Pharmaxis Announces Resubmission of Bronchitol® NDA in USA
Release Date: 20/12/2018 10:01am
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.
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