Chiesi USA Announces Commercial Launch of Pharmaxis’ Cystic Fibrosis Drug Bronchitol

• Total of US$10 million in milestones in relation to US approval now received
• Bronchitol Phase 3 Study data published in Cystic Fibrosis Journal

Pharmaxis Ltd (ASX: PXS) today announced that Chiesi USA, Inc. (Chiesi), 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 United States. Bronchitol, developed by Pharmaxis, is the first dry powder inhaled mucoactive agent providing a compact, portable treatment option for CF patients.

Additionally, Chiesi has announced 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.

Pharmaxis 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 USA.

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.”

CF is a debilitating genetic disease that causes progressive damage to the lungs and other organs. 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.

Chiesi is responsible for the commercialisation of Bronchitol in the United States. 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.