European Commission has granted marketing approval for Chiron's Cubicin (daptomycin), a first-in-class IV antibiotic. The marketing approval was granted in the 25 member states of the European Union, Iceland, Liechtenstein and Norway.

Under the approval, Cubicin is indicated for the treatment of complicated skin and soft-tissue infections (cSSTI) caused by Gram-positive bacteria. Cubicin is expected to become available in the United Kingdom and the Netherlands within the next few weeks, followed by additional European countries, in accordance with local legal regulations, states a Chiron release.

Gram-positive bacteria are a major cause of problematic infections in many healthcare facilities and institutions. Of particular concern are methicillin-resistant Staphylococcus aureus (MRSA), glycopeptide-intermediate S. aureus (GISA) and glycopeptide-resistant enterococci (VRE or GRE), particularly E. faecium, which are driving the need for new antibacterial agents. The use of Cubicin is supported by clinical data from two pivotal phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of Cubicin in the treatment of cSSTI. These trials demonstrated that Cubicin was as effective as standard therapy in this indication.

"The launch of Cubicin in Europe provides an important new alternative in the treatment of serious skin infections, which are increasingly resistant to standard drug therapies," said Craig Wheeler, president of Chiron BioPharmaceuticals.

Chiron licensed development and commercialisation rights to Cubicin in the European Union from Cubist, which launched Cubicin in the United States in November 2003.

Mike Bonney, president and CEO of Cubist, said, "European market approval helps to validate the potential of Cubicin, our first-in-class lipopeptide antibiotic, worldwide. The news today is also a reflection of our solid working relationship with Chiron."

Cubicin is the first of a new class of antibiotics called cyclic lipopeptides. Its mechanism of action, distinct from any other antibiotic, involves binding to the cell membrane of Gram-positive bacteria, causing depolarization and leading to inhibition of protein, DNA and RNA synthesis. This results in bacterial cell death.