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Novartis Pharmaceuticals UK Limited (NVS) New License for Cubicin(R) (daptomycin), the First in a Novel Class of Antibiotic Announced Today


9/13/2007 8:11:30 AM

FRIMLEY, England, September 13 /PRNewswire-FirstCall/ --

- 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 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 Sally Irvine Novartis Communications UK +44-1276-698-691 (Press Office) +44-7966-118-688 (mobile) Sally.irvine@novartis.com Jo Crouch ShireHealth PR 121-141 Westbourne Terrace London, W2 6JR UK +44-207-108-6067 e-mail: jo.crouch@shirehealthpr.com Sabrina Gallon ShireHealth PR 121-141 Westbourne Terrace London, W2 6JR UK +44-207-108-6084 e-mail: Sabrina.gallon@shirehealthpr.com

Novartis Pharmaceuticals UK Ltd

CONTACT: Media contacts: Sally Irvine, Novartis Communications UK,+44-1276-698-691(Press Office), +44-7966-118-688 (mobile),Sally.irvine@novartis.com; Jo Crouch, ShireHealth PR, 121-141 WestbourneTerrace, London, W2 6JR, UK, +44-207-108-6067, e-mail:jo.crouch@shirehealthpr.com; Sabrina Gallon, ShireHealth PR, 121-141Westbourne Terrace, London, W2 6JR, UK, +44-207-108-6084, e-mail:Sabrina.gallon@shirehealthpr.com



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