NOVATO, Calif., April 11, 2016 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq: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 people worldwide. CF is caused by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Defective or missing CFTR protein causes poor flow of salt and water into or out of cells in several organs, including the lungs. This leads to the buildup of abnormally thick secretions that can cause chronic lung infections and progressive lung damage that in many patients eventually leads to death.
About Raptor Pharmaceutical
Raptor Pharmaceutical Corp. is a global biopharmaceutical company focused on the development and commercialization of transformative therapeutics for rare, debilitating and often fatal diseases. Raptor is leading the global commercialization of two products for orphan diseases, including PROCYSBI®, for the management of nephropathic cystinosis in adults and children ages 2 years and older, and QUINSAIRTM, an inhaled fluoroquinolone antibiotic for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF). Raptor’s R&D pipeline includes RP103, known commercially as PROCYSBI, for Huntington's disease and mitochondrial disorders, including Leigh syndrome. Raptor holds several orphan drug designations, including orphan drug exclusivity for nephropathic cystinosis in the U.S. and EU. The pipeline also includes MP-376, known commercially as QUINSAIR, which has Qualified Infectious Disease Product (QIDP) designation for three distinct indications: for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa, in patients with CF and in patients with non-cystic fibrosis bronchiectasis (BE), and in patients with nontuberculous mycobacteria (NTM). Raptor holds orphan drug designation in the U.S. for MP-376 for the treatment of CF, which, when added to the 5 years of exclusivity associated with QIDP designation, would confer 12 years of regulatory exclusivity upon FDA approval.
For additional information, please visit www.raptorpharma.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are indicated by words or phrases such as "believes," "expects," "anticipates," "estimates," "plans," "continuing," "ongoing," "projected" and similar words or phrases and relate to future events, including statements regarding: PROCYSBI as a treatment option for patients with nephropathic cystinosis, Huntington's Disease and mitochondrial disorders, including Leigh Syndrome, QUINSAIR as a treatment option, including timing of its launch, for patients with chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF) in Europe and Canada, Raptor's plans to further develop MP-376 in cystic fibrosis, bronchiectasis not associated with cystic fibrosis and potentially also nontuberculous mycobacteria and the timing and outcome of those development programs and any discussions with regulatory authorities and Raptor's other development programs. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the company's actual results to be materially different from these forward-looking statements. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Factors which may contribute to differences in actual results include, among others: Raptor's ability to market and sell QUINSAIR; continued and increased market acceptance and sales of PROCYSBI in the U.S. and other territories; Raptor's ability to expand the use of RP103 and MP-376 and to receive regulatory approval for other indications; Raptor's reliance on single active pharmaceutical ingredient suppliers for PROCYSBI and QUINSAIR and other third parties in connection with drug product development; compliance with healthcare regulations, ongoing regulatory requirements and potential penalties; any serious adverse side effects associated with PROCYSBI, QUINSAIR or any other future products; any product liability claims; third-party payor coverage, reimbursement and pricing for PROCYSBI, QUINSAIR and future products; enacted and future healthcare legislation; Raptor's ability to obtain and maintain orphan drug or other regulatory exclusivity for PROCYSBI, QUINSAIR or any other future products; the integration of European operations with U.S. operations; relationships with key scientific and medical collaborators; intellectual property protection and claims and continued license rights; and Raptor's ability to fund its operations and make required payments on its debt. Certain of these risks, uncertainties and other factors are described in greater detail in the company's filings from time to time with the Securities and Exchange Commission (SEC), which Raptor strongly urges you to read and consider, including: Raptor's annual report on Form 10-K for the twelve months ended December 31, 2015 filed with the SEC on February 26, 2016 and Raptor's other periodic reports filed with SEC, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor's reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements except as may be required by law.