Raptor Pharmaceutical Corp., a biopharmaceutical company focused on therapeutics for rare, debilitating diseases, recently reported that it has acquired exclusive global rights and assets to develop, manufacture and commercialize Quinsair™ (levofloxacin inhalation solution) from Tripex Pharmaceuticals.
Quinsair is an inhaled formulation of levofloxacin, a broad-spectrum antibiotic of the fluoroquinolone drug class. It was the first inhaled fluoroquinolone antibiotic to be approved in Canada and the European Union as a therapy for chronic pulmonary infections linked to Pseudomonas aeruginosa in adults with cystic fibrosis, a life-threatening genetic disease that causes the body to form unusually thick, sticky mucus that can obstruct the airways and promote dangerous lung infections.
Quinsair is administered through an eFlow Nebulizer System (PARI Pharma GmbH), which delivers a high concentration of the active drug directly in the site of infection. The most common reported adverse events associated with Quinsair treatment are fatigue/asthenia (lack of energy), cough and dysgeusia (abnormal taste).
“The acquisition of Quinsair adds another significant product to our rare disease franchise,” stated the president and CEO of Raptor, Julie Anne Smith, in a press release. “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.”
Raptor is planning to develop Quinsair not only for cystic fibrosis but also for nontuberculous mycobacteria (NTM) or bronchiectasis, a respiratory condition characterized by a chronic inflammation that usually results from an infection or other condition that injures the walls of the airways, causing irreversible airway dilatation and scarring. In bronchiectasis, the airways slowly lose their ability to clear out mucus, so it accumulates in the lungs, creating an environment prone to bacteria growth that can lead to severe lung infections. Sputum production, chronic cough and recurrent chest infections are signs of the disease.
Under the terms of the agreement, Raptor paid Tripex around $34.2 million in cash consideration as well as in shares of Raptor common stocks. Contingent payments of up to $350 million are dependent on the achievement of development, regulatory and commercial milestones. Royalties on future global net sales are also included in the agreement.