Forest Laboratories ($FRX) says it will use Germany to launch the European Union rollout of Colobreathe, its new dry powder inhalation treatment for cystic fibrosis-related lung infections, by midyear, with several other member countries to follow in rapid succession a few months later.
European regulators recently signed off on the treatment, which will help affected patients ages 6 and older with bacterial lung infections related to their condition. So cue the marketing team, and commercialization plans are under way.
The approval gives another drug delivery option for colistimethate sodium, an antibiotic it has previously marketed in the U.K. and Ireland for nebulizers, and reaches patients' lungs after about 30 minutes of treatment. Colobreathe, by contrast, is a capsule with about 125 mg of the antibiotic that's deployed twice daily through the company's Turbospin inhaler, a portable device that lets a patient breathe a dry powder version straight into the lung. Each dose takes less than 60 seconds, according to the company.
Forest said it bought or reacquired the broader European rights to the treatment from Grünenthal, which had marketed it in other countries. According to the company, about 35,000 people in the European Union and 70,000 globally suffer from cystic fibrosis, a rare genetic disease that can lead, in part, to chronic lung infections and lung function decline.
Raymond Stafford, CEO of Forest Laboratories Europe, which developed the new treatment/delivery option, said in a statement that the company plans to use Colobreathe to fuel a broader EU expansion.
Forest, meanwhile, just earned the backing of an FDA panel for an experimental COPD inhaled drug called aclidinium. However, the panel expressed worries about cardiovascular side effects, with some members of the panel urging regulators to require post-marketing studies for the compound.
- here's the release