May 13, 2020: ” Pharmaceutical research company Pharmaxis Ltd announced its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) has received acknowledgement of receipt of the Bronchitol NDA resubmission from the US Food and Drug Administration (FDA).
The receipt of this communication from the FDA indicates that the submission responds to all issues raised in the complete response letter received in June 2019.
However, the FDA have classified the resubmission as Class 2 which changes the FDA review period from an expected two months to six months and sets a Goal Action Date of 1 November 2020.
Pharmaxis CEO Gary Phillips said, “While I am pleased that the FDA has confirmed Chiesi’s submission to be complete, I am disappointed the FDA has exercised its discretion to set a six month review timetable.
The US$10 million launch milestone payable by Chiesi subsequent to an approval of Bronchitol by the FDA therefore moves from the fourth quarter of 2020 to the first quarter of 2021.” Chiesi Group is responsible for the regulatory approval and commercialisation of Bronchitol in the United States.
If Bronchitol is approved by the FDA, Pharmaxis will receive the US$10 million milestone payment on the supply of Bronchitol for the US commercial launch and additional mid to high teen percentage royalties on in‐market net sales.
Pharmaxis will manufacture and be the exclusive supplier of Bronchitol for the US market.
Bronchitol is approved and marketed in Europe, Russia, Australia and several other countries.”
http://www.pharmaxis.com.au/assets/Documents/pdf/02020/ASX/2020-05-13-Bronchitol-FDA-Goal-Date.pdf
