As takeover rumours begin to swirl again around Cubist Pharmaceuticals, the company says the European Medicines Agency has accepted its investigational antibiotic ceftolozane/tazobactam for review.
Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract and intra-abdominal infections, with a decision from the European Commission expected during the second half of 2015. The submission is based on data from two Phase III trials where the combo demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.
The drug has already been filed in the USA where it has a priority review. The Food and Drug Administration, which approved Cubist’s Sivextro (tedizolid) for serious skin infections in June, has set an action date of December 21.
News of the European filing has got observers looking at potential buyers for Cubist. Some of the names in the frame in the latest round of rumours are Pfizer, Johnson & Johnson and Eli Lilly, with a figure in the region of $7 billion being mentioned.