This follows US FDA approval in August 2018 for its Sydney manufacturing facility to produce and supply Aridol to the US through its exclusive distribution partner Methapharm Inc.
Methapharm has extensive experience in the sales channels and specialist centres that conduct lung function testing.
Pharmaxis’s CEO Gary Phillips said, “Aridol was approved by the FDA in 2011 to identify bronchial hyperresponsiveness and commercialised by Pharmaxis in the US until its withdrawal from the market in 2013 as part of a corporate restructuring when we closed the facility used to manufacture Aridol for the US.
“Two years ago Pharmaxis partnered with Methapharm to re‐enter the US market and commenced the validation work required to have our remaining manufacturing facility approved by the FDA for Aridol.
“Both Methapharm and Pharmaxis believe there remains a strong need in the US for objective tests to aid physicians in diagnosing asthma. It’s good to be back.”
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Pharmaxis has a portfolio of drugs ranging from the pre-clinical phase through to the clinical phase and finally drugs in the commercial phase such as Aridol® and Bronchitol®.