Aradigm Corporation has announced that it recently obtained two new patents providing coverage for formulations of liposomal and free ciprofloxacin in Europe (E.U. Patent No. 2079443) and Australia (AU2012211514). Both patents cover Aradigm’s lead product the inhaled ciprofloxacin drug Pulmaquin at least until 2027. Aradigm already has four issued U.S. patents and one Japanese patent providing coverage for Pulmaquin until 2031 and 2027, respectively.
“Long term patent protection of our lead product Pulmaquin is an important component of our corporate strategy” said Igor Gonda, president and chief executive officer of Aradigm. “Our global efforts in this area are running in parallel with our Phase 3 clinical trials of Pulmaquin for non-cystic fibrosis bronchiectasis currently being conducted across five continents in 14 different countries.”
Pulmaquin is a drug based on a dual release formulation of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin is a widely prescribed antibiotic, which is generally used to treat acute and chronic lung infections and has a broad-spectrum of antibacterial activity.
Pulmaquin is presently being evaluated for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) in patients suffering from chronic infection by the Pseudomonas aeruginosa bacteria. Non-CF BE is a severe, chronic and rare disease, frequently associated with chronic lung infection, and characterized by an abnormal dilatation of the bronchi and bronchioles. Non-CF BE has a high morbidity and mortality affecting more than 110,000 individuals in the U.S. and over 200,000 in Europe. There is no approved drug treatment for this disease.
The current Phase 3 clinical trials of Pulmaquin in non-CF BE patients aims at determining the safety and effectiveness of the drug as a once-a-day inhaled formulation. It involves two double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4), conducted worldwide with a similar design with the exception of a pharmacokinetics sub-study that will be conducted in one of the two trials. In total, each trial includes approximately 255 patients who will participate in a 48 week period experiment comprising treatment with either Pulmaquin or placebo every 28 days for 6 cycles, plus 28 days off treatment followed by a 28 day open label extension in which all patients will receive the drug. The safety of the drug will be determined by monitoring lung function.
Pulmaquin has been extensively tested in preclinical safety studies and Phase 2 trials with promising results and no significant clinical safety concerns. Last year, it also received the designation of Qualified Infectious Disease Product and Fast Track by the U.S. Food and Drug Administration.