FDA approval for Pharmaxis manufacturing facility

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Sydney-based Pharmaxis (ASX:PXS) has received approval from the US FDA for its manufacturing facility to produce the asthma diagnostic product Aridol for the US market.

The company said the approval follows a recent onsite inspection by the FDA of its manufacturing facility in Sydney. It manufactures Aridol for Europe, Australia, and South Korea as well as Bronchitol for Europe, Australia and Russia. 

The Pharmaxis factory in Sydney is a purpose-built facility that manufactures, packages and exports the company's products.

It is equipped with one of the largest pharmaceutical grade spray driers in the world, which is capable of producing highly refined inhalable powder for the diagnosis and treatment of respiratory conditions.

Pharmaxis said it plans to relaunch Aridol in the US market in late 2018 through its exclusive distribution partner Methapharm.

Annual global sales of Aridol are currently $2 million per annum and Pharmaxis said it believes the addition of the US market could at least double that revenue.  

Aridol was approved by the FDA in 2011 to identify bronchial hyperresponsiveness. It was commercialised by Pharmaxis in the US until its withdrawal from the market in 2013 as part of a corporate restructuring.

The company said recent US market research suggests there remains a "strong need" for objective tests to aid physicians in diagnosing asthma and that Aridol’s mechanism of action and ease of use will be highly valued by respiratory specialists.

According to Pharmaxis CEO Gary Phillips, “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.”

Craig Baxter, CEO of Methapharm said, “We are very excited to add Aridol (mannitol inhalation powder) to our growing portfolio. We see the commercialisation of Aridol as an integral part of our continued efforts to demonstrate the value of objective testing for patients suspected of having asthma or other respiratory disorders. Through our planned investments in education and training, and by combining Aridol with our existing product offering, we believe we will be able to ensure maximum usage and market penetration.”