Cubist Pharmaceuticals Inc., a drug maker with $1.1 billion in 2013 revenue and 600 employees at its Lexington headquarters, said Monday that it has filed a new drug application with US regulators for a drug candidate designed to treat complicated urinary tract infections and complicated intra-abdominal infections.
The application to the US Food and Drug Administration is for an antibiotic called ceftolozane/tazobactam, the company said in a press release. Cubist added that it expects to file a similar application with European regulators in the second half of this year.
Last fall, Cubist reported positive clinical trial results for ceftolozane/tazobactam. A Globe story noted that this drug candidate targets a potentially large market.
In the United States, urinary tract infections account for nearly 10 million doctor visits a year, a company spokeswoman noted in an e-mail. As for complicated intra-abdominal infections, they also are a common problem, with appendicitis alone affecting over 300,000 patients per year and consuming over 1 million hospital days in the US, she added.
The company’s focus is predominantly on antibiotics, and it said it expects to invest roughly $400 million in 2014 on antibacterial research and development as it looks to escalate the battle against so-called superbugs, which resist today’s antibiotics.
The company’s biggest product is Cubicin, an antibiotic for the treatment of complicated skin infections as well as bloodstream infections caused by bacteria including MRSA. In 2013, Cubicin accounted for roughly 80 percent of Cubist’s revenue.
Just about three weeks ago, meanwhile, an FDA advisory panel recommended that the agency approve Sivextro, another Cubist drug candidate, this one designed to treat serious bacterial skin infections. Although the FDA is not bound by such recommendations, it often relies heavily on the conclusions of its advisory panels.