Bayer’s cipro inhaler to treat cystic fibrosis may get priority review in US

Ciprofloxacin dry powder inhaler to treat cystic fibrosis caused by Pseudomonas aeruginosa has been given Orphan Drug designation in US, announced Bayer Healthcare.

Ciprofloxacin dry powder inhaler is an investigational drug–device combination that combines ciprofloxacin dry powder formulated using Novartis’ proprietary PulmoSphere technology with a delivery inhaler.

First-in-man studies with ciprofloxacin dry powder inhaler in cystic fibrisis patients showed that the drug reached high concentrations in the lung with very low systemic exposure following single and multiple dose administration.

Bayer is now conducting a multinational Phase II study evaluating safety and efficacy in cystic fibrisis patients.

The Orphan Drugs Act provides incentives to sponsors to develop products for rare diseases.  The first sponsor who obtains marketing approval for a designated orphan drug or biological product is granted US market exclusivity for a seven-year period, under legislation passed by the U.S. Congress in 1983.

Exclusivity begins on the date that the marketing application is approved by US FDA for the designated orphan drug and applies only to the indication for which the drug has been designated and approved.

“There continue to be significant unmet medical needs for people with cystic fibrosis,” stated Shannon Campbell, vice president and general manager, Oncology and General Medicine, Bayer HealthCare Pharmaceuticals.

Ciprofloxacin dry powder inhaler to treat cystic fibrisis has already been granted a similar designation by the European Medicines Agency.

An additional clinical study of ciprofloxacin dry powder inhaler not related to the orphan drug designation for cystic fibrosis is ongoing.

This study in patients with non-CF bronchiectasis is evaluating the safety and efficacy of ciprofloxacin dry powder inhaler with respect to overall bacterial load and clinical outcomes.

Cystic fibrosis is a life-threatening inherited disease affecting the lungs, pancreas, liver, and intestines.

Approximately 30,000 patients in the US are affected by cystic fibrisis. The median age of survival for patients in the US was 37.4 years in 2008, according to data compiled by the Cystic Fibrosis Foundation.

The major consequences of the disease are pancreatic insufficiency and reduced lung function. Lung disease accounts for about 90 percent of the mortality associated with cystic fibrisis.
Patients with cystic fibrosis have dehydrated, thickened respiratory secretions that are difficult to clear and provide an attractive environment for bacteria, thus increasing the risk of infection and inflammation.

Pulmonary infections in CF patients are a chronic problem and represent the leading cause of exacerbations and mortality.

P. aeruginosa is the leading pathogen in CF patients. The thick mucus in the lungs is ideally suited to bacteria, and individuals with CF are colonized and infected by bacteria from an early age; about 20 percent of children under 1 year of age and 80 percent of adult patients with CF have P. aeruginosa present in their sputum.

Chronic infection with P. aeruginosa is associated with an accelerated decline in pulmonary function, more frequent exacerbations, and increased mortality in patients with cystic fibrosis.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG.

Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions.

In the U.S., Bayer HealthCare Pharmaceuticals comprises Women’s Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology and Oncology business units.