Orphan drug status may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 persons in the US. Such designation provides a company with seven years of marketing exclusivity for a selected drug approved by the FDA along with regulatory assistance, reduced filing fees and possible tax credits.
The clinical program for the drug will investigate the pulmonary delivery of the novel formulation of this widely used anti-infective for its local and prolonged effects in the treatment of bacterial infections in cystic fibrosis (CF).
Aradigm’s liposomal formulation is designed to change the short-acting nature of ciprofloxacin so that it becomes long-acting and remains in the lung for a sufficient amount of time to treat pseudomonas infections commonly found in patients with CF.
“We believe that liposomal ciprofloxacin could play an important role in improving the quality of life of patients with cystic fibrosis,” said Dr Babatunde Otulana, vice president of clinical and regulatory affairs at Aradigm. “Aradigm will advance this program through development and utilize the financial and regulatory benefits that orphan drug status provides.”