Orphan drug status is given by the US regulators to compounds that can treat rare diseases, defined as those affecting fewer than 200,000 Americans. The designation gives the developer benefits such as a seven-year period of market exclusivity on approval and potential grant funding.
Michael Flavin, chairman and CEO of Advanced Life Sciences, said: “This designation will benefit us as we continue to build the cethromycin safety and efficacy database and will ultimately help position cethromycin as a potentially important antibiotic for the US government's strategic national stockpile.”
Advanced Life Sciences has established collaborations with US Army Medical Research Institute of Infectious Diseases and the National Institute of Allergy and Infectious Disease for the R&D of cethromycin against anthrax and other biowarfare agents.