Pharmaxis Ltd’s (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) exclusive US distributor, Chiesi USA Inc, has launched Bronchitol® (mannitol), an add‐on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients aged 18 years and older in the US.
Bronchitol, developed by Pharmaxis, is the first dry powder inhaled mucoactive agent providing a compact, portable treatment option for CF patients.
Cash flow positive from FY2021
Pharmaxis chief executive officer Gary Phillips said: “We expect Bronchitol sales in the US to contribute strongly to the product’s global sales and profit growth, making the Pharmaxis mannitol respiratory business cash flow positive from FY 2021.”
The company has so far received a total of US$10 million in Bronchitol milestone payments from Chiesi, triggered by the US Food and Drugs Administration (FDA) approval in October 2020 and the recent first shipment of stock to the US.
Phase 3 trial published
Chiesi also reveals that data from the Pharmaxis Phase 3 global clinical trial (CF303) evaluating the efficacy and safety of Bronchitol in adults with CF has been published online in the Journal of Cystic Fibrosis.
Bronchitol
Bronchitol is manufactured and exported from the Pharmaxis manufacturing facility in Sydney. The product is marketed in Europe, Russia and several other countries and is PBS listed for the treatment of Australian adults and children.
CF is a debilitating genetic disease that causes progressive damage to the lungs and other organs.
Chiesi
Chiesi is responsible for the commercialisation of Bronchitol in the US.
Bronchitol joins Pharmaxis' first commercial product, Aridol®, in being FDA‐approved.
Aridol is a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation.