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Pharmaxis Ltd expects review of Bronchitol NDA to be completed by mid-2020

Pharmaxis Ltd (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) CEO Gary Phillips speaks to Proactive's Andrew Scott after it was announced its US licensee Chiesi Farmaceutici SpA filed a resubmission to the FDA for Bronchitol® .

The move addresses issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 and follows completion by Chiesi Group of a supplemental human factor study in the first quarter of 2020.

If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million (A$15.5 million) milestone payment on the supply of Bronchitol for the US commercial launch and mid to high teen percentage royalties on in-market net sales.

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Price: 0.08 AUD

ASX:PXS
Market: ASX
Market Cap: $31.66 m
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Pharmaxis to progress myelofibrosis drug to Phase II following positive results

Pharmaxis Ltd's (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) Gary Phillips tells Proactive's Andrew Scott they're progressing to a phase II study of its oral anti-fibrotic pan-Lysyl Oxidase (LOX) inhibitor PXS-5505 for treatment of the rare bone cancer, myelofibrosis (MF). The move comes on the back...

on 28/4/20

2 min read