Pharmaxis has announced that Chiesi Farmaceutici will take over marketing and distribution of Bronchitol mannitol DPI in Italy. Bronchitol has been approved in the EU for the treatment of cystic fibrosis in patients 18 years old and older since 2012.
In 2015, Pharmaxis and Chiesi announced an agreement for distribution rights to Bronchitol in the UK, Ireland, and Germany. Chiesi continues to market Bronchitol in those countries, with Pharmaxis continuing to manufacture the product.
According to Pharmaxis, the two companies are close to extending their supply agreement for the inhaler to 2024.
Pharmaxis CEO Gary Phillips commented, “We are extremely pleased that Chiesi has sought to extend the number of European countries in which they distribute Bronchitol. Chiesi’s local market knowledge and experience will be valuable in the commercial launch of the product in Italy. We have been pleased with their management of the product and, of course, look forward to also working with them in the United States, where an exclusive distribution agreement is already in place.”
In 2013, Pharmaxis received a complete response letter from the FDA in regards to its NDA for Bronchitol. The company said that it is expecting top line results from a recently completed Phase 3 trial designed to meet the FDA’s requirements by the end of this quarter.
Read the Pharmaxis press release.