EMA Accepts Cubist's MAA for Ceftolozane/Tazobactam
By C. Rajan, contributing writer
The European Medicines Agency (EMA) has accepted for review Cubist Pharmaceuticals' Marketing Authorization Application (MAA) for ceftolozane/tazobactam, an investigative antibiotic for the treatment of complicated urinary tract Infections (cUTI) and complicated intra-abdominal infections (cIAI). The company is expecting a decision from the European Commission (EC) during the second half of 2015. The U.S. FDA has already accepted Cubist's New Drug Application (NDA) for ceftolozane/tazobactam under Priority Review, and has assigned an action date of December 21, 2014.
Ceftolozane/tazobactam consists of ceftolozane, a novel cephalosporin with potent in vitro activity against Pseudomonas aeruginosa, in combination with tazobactam, a beta-lactamase inhibitor. Ceftolozane/tazobactam is also being developed to treat hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
Cubist's submissions for ceftolozane/tazobactam in Europe and the U.S. were made following positive results from two pivotal Phase 3 clinical trials in cUTI and cIAI indications. These studies met both the EMA and U.S. FDA specified primary endpoints. In the clinical trials, ceftolozane/tazobactam was effective in battling several problematic Gram-negative bacteria in patients with complicated infections.
"We are pleased to receive MAA acceptance for ceftolozane/tazobactam and look forward to working with the EMA on this important review," said Steven Gilman, Ph.D., EVP of Research and Development and CSO of Cubist. "As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria."
The antibiotic candidate was designated as a Qualified Infectious Disease Product (QIDP) by the FDA in 2013, according to the Generating Antibiotic Incentives Now (GAIN) Act, for its potential indications of cUTI and cIAI. The QIDP designation provides incentives such as eligibility for Fast Track status, Priority Review, and a five year extension of marketing exclusivity after FDA approval.
Cubist is focused on developing novel antibiotics to treat infections caused by a broad range of increasingly drug-resistant bacteria. According to the company's press release, it expects to invest approximately $400M in 2014 on antibacterial R&D. The company is on track to meet its goal of delivering at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020.
The company already has a blockbuster drug, Cubicin, a daily injection to treat Methicillin-resistant Staphylococcus Aureus (MRSA) infections that generates more than $1 billion. Cubist's recently launched Sivextro (Tedizolid phosphate), indicated for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI), is estimated to bring in annual sales of over $300 million.
Cubist's commitment to developing antibiotics makes it an attractive prospect for takeover by companies like Pfizer, Eli Lilly or Johnson and Johnson, who might be enticed by the GAIN Act of 2012 to enter the antibiotics market, Bloomberg reports. Industry analysts estimate that Cubist will be making over $2 billion in revenue by 2018.