Pharmaxis (ASX:PXS) has triggered a US$3 million milestone payment after exporting the first shipment of its locally developed and manufactured drug BRONCHITOL (mannitol) to the US.
BRONCHITOL is a cystic fibrosis (CF) treatment that was approved by the US FDA in October last year. The approval triggered a US$7 million milestone payment from its exclusive US distributor Chiesi.
BRONCHITOL is manufactured at the company's purpose-built factory in the Sydney suburb of Frenchs Forest. It has now despatched the first shipment of the therapy to Atlanta.
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. 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.”
Pharmaxis said it expects sales in the US to contribute strongly to the product’s global revenue and profit growth. It said it plans for the mannitol respiratory business to be cash flow positive from the financial year 2021.
BRONCHITOL is approved in Australia and reimbursed through the PBS for the treatment of adults and children in Australia with CF. It is also marketed in Europe, Russia and several other countries.