ALS files cethromycin NDA for use in CAP

Chicago, USA-based Advanced Life Sciences has submitted a New Drug Application for cethromycin in mild-to-moderate community acquired pneumonia. The company also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. It affects 5.6 million patients in the USA each year, with 10 million physician visits and two million hospitalizations occurring annually.

The NDA is based on a full clinical development and manufacturing program for cethromycin. This included two global Phase III pivotal studies for the treatment of mild-to-moderate CAP in which the drug was dosed at 300mg once daily for seven days compared to the standard-of-care therapy, Biaxin7 (clarithromycin), which was used at 250mg twice daily for the same time period. The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile. The most common adverse reactions for cethromycin were taste disturbance, diarrhea, nausea and headache.