Aradigm’s cystic fibrosis drug candidate gets orphan status

Aradigm’s liposomal ciprofloxacin is an aerosolized formulation of this proven anti-infective drug that was designed to increase the drug’s residence time in the lung and prolong its anti-infective properties in order to treat the related infections found in cystic fibrosis patients.

“This designation for liposomal ciprofloxacin provides us the opportunity to help accelerate our efforts behind this innovative product,” said Dr Babatunde Otulana, senior vice president of clinical and regulatory affairs at Aradigm. “We appreciate the multiple financial and strategic benefits that this status provides us in developing this application for an area of unmet medical need.”

Orphan drug designation is intended to encourage R&D of new therapies for diseases that affect fewer than 200,000 patients in the US. As a designated orphan drug, liposomal ciprofloxacin is eligible for tax credits based upon its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of NDA approval.

CF is a genetic disease affecting approximately 30,000 children and adults in the US and about 60,000 worldwide. The defective gene causes production of excess mucus that clogs the lungs and often leaves patients vulnerable to life-threatening lung infections.