The world’s most lucrative healthcare market is quickly appreciating Aussie pharmaceuticals company Pharmaxis (ASX: PXS) whose cystic fibrosis (CF) treatment Bronchitol is rapidly emerging as the preferred treatment by CF sufferers in the United States.
Researched and manufactured in Australia, Bronchitol gained commercial approval from the US Food and Drug Administration (FDA) in October 2020 and has since been exclusively distributed in the US by Chiesi.
Initially receiving a payment from Chiesi for USD $7 million, sales have been rising over recent months for Bronchitol sales which have resulted in a further USD $3m paid to Pharmaxis.
“This represents a proud and very rare achievement for a home‐ grown pharmaceutical research company,” said Pharmaxis CEO, Gary Phillips.
“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.”
As sales for Bronchitol continue alongside Pharmaxis’ other FDA-approved product – Aridol – the Company expects that their mannitol respiratory business will be cash flow positive from FY21.
Cystic fibrosis, a debilitating genetic disease causes progressive damage to the lungs and other organs.
Following recent discussion with the FDA, Pharmaxis is in the final planning stage of their PXS‐5505 drug which has been granted Orphan Drug Designation and aims to treat Myelofibrosis, a cancer with a poor prognosis and limited therapeutic options.
PXS shares responded well to news of their milestone payment from Chiesi to open at $0.096, a rise of 9% from their previous $0.088 close.