Australian pharmaceutical research company Pharmaxis Ltd (ASX:PXS) exported the first shipment of its locally developed and manufactured cystic fibrosis (CF) drug Bronchitol™ (mannitol) to the USA, following US Food and Drug Administration (FDA) approval, the company announced today.
Pharmaxis secured FDA approval for the CF treatment on 30 October 2020.
The first shipment to Atlanta, Georgia follows a ramp-up in production of Bronchitol™, which has been manufactured and prepared for export by Pharmaxis employees at the company’s purpose-built factory in Frenchs Forest, Sydney.
Pharmaxis also revealed that it will receive an additional US$3 million (~A$4 million) milestone payment, following receipt of an initial payment of US$7 million (~A$10 million) from exclusive US distributor Chiesi.
Commenting on the company milestone, 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.
According to Phillips, the production of drugs meant to be delivered to the lungs is one the most challenging aspects of medicine manufacturing.
He added that Pharmaxis’ TGA and FDA-approved facility is well-equipped with technology to create a powder suitable for delivery via a hand-held inhaler.
Each Bronchitol™ capsule is filled with the powder, and then packaged with the information required for use by CF patients who should take the drug twice per day.
CF is a hereditary disease that causes persistent lung infections and progressive damage to the digestive system and other organs in the body.
Pharmaxis expects the CF treatment’s arrival in the US market will drive the product’s global sales and profit growth further into positive territory for FY 2021.
“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.”