Sydney-based Pharmaxis (ASX:PXS) has announced its US licensee Chiesi has received a positive recommendation from a committee advising the US FDA on the use of BRONCHITOL for adult cystic fibrosis patients.
According to the company, after voting separately on the efficacy evidence and the safety profile, nine members of the 16 person committee voted 'yes' to the question. 'Is the benefit‐risk profile adequate to support approval of DPM (dry powder mannitol) for the proposed indication of the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies?'
“The Committee vote is very encouraging, however, we are aware that these recommendations are not binding and Pharmaxis will continue to support Chiesi to work with the FDA to bring Bronchitol to patients in the US. We expect the FDA to make its final decision by mid‐year,” said Pharmaxis CEO Gary Phillips.
BRONCHITOL is an inhaled dry powder for the treatment of cystic fibrosis and has been the subject of three large scale global clinical trials conducted by Pharmaxis. It is approved and marketed in Europe, Russia, Australia and several other countries.
Investors welcomed the announcement, boosting the company's share price by over 10 per cent.
Chiesi is responsible for the regulatory approval and commercialisation of BRONCHITOL in the US.
Pharmaxis will receive a US$10 million milestone payment on the commercial launch of BRONCHITOL in the US following its approval by the FDA. It will also earn 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.