Pharmaxis names Brazil distributor for Bronchitol

Pharmaxis (ASX:PXS) has arranged to expand the reach of cystic fibrosis treatment Bronchitol, signing on an exclusive distributor in Brazil.

Pharmaxis has appointed Brazilian distributor United Medical as its exclusive distribution partner and sales representative in the major market.

United Medical plans to file for marketing approval with Brazilian regulator ANVISA, based on Bronchitol’s successful Australian application.

The regulatory process is expected to take around 18 months. Under the agreement, Pharmaxis will be entitled to milestone payments ahead of the approval.

Pharmaxis CEO Gary Phillips said the deal “is an important step forward in our plans to commercialise Bronchitol wherever there are significant markets. Brazil has an estimated 3500 cystic fibrosis patients with 32 specialist treatment centres and a well-funded reimbursement scheme providing access to new medications.”

Bronchitol is a proprietary formulation of Mannitol, administered through the lungs as a dry powder. It is designed to hydrate the lungs and assist with mucus clearance.

The product is approved for cystic fibrosis and listed on the PBS in Australia, and also has approval in the EU. Pharmaxis launched the product in Europe in June last year.

Pharmaxis is also seeking approval for Bronchitol as a treatment for bronchiectasis, and last month completed a multinational phase III trial as part of this process.

Pharmaxis shares were trading 1.56% higher at $0.325 as of around 12.30 pm on Wednesday.