Cubist files novel antibiotic in Europe

A novel antibiotic combination from US company Cubist has been filed with the European Union regulator the EMA.

Cubist’s ceftolozane/tazobactam combination will be reviewed as a treatment of complicated urinary tract Infections (cUTI) and complicated intra-abdominal infections (cIAI). The firm says it now expects a decision from the European Commission in the second half of 2015. The drug is already under review in the US for this indication, with the FDA expected to make its ruling on 21 December.

New antibiotics are desperately needed around the world, as bacterial infections resistant to existing drugs become increasingly common, threatening to make some infections life-threatening once again.

Ceftolozane is a novel cephalosporin that has demonstrated potent in vitro activity against Pseudomonas aeruginosa, with tazobactam, a well-established beta-lactamase inhibitor. The addition of tazobactam broadens coverage to include most extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli), Klebsiella pneumoniae, and other Enterobacteriaceae.

The combination is also being developed for the potential treatment of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).

Cubist is headquartered in Lexington, Massachusetts, and has an international office in Zurich, Switzerland. It is one of a handful of companies specialising in developing and marketing new antibiotics for serious and life-threatening infections, and hopes to capitalise on US incentives (called GAIN and first introduced in 2012) to help make antibiotics a more commercially viable field. New strategic efforts to help fast-track drugs and create market incentives are also being developed through various projects in Europe, including via the Innovative Medicines Initiative (IMI) joint-working group.

Cubist aims to launch at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. Cubist expects to invest around $400 million in 2014 on antibacterial R&D and about 75% of its employee base is focused on the research, development, commercialisation, and support of antibiotics.

The company has already scored one hit this year – the approval in June of Sivextro in the US. Sivextro (tedizolid phosphate) is a novel oxazolidinone to treat susceptible Gram-positive pathogens including MRSA, one of the most notorious superbugs.

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UK review of antibiotics use ‘will take too long’

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