Advanced Life Sciences, Inc. (NASDAQ:ADLS), an Illinois based biopharmaceutical company, today announced submission of a new drug application (NDA) for its lead product, cethromycin, a unique once-a-day antibiotic for respiratory tract infections. The NDA submission is for cethromycin in mild-to-moderate community-acquired pneumonia (CAP). Community-acquired pneumonia is the sixth most common cause of death in the U.S., affecting 5.6 million Americans annually. The company is focusing its resources on the development and commercialization of cethromycin for use in respiratory tract infections such as community-acquired pneumonia, bronchitis, and sinusitis.
Penicillins and macrolides are currently the most common treatment for CAP, but increasing resistance has driven the need for new antibiotics. CEO Michael Flavin, Ph.D., said, “We look forward to advancing the cethromycin NDA through the FDA review process.” The NDA submission is based on a full clinical development and manufacturing program for cethromycin. More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.
In addition, Advanced Life Sciences and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), have signed a development and commercialization agreement for cethromycin in the Asia Pacific region, excluding Japan. Advanced Life Sciences will retain exclusive rights to cethromycin in the rest of the world, including North America and Europe.
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs in the areas of infection, cancer, and respiratory disease. Although cethromycin is the company’s lead product, they have a promising pipeline of clinical and preclinical candidates, with three product candidates that are either in clinical development or approved to begin clinical development, as well as six additional candidates in preclinical development.
In conjunction with the NDA submission, Advanced Life Sciences has received a commitment to increase availability under its loan facility with Leaders Bank from $4 million to $10 million. The company also plans to partner with other organizations to advance its earlier stage programs.
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