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Pharmaxis receives FDA approval to produce Aridol for US market

Published: 12:20 15 Aug 2018 AEST

key on keyboard that says 'FDA APPROVAL'
Earlier this month, the company secured $24 million in funds through a placement

Pharmaxis Ltd (ASX:PXS) has received good news for its respiratory business after gaining approval from the US Food and Drug Administration (FDA) for its Sydney manufacturing facility to produce Aridol for the US market.

Aridol is a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation.

Commercial sales of Aridol in the US will commence in the coming December quarter via Pharmaxis’ exclusive distributor in North America, Methapharm Inc.

Notably, Methapharm are experts in the specialist respiratory diagnostic market.

READ: Pharmaxis secures $24 million at premium to support partnering negotiations

Pharmaxis’ CEO Gary Phillips said: “Aridol has proven to be a valuable diagnostic aid in respiratory function laboratories in many global markets. 

“I am delighted that the FDA, having inspected our Sydney manufacturing facility, has given approval to recommence supply of the product to the US market.

“We are also very pleased to have Methapharm, who have many years of experience in the US, to commercialise the product.

“This partnership will bring the benefits of this indirect bronchial challenge test kit to US patients with respiratory symptoms and add a valuable income stream to this business segment of Pharmaxis.”

US market an opportunity to double Aridol sales

Global sales of Aridol excluding the US are currently $2 million per annum and Pharmaxis believes that the US market offers an opportunity to at least double that revenue. 

The company’s Sydney facility in Sydney manufactures Aridol for Europe, Australia and South Korea as well as Bronchitol for Europe, Australia and Russia.

Bronchitol is an inhaled dry powder for the treatment of cystic fibrosis.

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