ARADIGM'S INHALED ANTIBIOTIC GRANTED ORPHAN DRUG STATUS

Aradigm has received orphan drug designation from the FDA for an inhaled liposomal formulation of ciprofloxacin for the management of bronchiectasis (BE). Aradigm previously received orphan drug designation for the same formulation of ciprofloxacin for the management of cystic fibrosis.

Aradigm's liposomal ciprofloxacin is an aerosolized formulation of this proven anti-infective drug that was designed to prolong its anti-infective properties in the lung in order to treat the related infections found in BE and cystic fibrosis patients while minimizing the concentration of the drug in the rest of the body, according to the company.

Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. As an orphan drug, liposomal ciprofloxacin is eligible for tax credits based on its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. The drug is currently in the preclinical stage of development. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of approval.