Bayer Schering Pharma granted orphan drug status for CF treatment

Bayer Schering Pharma has received orphan drug designation from the Food and Drug Administration (FDA) for a treatment for chronic pulmonary infections related to cystic fibrosis (CF).

The ciprofloxacin dry powder inhaler (DPI) treatment, which is formulated using Novartis’ PulmoSphere technology and administered using an inhaler, was granted this classification following positive clinical trial results.

This follows a similar decision from the European Medicines Agency and guarantees the company exclusive rights to market its treatment for the rare condition.

Dr Jean-Philippe Milon, head of the general medicine global business unit at Bayer Schering Pharma, described the news as a positive step for sufferers of the disease.

He said: “With ciprofloxacin DPI, we are investigating a promising and convenient treatment option for CF patients worldwide.”

Earlier this week, the company commenced a phase III clinical trial of its contrast agent Gadovist for application in magnetic resonance imaging of breast cancer patients.