Forest Laboratories' Colobreathe dry powder inhaler receives EMA approval

Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that it has been granted European Medicines Agency (EMA) approval to market Colobreathe dry powder colistimethate sodium for inhalation for treating cystic fibrosis patients aged 6 years and older with chronic lung infection caused by P. aeruginosa. The pivotal clinical study of Colobreathe demonstrated the benefits and its ability to prevent deterioration of respiratory function in Cystic Fibrosis patients.

The pivotal study which was submitted to EMA for authorization was an open-label active comparator study comparing the efficacy of Colobreathe to TOBI® (tobramycin nebuliser 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.

Forest Laboratories Europe has marketed a nebulised form of colistimethate sodium, an antibiotic used to treat the principal bacterial infections in cystic fibrosis patients, under the brand name Colomycin®, in the UK and Ireland for many years. In 2011 Forest Laboratories acquired all rights held by Gruenenthal to colistimethate sodium in several European countries and also reacquired rights to Colobreathe previously licensed from Forest. The acquisition was a strategic fit for Forest as a first step to expand its commercial capabilities in Austria, Belgium, Germany, The Netherlands, Russia and Switzerland, in addition to its existing presence in the UK and Ireland.

Raymond Stafford, Chief Executive Officer of Forest Laboratories Europe, said "Colistimethate sodium has been available from Forest for many years in a standard nebulised presentation in the UK and Ireland. Instead of requiring up to thirty minutes of inhalation from a nebuliser Colobreathe is an advance to aid patient compliance and convenience utilizing the Turbospin^® inhaler which is small enough to be easily carried and is easy to administer the necessary dose in less than a minute. 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."