5) Daptomycin, which is 
rapidly bactericidal, has a specific mode of action, which reduces the 
likelihood of resistance developing. Daptomycin's once daily dosing and 
tolerability profile, with no need for therapeutic drug monitoring, has the 
potential to simplify the management of patients with complicated infections.

Dr Andrew Seaton, consultant in infectious diseases, Gartnavel
general hospital, Glasgow welcomed the news, commenting; "Serious
staphylococcal infections are extremely challenging for hospital specialists
to treat, with about 40% in the UK now resistant to first line therapy.
Daptomycin is a fast acting agent in these potentially difficult situations
and is well tolerated by patients. This is an extremely important and
welcomed development in the battle against serious MRSA infection."

Daptomycin is already approved for the treatment of
complicated skin and soft tissue infections (cSSTI) caused by Staphylococcus
aureus and other Gram positive bacteria, including MRSA.(1) Clinical trials 
in cSSTI showed daptomycin had a faster time to cure (63% of patients
successfully treated with daptomycin achieved a clinical cure within four to
seven days versus 33% with comparators such as vancomyin and
anti-staphylococcal penicillins).(6)

Pivotal trial data published in The New England Journal of
Medicine supports the use of daptomycin in the treatment of bacteraemia and
endocarditis caused by MRSA. The head-to-head study demonstrated daptomycin
single agent therapy was as effective as dual agent comparator treatments and
also has a favourable safety and tolerability profile with more creatine
phosphokinase (CK) elevations but significantly fewer renal side effects
reported versus comparator treatments.(2) The favourable safety profile is an
important factor in severely ill patients.

A recent survey suggests that there is delay in patients receiving
appropriate treatment for MRSA in approximately 50% of cases.(7) Delaying
effective treatment for 48 hours can increase mortality as well as result in
longer hospital stays, thus increasing the burden on the healthcare
system.(8-11) Since Daptomycin is equally effective in treating MSSA and 
MRSA, it represents an important new empirical treatment choice for patients 
with MRSA bacteraemia associated with right sided endocarditis or complicated 
soft skin tissue infections.(2)

About the product

Daptomycin was first approved in the UK in March 2006 and
received a positive Scottish Medicines Consortium (SMC) recommendation for
its use in treating complicated skin and soft tissue infections (cSSTIs) in
March 2006.

Last month, The Committee for Medical Products for Human Use (CHMP) gave
extended approval to daptomycin for the use in right-sided infective
endocarditis (RIE) due to Staphylococcus aureus and Staphylococcus aureus
bacteraemia (SAB) when associated with RIE or with cSSTI.

Daptomycin is an antibiotic with a distinct mode of action
which has several notable features, including once-daily dosing and no
requirement for serum drug monitoring, which may reduce the burden on
healthcare professionals and hospitalisation costs.

About Novartis

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
approximately 100,000 associates and operate in over 140 countries around the
world. For more information, please visit http://www.novartis.com.

References

(1). Cubicin SPC, September 2007

(2). Fowler VG, Jr. et al. New Eng Jour med 2006;355(7):653-65

(3). Department of Health. MRSA surveillance system: Results.
Accessed on 18 July 2007. Available at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsSt
atistics/DH_4085951

(4). National Statistics Online. MRSA deaths continue to rise in
2005. Accessed on 18 July 2007. Available at:
http://www.statistics.gov.uk/cci/nugget.asp?id=1067

(5). Gould I, Editorial, International Journal of Antimicrobial
Agents, 30 (2007) 1-3

(6). Cubicin US prescribing information

(7). Ammerlaan H et al, Retrospective case-study analysis of
methicillin-resistant Staphylococcus aureus treatment pattern in Europe,
poster presentation ISCVID 2007

(8). Lodise TP,et al. Clin Infect Dis 2003;36:1418-1423

(9). Lodise TP, et al. Diagn Microbiol Infect Dis
2005;52:113-122

(10). Chang FY, et al. Medicine (Baltimore) 2003;82:322-332

(11). Laupland KB, et al. Crit Care Med 2004;32:992-997

Media contacts
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