Forest planning NDA for ceftazidime/avibactam
On a conference call to discuss the financial results for its fiscal 3Q14, Forest Laboratories Inc. (NYSE:FRX) said it plans to submit an NDA for ceftazidime/avibactam ( CAZ-104) to treat complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) this summer. According to Forest, FDA said it will accept an NDA for the product -- a broad spectrum beta lactamase (LACTB) inhibitor combined with ceftazidime, a third-generation cephalosporin -- based on Phase II data.
Ceftazidime/avibactam -- which is in Phase III testing for cIAI and cUTI -- has Qualified Infectious Disease Product (QIDP) designation for the indications and for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). Forest has North American rights to co-develop and commercialize ceftazidime/avibactam from Novexel S.A., now part of AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury, Jan. 4, 2010). ...