Cubist gains on Phase III data for ceftolozane/tazobactam

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) said IV ceftolozane/tazobactam (formerly CXA-201) every eight hours for seven days met both the FDA-defined primary endpoint and the EMA-defined primary endpoint in pooled data from 1,050 patients in a pair of identical, double-blind Phase III trials to treat complicated urinary tract infection (cUTI). The FDA-defined primary endpoint was non-inferiority to IV levofloxacin in the proportion of patients in the modified microbiological intent-to-treat (mMITT) population who achieve both microbiological eradication and clinical cure at 5-9 days after end of therapy. The EMA-defined primary endpoint was non-inferiority to levofloxacin in the proportion of patients who achieved microbiological eradication in the mMITT population. The news sent Cubist up $5.26 to $70.76 on Monday.

In late December, Cubist plans to report data from a pair of Phase III trials evaluating ceftolozane/tazobactam to treat complicated intra-abdominal infections (cIAI). Next half, the company plans to submit an NDA to FDA, with an MAA to EMA "shortly thereafter" for the product to treat both cUTI and cIAI. Also next half, Cubist plans to start a Phase III trial of ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The product has Qualified Infectious Disease Products (QIDP) designation from FDA for all four indications, which would entitle Cubist to an additional five years of market exclusivity if it is approved. ...