Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) has today received a US$7 million (~A$9.2 million) milestone payment from its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) following the recent approval by the US Food Drug Administration of Bronchitol®(mannitol) for the treatment of cystic fibrosis.
A further US$3 million is payable by Chiesi on shipment by Pharmaxis of commercial launch stock, scheduled for the first quarter of 2021.
Pharmaxis reported cash funds of A$10 million at 30 September 2020 to which it has since added a R&D tax incentive of $5 million in October and this milestone of A$9 million.
On 2 November 2020 it was announced that the FDA had approved Bronchitol, the drug Pharmaxis developed, for the treatment of adult cystic fibrosis patients in the United States.Read full media release - pdf
FDA approval for Bronchitol® marked a big day in the history of Pharmaxis. Watch this interview with CEO Gary Phillips about what it means for the company and the work now being advanced to find a new treatment for a rare cancer: https://t.co/G4TPprw2lw?amp=1
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced details of the clinical development plan for its lead drug pipeline asset being studied for the bone marrow cancer myelofibrosis.
PXS-5505 has already received IND approval and Orphan Drug Designation from the FDA and will proceed to an open label study recruiting up to 42 patients with myelofibrosis in Australia and international sites. PXS-5505 is a pan-LOX inhibitor that seeks to reverse the bone marrow fibrosis that drives morbidity and mortality in the disease.Read full media release - pdf