Aradigm Gets FDA Orphan Drug Designation for Ciprofloxacin for Inhalation in Bronchiectasis

Aradigm Corporation today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for ciprofloxacin for inhalation for the management of bronchiectasis (BE).

Previously, Aradigm received orphan drug designations from FDA for liposomal ciprofloxacin for inhalation for the management of bronchiectasis and for liposomal ciprofloxacin for the management of cystic fibrosis.

“We are very pleased that FDA has granted Aradigm this new orphan drug designation for bronchiectasis which provides additional incentive for our Company to develop a much needed therapeutic tool for this significant unmet medical need in respiratory medicine,” said Igor Gonda, President and CEO.

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 a designated orphan drug, Aradigm’s ciprofloxacin drug candidates are eligible for tax credits based upon their clinical development costs, as well as assistance from the FDA in guiding the drug candidates through the regulatory approval process. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of NDA approval.

About bronchiectasis

Bronchiectasis (BE) is a progressive lung disease in which the airway walls are chronically inflamed. This is often the result of a vicious cycle of bacterial infection, in which damage to the lungs further predisposes the lung to more infections. The body repairs the damaged lung tissue by forming tough, fibrous material, which leads to changes that impair normal lung structure and function. Recurrent lung infections reduce the patient’s quality of life and progressive respiratory insufficiency is the most common cause of death. The colonization of the lung with the microorganism Pseudomonas aeruginosa is associated with the severity of BE. Exacerbations in this patient population often require hospitalization and administration of intravenous antibiotics. BE is frequently observed in patients with cystic fibrosis (CF), however, it is a condition that affects about 110,000 people without CF in the United States and many more in other countries. There is currently no drug specifically approved for the treatment of this condition in the U.S.

About liposomal ciprofloxacin

Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients. The Company’s novel inhaled ciprofloxacin formulations are designed for once daily dosing. The Dual Release Ciprofloxacin for Inhalation (DRCFI, ARD-3150, Pulmaquin(TM)) contains liposomally encapsulated Ciprofloxacin for Inhalation (CFI, ARD-3100, Lipoquin(TM)) mixed with a solution of free ciprofloxacin for inhalation. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The Company previously reported positive results from its 6-month Phase 2b study (ORBIT-2) with Aradigm’s Pulmoquin (ARD-3150, DRCFI) and other Phase 2a studies of 22 CF patients and 36 BE patients who received Lipoquin (CFI, ARD-3100) once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The Company announced in March 2011 that the last patient was enrolled for the ORBIT-1 study in BE patients treated with Lipoquin or placebo for 28 days, with a 28 day follow-up period of no study drug treatment, The Company is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.

Source: Business Wire