FDA Grants Orphan Drug Designation for Bayer's Investigational Ciprofloxacin DPI (Dry Powder for Inhalation) for Treatment of Non-Cystic Fibrosis Bronchiectasis

WHIPPANY, N.J., April 22, 2014 /PRNewswire/ -- Bayer HealthCare today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB). Patients with NCFB suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway and lung parenchyma damage.

The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S, or that affect more than 200,000 but are not expected to recover the costs of developing and marketing a treatment drug.

About Ciprofloxacin DPI
Ciprofloxacin DPI is in development by Bayer HealthCare as chronic intermittent therapy for reducing the frequency of acute exacerbations in NCFB patients with bacterial respiratory pathogens. It comprises ciprofloxacin, a fluoroquinolone antibiotic, formulated into dry powder for inhalation using Novartis' PulmoSphere™ technology and is administered with the T-326 Dry Powder inhaler.  Ciprofloxacin DPI therapy in NCFB is currently being investigated in a global Phase III clinical trial program (RESPIRE; NCT01764841).   

About Non-Cystic Fibrosis Bronchiectasis
NCFB is a chronic respiratory disease of which up to 50 to 80 percent of cases may be idiopathic.¹  A vicious cycle of recurrent microbial infections and persistent inflammation leads to further damage of airway walls and predisposes the lung to new infections.^2,3  Bacterial colonization of the airways, most commonly with Haemophilus influenzae and Pseudomonas aeruginosa, is found in more than 60 percent of adult patients with stable bronchiectatic disease.²  In particular, presence of Pseudomonas aeruginosa has been associated with accelerated decline in lung function.¹  

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. O'Donnell AE, "Bronchiectasis," Chest, no. 134, pp. 815-823, 2008.
2. King PT, "The pathophysiology of bronchiectasis," International Journal of COPD, no. 4, pp. 411-419, 2009.
3. Angrill J, et al., "Bacterial colonization in patients with bronchiectasis: microbiological pattern and risk factors," Thorax, no. 57, pp. 15-19, 2002.

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SOURCE Bayer HealthCare