Cubist Pharmaceuticals Inc. (CBST:US) said its antibiotic for intra-abdominal infections met the goals of a second study and the company may file for regulatory approval in the U.S. and Europe next year. The shares rose in early trading.
The medicine, ceftolozane/tazobactam, proved to be statistically non-inferior to the antibiotic meropenem in curing the gram-negative infections, the Lexington, Massachusetts-based company said today in a statement. It was combined with another antibiotic, metronidazole, in the third of three phases of trials usually needed for regulatory approval.
The rate of side effects was similar for both regimens, with those taking the Cubist treatment experiencing nausea, diarrhea and fever, the company said. Cubist, which last month reported the compound showed a benefit in complicated urinary tract infections, plans to apply for approval in the U.S. in the first half of 2014 and in Europe in the second half.
“These data are encouraging as we face alarmingly increasing rates of bacterial resistance,” Philip S. Barie, a professor of surgery and public health at Weill Cornell Medical College, and a consultant to Cubist, said in the statement. “There is an urgent need for new antibiotics, especially in the hospital setting, in order to be able to manage effectively those conditions complicated by serious infections, including those caused by resistant gram-negative bacteria.”
Cubist gained 8.3 percent to $68 at 8:13 a.m. New York time. The shares gained 49 percent this year through last week.
In trial reported today, side effects occurred in 44 percent of patients on ceftolozane/tazobactam and 42.7 percent for those on meropenem, Cubist said.
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