CEO of Australian company Pharmaxis Gary Phillips has told BioPharmaDispatch the company is delighted at having achieved the milestone of securing FDA approval of cystic fibrosis therapy BRONCHITOL (mannitol).
The FDA approved BRONCHITOL as add‐on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older.
Mr Phillips said the approval has triggered a $14 million milestone payment the company will now use to support the ongoing development of its small molecule pipeline, headlined by XS‐5505 for myelofibrosis.
The Pharmaxis boss said the company, which discovered, developed and now manufactures BRONCHITOL locally, is an example of the resilience required in life science development.
He pointed to other companies that spent many years navigating the challenge of pre-clinical and clinical development only to emerge as global biopharmaceutical companies, including Gilead and Galapagos.