Forest Labs get EU appro for Colobreathe

US drugmaker Forest Laboratories (NYSE: FRX)  said on Friday that the European Medicines Agency has approved its Colobreathe dry powder colistimethate sodium for inhalation for treating cystic fibrosis patients aged six years and older with chronic lung infection caused by P. aeruginosa.

Raymond Stafford, chief executive of Forest Laboratories Europe, said: “Colobreathe was fully developed in-house by Forest Europe, and its approval is a significant milestone as Forest expands our European footprint. Forest will be establishing affiliates in several additional European countries and some territories outside the EU to support the launch and commercialization of Colobreathe, as well as additional products in the Forest pipeline. We plan to introduce Colobreathe first in Germany by mid 2012 closely followed by other European countries and the UK in September.”

The pivotal clinical study of Colobreathe demonstrated the benefits and its ability to prevent
deterioration of respiratory function in Cystic Fibrosis patients. This study, which was submitted to EMA for authorization, was an open-label active comparator study comparing the efficacy of Colobreathe to TOBI (tobramycin nebulizer solution for inhalation). This study also demonstrated better patient acceptability of Colobreathe. Importantly, data from the study of Colobreathe showed that overall the product was well tolerated and there was no emergence of antibacterial resistance, according to Forest.