Aradigm's Pulmaquin Gets Fast Track Designation From FDA

Aradigm Corporation announced yesterday that its lead product candidate, Pulmaquin, has been granted Fast Track designation by the U.S. FDA for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE), a condition for which no approved treatment exists to date.

The Fast Track status provides several benefits to Aradigm to help get its drug to patients sooner, such as eligibility for priority review, access to the Rolling Review feature for its future NDA, and more frequent meetings with the FDA to ensure trial data is sufficient for drug approval. Pulmaquin was also granted the Qualified Infectious Disease Product (QIDP) designation earlier this year, which makes it eligible for certain incentives under the Generating Antibiotic Incentives Now Act (GAIN Act).

Juergen Froehlich, MD, CMO of Aradigm said, "The granting of Fast Track status is an important achievement that can facilitate accelerated review of an NDA submission based on the expected data from our current Phase 3 studies for Pulmaquin with the goal of bringing an important new treatment to these patients as quickly as possible."

Pulmaquin is currently being tested in two ongoing Phase 3 clinical trials (ORBIT-3 and ORBIT-4) for the non-CF BE indication in patients with chronic lung infections with Pseudomonas aeruginosa. The trials will determine the drug's safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-CF BE.

The drug is a dual release formulation consisting of ciprofloxacin in both liposome encapsulated and unencapsulated forms. Ciprofloxacin is a well-known broad-spectrum antibiotic used to treat acute lung infections, and Aradigm is focused on developing the inhaled formulation of ciprofloxacin for better efficacy.

Non-CF BE is a rare but severe respiratory disease which causes inflammation, recurrent lung infections, and bronchial wall damage. The condition affects more than 110,000 people in the U.S. and over 200,000 people in Europe, according to Aradigm. Non-CF BE is associated with high mortality and morbidity, and there is no drug approved yet for the treatment of this condition.

Since the past year, Aradigm has been moving quickly with its inhaled formulations of ciprofloxacin for non-CF BE and other indications. In Aug 2013, Aradigm granted an exclusive, world-wide license to Grifols for its inhaled liposomal ciprofloxacin product candidates. In September 2013, Aradigm signed a manufacturing partnership with Sigma-Tau Pharma Source, a biopharmaceutical CMO, for the clinical and commercial supply of Pulmaquin. Sigma-Tau PharmaSource has already been preparing the inhaled ciprofloxacin formulations for Aradigm's Phase 1 and studies.

Aradigm has already been granted orphan drug designations for liposomal ciprofloxacin for cystic fibrosis (CF) in the U.S. and the E.U., and also for the dual formulation of liposomal ciprofloxacin and ciprofloxacin for the management of bronchiectasis in the U.S.

Aradigm is also developing Pulmaquin and a liposomal ciprofloxacin formulation as potential medications for patients with chronic lung infections with non-tuberculous mycobacteria (NTM), and for the prevention and treatment of other respiratory infections, such as inhaled tularemia, pneumonic plague, Q fever, and inhaled anthrax.