Raptor Pharmaceutical Presents Results from Meta-Analysis Demonstrating Efficacy of QUINSAIR™ Comparable to Other Approved, Inhaled Antibiotics in Cystic Fibrosis Patients
NOVATO, Calif., Sept. 07, 2016 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq: RPTP), a biopharmaceutical company developing and commercializing transformative treatments for rare diseases, today presented results from a network meta-analysis comparing inhaled antibiotics for cystic fibrosis (CF) patients with lung infections involving Pseudomonas aeruginosa. The study showed that QUINSAIRTM, a levofloxacin inhalation solution, had efficacy comparable to three other inhalable antibiotics also approved for use in Europe. These data were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.
"Chronic P. aeruginosa lung infection is the primary cause of progressive lung function decline in patients with CF, and long-term maintenance therapy with inhaled antibiotics is recommended to suppress infection, reduce acute pulmonary exacerbations and preserve lung function," said Stuart Elborn, M.D., Professor of Respiratory Medicine in Queen's University and Director of the Adult CF Centre at Belfast City Hospital. "As patients with CF with chronic P. aeruginosa infections frequently require changes in treatment, the availability of levofloxacin provides a useful option to preserve respiratory function over a longer period of time."
Utilizing a systematic literature search, the network meta-analyses leveraged data from all randomized clinical trials of inhaled antibiotics in CF patients with at least 4 or 24 weeks of follow-up, and compared the effect of inhaled antibiotics tobramycin, colistimethate sodium, aztreonam and levofloxacin against P. aeruginosa infections. Of the 685 articles identified, 7 and 9 unique studies were included in the 4 weeks and 24 weeks analysis, respectively.
Aztreonam, dosed at 75 mg three times daily, was predicted to result in the greatest numerical increase in forced expiratory volume in 1 second (FEV1%) at 4 weeks, while levofloxacin inhalation solution was predicted to be numerically greater than colistimethate sodium, tobramycin inhaled solution and tobramycin inhaled powder. The analyses for many of the outcomes did not provide evidence to indicate that the other treatments were more effective than levofloxacin. At 24 weeks, levofloxacin inhalation solution was associated with the lowest risk of hospitalization with a 96.5% of probability to be the best treatment. P. aeruginosa sputum density scores, additional antipseudomonal antibiotics use, and study withdrawal rates were comparable among all inhaled antibiotics at all times.
"This network meta-analysis suggests that inhaled levofloxacin provides a useful addition to our armory in the fight against this common and difficult to treat infection," said Krishna R. Polu, M.D., Chief Medical Officer of Raptor. "Given the chronicity and reduction in survival caused by P. aeruginosa infection in CF, the availability of inhaled levofloxacin is an important option for clinicians to maintain lung function in CF patients and an important step in tackling the unmet need in the CF community."
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: PROCYSBI®, for the management of nephropathic cystinosis in adults and children ages two years and older; and QUINSAIR™, 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. The pipeline also includes MP-376, known commercially as QUINSAIR, which has Qualified Infectious Disease Product (QIDP) designation for three distinct indications: the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with CF; in patients with bronchiectasis (BE); and in patients with nontuberculous mycobacteria (NTM). Raptor holds orphan drug designations in the U.S. and EU for PROCYSBI for nephropathic cystinosis. Raptor also holds orphan drug designation in the U.S. for MP-376 for the treatment of CF, which, when added to the five 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.
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," "intends," "continuing," "ongoing," "projected," "potential" and similar words or phrases and relate to future events, including statements regarding: timing and occurrence of anticipated upcoming milestones, PROCYSBI as a treatment option for patients with nephropathic cystinosis and RP103 as a treatment option for patients with Huntington's disease and mitochondrial disorders, including Leigh syndrome, the availability of orphan drug exclusivity for MP-376 therapy in the U.S., Raptor's plans and timing to develop MP-376 as a treatment for Pseudomonas aeruginosa in CF in the U.S., BE and potentially also NTM in all markets 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: continued and increased market acceptance and sales of PROCYSBI and QUINSAIR; 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, as amended by Amendment No. 1 to Form 10-K filed with the SEC on April 29, 2016, Raptor's quarterly report on Form 10-Q for the quarter ended March 31, 2016 filed with the SEC on May 5, 2016, Raptor's quarterly report on Form 10-Q for the quarter ended June 30, 2016 filed with the SEC on August 4, 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.