Raptor Pharmaceuticals Corp. announces first European launch for Quinsair®

Raptor Pharmaceuticals Corp announced that Quinsair (levofloxacin nebulizer solution) is now available in Germany and Denmark.

Quinsair is the first inhaled fluoroquinolone approved in the European Union for the management of chronic pulmonary infections due to P. aeruginosa in adults with cystic fibrosis (CF).^1,2 The product is administered twice-daily, stored at room temperature and has a short administration time.

“Raptor is delighted to offer a new, first-in-class inhaled antibiotic treatment option for adults living with CF who have chronic pulmonary infections due to Pseudomonas aeruginosa,” said Françoise de Craecker, Senior Vice President and General Manager EMEA, Raptor Pharmaceuticals Europe B.V. “Pseudomonas aeruginosa affects around 80% of adults living with CF who have been tested and is one of the most difficult-to-treat infections.³We believe the availibility of Quinsair will bring new hope to many battling this chronic bacterial lung infection.”

“This is the first inhaled fluoroquinolone available to the cystic fibrosis community,” said Professor Elborn, Professor of Respiratory Medicine and Director of the Adult CF Centre in Belfast City Hospital. “New treatment options are a welcome addition to our armoury in the fight against chronic infections in adult CF patients with Pseudomonas aeruginosa.”

“We are very pleased to welcome a new product for adults with cystic fibrosis,” said Jacquelien Noordhoek, President, CF-Europe. “Chronic P. aeruginosa infections can be extremely severe, life-threatening and are becoming increasingly difficult to treat. Access to a wide range of treatment options is crucial in helping people living with cystic fibrosis.”

Although P. aeruginosa is not the only infection that threatens CF patients, it can be fatal to people with the condition, and it is particularly difficult to treat once colonised into the lung biofilm.⁴ Quinsair targets the infection by delivering high concentrations of the active drug directly to the airway via the Zirela^® Nebulizer System (PARI Pharma GmbH).

CF affects around 35,000 people in Europe.⁴ About 7,000 people in Germany⁴ and about 500 people in Denmark⁶ have CF, of which just over half are adults.⁷

References

1. European Medicines Agency. Summary of product characteristics: QUINSAIR. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002789/WC500187845.pdf. Date accessed: April 2016.
2. European Medicines Agency (2014). Quinsair assessment report. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002789/WC500187847.pdf. Date accessed: April 2016.
3. Pressler T. Chronic Pseudomonas aeruginosa infection definition: EuroCareCF working group report. J Cyst Fibr. 2011;10:S75-S78.
4. Høiby N (2011). Recent advances in the treatment of Pseudomonas aeruginosa infections in cystic fibrosis. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3087692/. Date accessed: April 2016.
5. Colombo C (2011). The implementation of standards of care in Europe: State of the art. Available at: https://www.ecfs.eu/files/webfm/webfiles/File/documents/JCF%20Articles/JCF10_Sup2_S7_S15.pdf. Date accessed: April 2016.
6. European Cystic Fibrosis Society (2010). ECFS patient registry annual data report: 2008-2009 data. Available at: https://www.ecfs.eu/files/webfm/webfiles/File/ecfs_registry/ECFSPR_Report0809_v32012.pdf. Date accessed: April 2016.
7. Armstead J (2014). Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis. Available at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0098502#pone.0098502-Viviani1. Date accessed: April 2016.
8. Butler CA (2014). New insights into gene-specific management in cystic fibrosis from the 2012 European Cystic Fibrosis Conference. Available at: http://www.tandfonline.com/doi/full/10.1586/ers.12.52. Date accessed: April 2016.