Bayer plans inhaled Cipro for cystic fibrosis

The aim of the project is to develop a dry powder formulation of ciprofloxacin that could be used to treat infections CF patients.

CF is the most common singe-gene genetic disorder affecting Caucasians, afflicting 2 in every 10,000 people, and is characterised by the production of thick mucus in the lungs that leaves patients vulnerable to respiratory infections. P aeruginosa​ is the most common pathogen causing these infections, and the vast majority of people with CF become chronically colonised with the organism.

While still relatively uncommon, experience with other products has shown that products for treating opportunistic infections in CF can achieve reasonable revenues, as well as providing significant benefits to the patients. For example, US biotechnology company Chiron has an inhaled version of the antibiotic tobramycin, sold under the TOBI brand name, which achieved sales of $159 million (€122m) in the first nine months of 2004, a 30 per cent increase on the same period of 2003.

Cipro is already available in oral and intravenous formulations and brought in revenues of €149 million in the third quarter, well down from its peak as the franchise succumbs to generic competition, particularly in the US, and despite the introduction of a new once-daily formulation as a defensive strategy. The drug has already shown activity in the treatment of P aeruginosa​ infections in CF patients.

Under the terms of the collaboration, Nektar will be responsible for formulation of the dry powder and development of the inhalation system, as well as clinical and commercial manufacturing of the drug formulation and device combination, in return for preclinical funding, royalties and milestone payments. Bayer will take on the clinical development and worldwide commercialisation of the product.