For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
Pharmaceutical research company Pharmaxis (ASX: PXS) today announced the resubmission of the Bronchitol New Drug Application with the United States Food and Drug Administration (FDA) by its licensee Chiesi Group (Chiesi).
The resubmission responds to the matters raised by the FDA in its Complete Response Letter issued in March 2013 and includes the results of the phase 3 clinical trial conducted after consultation with the FDA. The trial reported in June 2017.
Pharmaxis expects the FDA review process to take between six and twelve months to conclude. Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the United States. If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and, mid to high teen percentage royalties on in-market net sales, and Pharmaxis will be the exclusive supplier of Bronchitol for the US market.Read full media release - pdf
Including Senior Research Executives from Boehringer Ingelheim and the Garvan Institute
Pharmaxis hosted an investor research briefing on 20th November 2018 featuring presentations by a Boehringer Ingelheim global project manager and a research leader from the Garvan Institute of Medical Research. The event provided an overview of the Pharmaxis drug discovery pipeline including the anti-inflammatory drug currently being developed by Boehringer Ingelheim, work in collaboration with the Garvan Institute of Medical Research on an anti-fibrotic LOX inhibitor targeting pancreatic cancer and the anti-fibrotic LOXL2 inhibitor program.
Pharmaxis CEO Gary Phillips, Board member Dr Kathleen Metters and Head of Drug Discovery Wolfgang Jarolimek provided commercial and scientific perspectives.
Video recordings of all the presentations can be viewed from this link.