EMA prepares to review new Cubist antibiotic
- In addition to being reviewed by the European Medicines Agency (EMA), Cubist’s combo antibiotic (ceftolozane/tazobactam) for the treatment of complicated urinary tract and intra-abdominal infections is also being reviewed by the FDA.
- The company is submitting the application based on the results of two phase III trials evaluating ceftolozane/tazobactam against aggressive gram-negative bacteria.
- There are a swirl of buy-out rumors surrounding Cubist, with some saying that potential buyers may include Pfizer, Eli Lilly, and Johnson & Johnson.
The FDA has set an action deadline of December 21 for Cubist's antibiotic combo, while an EMA decision is expected by the second half of 2015.
Some of the gram-negative bacteria that ceftolozane/tazobactam has shown to fight include Pseudomonas aeruginosa, Escheria coli, and Klebsiella pneumoniae, among others. This drug is intended to be used to treat patients with serious infections.
Rumors of a potential takeover/buy-out of Cubist have estimated a target price in the $7 billion range, despite Cubist's current market cap of approximately $5 billion -- a sign of the company's promising pipeline.
- Pharma Times EMA to review new Cubist antibiotic