The European Commission approved Chiron’s intravenous antibiotic Cubicin yesterday for the treatment of complicated skin and soft-tissue infections caused by Gram-positive bacteria.
Chiron, which licenses the antibiotic from US company Cubist Pharmaceuticals, said it plans to launch Cubicin (daptomycin for injection) in the UK and the Netherlands within the next few weeks, followed by other European countries.
The approved indication covers a range of serious infections, usually occurring in hospitalised patients, including major abscesses, post-surgical skin wound infections and infected ulcers.
Cubicin is the first cyclic lipopeptide antibiotic to reach the market, and has been sold in the USA since November 2003. It is also available in Israel and Argentina. Cubist reported Cubicin sales of $114 million in 2005, a rise of 94% year-on-year.
Cubicin’s mechanism of action means it is unaffected by the high-level cross-resistance that occurs with many other antibiotic classes, according to Chiron.
The antibiotic is one of three that have been tipped to grow strongly over the coming years as a result of the increasing prevalence of drug-resistant pathogens, according to a market report released in December by Decision Resources. The others are Pfizer’s Zyvox (linezolid) and Sanofi-Aventis’ Ketek (telithromycin; which hit the headlines itself yesterday after being linked to liver toxicity in a journal report.)
For Cubicin, the key driver for growth will be the growing incidence of methicillin-resistant Staphylococcus aureus (MRSA) infections in hospitals and the community setting, according to DR.
Infective endocarditis
Meanwhile, Cubicin will be discussed at a US Food and Drug Administration (FDA) advisory committee meeting on March 6 for a new indication, the treatment of patients with bacteraemia with known or suspected endocarditis caused by S aureus.
Last November, Cubist was granted a fast-track review for this indication by the FDA, although the agency’s Anti-Infective Drugs Advisory Committee gave only lacklustre support to the proposal at a meeting in October.
