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 that it has acquired the therapy Quinsair™ (levofloxacin inhalation solution) from Tripex Pharmaceuticals. The acquisition is important news for the cystic fibrosis community, as Quinsair is used to treat a serious bacterial lung infection common in many CF patients.
Quinsair is an antibiotic approved in Canada in June 2015 and in the European Union in March 2015, after the Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the commercialization of Quinsair (240 mg) as a therapeutic for adult patients with cystic fibrosis with recurrent infections by Pseudomonas aeruginosa. The company has also indicated that it will begin to discuss the path toward potential approval by the FDA in the U.S beginning in 2016. Quinsair is used for treating long-term lung infections caused by the bacteria Pseudomonas aeruginosa in adults who have cystic fibrosis. Cystic fibrosis is an inherited disease that causes an accumulation of thick mucus in the lungs that allows bacteria such as P. aeruginosa to grow more easily. Quinsair contains the active substance levofloxacin, a proven antimicrobial active against a wide range of gram negative and gram positive bacteria.
In addition to cystic fibrosis, Quinsair has development potential in two additional orphan diseases with significant unmet needs, bronchiectasis (BE) and nontuberculous mycobacteria (NTM) lung infections, for which there is a lack of treatment options.
“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.”
The acquisition of Quinsair was completed through Raptor’s entirely held subsidiary, Raptor Pharmaceuticals Inc.
Tripex received nearly $34.2 million in cash consideration with the product acquisition, subject to representation costs and warranty insurance payment deductions. In return, Raptor gains exclusive worldwide assets and rights to develop, manufacture and commercialize the drug formulation.