FDA Approves Bronchitol for US Market

2nd Nov 20

Release Date: 02/11/2020 8:30am

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced the United States Food and Drug Administration (FDA) has approved Bronchitol® (mannitol) as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis (CF). The product, developed by Pharmaxis in Australia, has been steered through final stages of FDA approval by US licensee Chiesi Farmaceutici SpA (Chiesi).

A US$7 million milestone is now payable to Pharmaxis by Chiesi with a further US$3 million payable on shipment by Pharmaxis of commercial launch stock scheduled for the first quarter of 2021.

Pharmaxis expects Bronchitol sales in the US market to contribute strongly to the product’s global sales and profit growth from its launch in Q2 2021, making the mannitol business (Bronchitol® and Aridol®) cash flow positive from FY 2021.

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