Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) is accelerating the timeline on payment of the initial tranche of a US$10 million Bronchitol launch milestone following negotiation with its US licensee Chiesi Farmaceutici S.p.A.
Pharmaxis CEO, Gary Phillips, said US$7 million of the milestone will now be payable by Chiesi upon US approval of Bronchitol by the Food and Drug Administration (FDA) who have advised a Goal Action Date of November 1, 2020. Another US$3 million will remain payable on shipment by Pharmaxis of commercial launch stock in the first quarter of 2021.
The development and commercialisation of Bronchitol reaches a pivotal point on November 1st. Approval by the FDA for Bronchitol would see the mannitol business segment (Bronchitol and Aridol) generate immediate cash and move into profitability,” Mr Phillips said.
“An FDA approval would also provide an opportunity to investigate different ways of structuring the Pharmaxis business and funding our drug development activities. The announcement today is the first to stem from discussions with our partners about how to shape the business post November 1st.”
Bronchitol is an inhaled dry powder for the treatment of cystic fibrosis (CF) and has been the subject of three large scale global clinical trials conducted by Pharmaxis. The product is approved and marketed in Australia, Europe, Russia and several other countries.
Chiesi is the exclusive distributor of Bronchitol in the US as well as eleven countries in the EU, seven of which have been added to Chiesi’s territory in the last 12 months. Pharmaxis and Chiesi are preparing for a US launch of Bronchitol, subject to FDA approval, in the second quarter of 2021.