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Raptor Pharmaceutical Launches QUINSAIR™ in Europe

NOVATO, Calif., April 11, 2016 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (RPTP) today announced its first commercial sale of QUINSAIR™ (levofloxacin inhalation solution) in Germany and Denmark. QUINSAIR is approved in the European Union (EU) and Canada for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF). It is the first fluoroquinolone to be approved as an inhaled therapy for a pulmonary disease. The treatment is administered twice-daily, stored at room temperature and has a short administration time. Launches in additional EU countries and Canada are anticipated for QUINSAIR in 2016.

Dave Happel, Raptor’s Chief Commercial Officer, said, “Raptor is excited to offer a new, first-in-class inhaled antibiotic treatment option for the many patients and families living with cystic fibrosis and battling chronic bacterial lung infections. We are beginning the European launch of QUINSAIR in Germany and Denmark, and continue to pursue approval of QUINSAIR for CF patients in the United States.”

Happel added, “We are confident that QUINSAIR will be an important growth driver for Raptor. We expect QUINSAIR to increase our revenue base and enhance our long-term growth profile while leveraging our commercial and development expertise and our existing global infrastructure.”

About QUINSAIRTM (levofloxacin inhalation solution)

QUINSAIR is a proprietary inhaled formulation of levofloxacin, a fluoroquinolone antibiotic, which is approved in the European Union and Canada for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with CF. Administration of QUINSAIR with the high efficiency Zirela® Nebulizer System (PARI Pharma GmbH) allows for the delivery of high concentrations of active drug directly to the site of infection in approximately five minutes. QUINSAIR is contraindicated in patients with hypersensitivity to levofloxacin, a history of tendon disorders related to fluoroquinolones, or epilepsy and also patients who may be pregnant or breast feeding. QUINSAIR's safety was evaluated in two double-blind, placebo-controlled studies and an active comparator study in which the most frequently reported adverse reactions were cough/productive cough, dysgeusia and fatigue/asthenia.

About Cystic Fibrosis

Cystic fibrosis (CF) is a rare, life-threatening genetic disease affecting approximately 75,000...


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