Pharmaxis Ltd (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) has exported the first shipment of its locally developed and manufactured drug Bronchitol® (mannitol) to the US after the cystic fibrosis (CF) treatment was approved by the US Food and Drug Administration (FDA) in October 2020.
Following receipt of an initial payment of US$7 million (approximately A$10 million) from its exclusive US distributor Chiesi, Pharmaxis will now receive a further US$3 million (~A$4 million) milestone payment.
The pharmaceutical research company 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 financial year 2021.
“Proud and rare achievement”
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.
“Production of drugs for delivery to the lungs is one of the most difficult processes undertaken in medicine manufacturing.”
Shares were as much as 11% higher today to A$0.097 on volume of more than 2.6 million.
Equipped with technology
Phillips added: “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.
“I’d like to thank our production staff for their unwavering dedication and we look forward to servicing the US market with a new treatment option in CF.”
Approved facility in Frenchs Forest
After ramping up production at its purpose-built factory in the Sydney suburb of Frenchs Forest, Pharmaxis dispatched the first shipment of Bronchitol to Atlanta, Georgia.
The drug was manufactured and prepared for export by Pharmaxis employees at the company’s high tech Therapeutic Goods Administration (TGA) and FDA approved facility in Sydney.
CF, a debilitating genetic disease causes progressive damage to the lungs and other organs.
Bronchitol is approved and Pharmaceutical Benefits Scheme (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 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.