Pharmaxis (ASX:PXS) has announced that its US partner Chiesi has launched BRONCHITOL (mannitol) in the US.
BRONCHITOL, which was discovered, developed and is manufactured in Australia, is an add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients aged 18 years and older. It is the first dry powder inhaled mucoactive agent providing a compact, portable treatment option for CF patients.
Chiesi also announced that data from Pharmaxis' phase three 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.
Pharmaxis said it has so far received a total of US$10 million in BRONCHITOL milestone payments from Chiesi triggered by FDA approval in October 2020 and the recent first shipment of stock to the US.
Pharmaxis CEO 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.”
BRONCHITOL is approved and PBS-listed for the treatment of adults and children in Australia with CF and is also marketed in Europe, Russia and several other countries.