Shares in Forest Laboratories were on the rise over the weekend after the group revealed plans to file a US marketing application for its antibiotic ceftaroline by the end of the year, following impressive results in clinical trials.

Two global, multi-centre Phase III clinical studies assessing ceftaroline for the treatment of community-acquired bacterial pneumonia (CABP) met their primary goal of demonstrating that the drug was at least as effective as the standard treatment ceftriaxone.

Furthermore, the results revealed that Forest’s antibiotic achieved high clinical cure rates in comparison, with integrated data from both studies showing a cure rate of 84.3% for the ceftaroline group versus 77.7% for those taking ceftriaxone.

The findings are important as CABP is a common cause of mortality and morbidity and an estimated 5.6 million cases of occur annually in the US alone, the firm notes. In addition, the condition places a significant burden on the healthcare system, causing an average 4.5 million visits to the doctor and 1.1 million hospitalisations and costing more than $10 billion every year. Treatment for CABP is primarily based on antibiotics but, as resistance to commonly-used antibiotics is on the rise, there is an urgent need for new and effective treatments.

Dirk Thye, president of Cerexa, the wholly-owned anti-infectives subsidiary of Forest, said the firm is “extremely pleased” with the results, which represent “a significant development milestone for ceftaroline”, and he added that “positive CABP Phase III clinical studies, along with the positive Phase III study results in CANVAS I and II, in complicated skin and skin structure infections, will serve as the basis for our New Drug Application, which we expect to file around calendar year-end”.