Pharmaceutical research company Pharmaxis has received FDA approval to produce the asthma product Aridol for the US market.
The approval follows a recent onsite FDA inspection of the Pharmaxis manufacturing facility in Sydney, where the company currently manufactures Aridol for Europe, Australia and South Korea, as well as Bronchitol for Europe, Australia and Russia.
Pharmaxis will relaunch Aridol into the US market later in 2018 via its exclusive distribution partner Methapharm, which has extensive experience in the sales channels and specialist centres that conduct respiratory testing. Global sales of Aridol (ex-US) are currently A$2 million a year, and Pharmaxis believes that the addition of the US market offers an opportunity to at least double that revenue.
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.”
Methapharm CEO Craig Baxter 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 maximal usage and market penetration.”
First approved by the Australian TGA in 2012, the Pharmaxis factory in Sydney is described as a unique purpose-built facility that manufactures, packages and exports Pharmaxis 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.