Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today 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.Read full media release - pdf
Ticker Today interview with Pharmaxis CEO Gary Phillips on 12 May 2020.
Watch the interview here.
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.
Watch the interview here.
Gary Phillips, CEO of Australian biopharma company, Pharmaxis Ltd, discusses ensuring continuity of supply of its products throughout the crisis, the timeframe for trials of its unique anti-fibrotic treatment for a rare bone cancer, broader impacts for biopharma research and trials, the opportunity for the global industry and the potential for PXS respiratory products in the clinical aftermath of COVID -19.
Recorded 29 April 2020.
Listen to the podcast here.
Chiesi Files Resubmission to Address FDA Bronchitol (Mannitol) Inhalation Powder Complete Response Letter
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced its US licensee Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group) has filed a resubmission that addresses the issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 to the Bronchitol® New Drug Application (NDA). This resubmission follows Chiesi Group’s successful completion of a supplemental human factor study in Q1 2020 which was the most significant body of additional data required by the FDA. The proposed indication for Bronchitol is management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. The FDA review of the Bronchitol NDA is expected to be completed in mid-2020.Read full media release - pdf