Aussie Pharmaxis exports cystic fibrosis drug to the US

Pharma News: Australian pharma company Pharmaxis has exported the first shipment of its locally developed and manufactured drug Bronchitol (mannitol) to the USA.

The cystic fibrosis (CF) treatment was approved by the US Food and Drug Administration (FDA) on 30 October 2020. Following receipt of an initial payment of US$7 million (~A$10 million) from its exclusive US distributor Chiesi, Pharmaxis will now receive a further US$3 million (~A$4 million) milestone payment.

Pharmaxis CEO Gary Phillips said “This represents a proud and very rare achievement for a home-grown pharmaceutical research company. Not only did the team at Pharmaxis design, lead and complete the three large scale international clinical trials which established Bronchitol as a safe and effective medication for CF patients, we have now manufactured the drug to be used by adult CF patients in the USA.”

After ramping up production at its purpose-build factory in the Sydney suburb of Frenchs Forest, Pharmaxis has now despatched the first shipment of Bronchitol to Atlanta, Georgia. The drug has been manufactured and prepared for export by Pharmaxis employees at the company’s high tech TGA and FDA approved facility in French Forest.

You may also like FMT helps patients with advanced melanoma respond to MSD and BMS’ immunotherapies

“Production of drugs for delivery to the lungs is one of the most difficult processes undertaken in medicine manufacturing.  Our factory is equipped with the technology to engineer a powder with precise control of the particle size, suitable for delivery via a hand-held inhaler. The powder is put into capsules, and then packaged with all the information required for use by CF patients who will take the drug twice a day,” added Mr Phillips.

Pharmaxis expects 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, a debilitating genetic disease 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 Group, will be 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.