Raptor Pharmaceutical Corp., a global biopharmaceutical company focused on the development and commercialization of transformative therapeutics for rare, debilitating and often fatal diseases, recently announced it has acquired the rights to Quinsair™ (levofloxacin inhalation solution) from Tripex Pharmaceuticals. Quinsair is the first inhaled fluoroquinolone antibiotic to be approved in the European Union and in Canada as a treatment for chronic respiratory infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis.
Cystic Fibrosis (CF), a life-threatening disease affecting approximately 70,000 people worldwide, is characterized by progressive lung function decline. The disease is caused by mutations in the Cftr gene (cystic fibrosis transmembrane conductance regulator gene). The CFTR protein is responsible for trafficking chloride and sodium ions in and out of cells of lungs and intestinal epithelium, and so in the absence of CFTR functional protein, thick mucus accumulates, making CF patients more susceptible to infections.Pseudomonas aeruginosa is the most common organism that causes lung infections in CF patients, and targeted therapies against this strain of bacteria such as Quinsair have significantly improved patients’ outcomes.
“The acquisition of Quinsair adds another significant product to our rare disease franchise,” stated Julie Anne Smith, president and CEO of Raptor. “We are excited about our plans to launch the drug in Europe and Canada beginning in the first half of 2016, initiate a clinical program in 2016 in at least one of nontuberculous mycobacteria and/or bronchiectasis and engage with the FDA regarding a path to potential approval in the U.S. in cystic fibrosis.”
Quinsair is delivered to the lungs in high concentrations through the eFlow Nebulizer System (PARI Pharma GmbH), allowing the drug to effectively reach the site of infection in about five minutes. Quinsair is not recommended in patients known to have hypersensitivity to levofloxacin, a history of tendon disorders related to fluoroquinolones, epilepsy, or who may be pregnant or breast feeding. Quinsair’s safety was determined in two double-blind, placebo-controlled studies and in an active comparator study which noted common, transient adverse reactions, including cough/productive cough, dysgeusia and fatigue/asthenia.
While Quinsair is currently not approved in the United States, Raptor has indicated that the company will be discussing a path toward eventual FDA approval in 2016 to accompany the drug’s availability in the European Union and Canada.