For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
Pharmaceutical company Pharmaxis (ASX:PXS) is pleased to announce that it has appointed PharmaSwiss SA, a division of Valeant Pharmaceuticals International, Inc, as distributor for Bronchitol® in Poland and ten other Eastern European countries.
Headquartered in Switzerland, PharmaSwiss operates in 17 Central and Eastern European countries with regional expertise across regulatory affairs, compliance, sales, marketing and distribution.
Pharmaxis CEO Mr Gary Phillips said, “Pharmaxis is moving swiftly in executing plans for the continued commercialisation of Bronchitol. With more than 6,000 cystic fibrosis patients, Poland is a solid market where our European Union approval applies. PharmaSwiss is well equipped to support us with a firm presence in Poland and other Eastern European countries.”Read full media release - pdf
Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had concluded a productive end of review meeting with the US Food and Drug Administration (FDA) which has provided the Company with a clear outline of the clinical trial required to gain approval for Bronchitol® (mannitol) to treat cystic fibrosis (CF) in the United States.
The Type A meeting discussed the remaining clinical work required to show substantial evidence of efficacy in patients with cystic fibrosis. The FDA and Pharmaxis agreed that the clearest and most expeditious regulatory path forward is to conduct a further single pivotal trial in adults aged 18 years and over. It was also agreed that the trial should have a very similar design to the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302). It will be of six months duration with improvement in lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1) as its primary endpoint.Read full media release - pdf
Pharmaxis Meeting FDA to Discuss Bronchitol for Cystic Fibrosis; Business Review Announcement End of May
Pharmaceutical company Pharmaxis (ASX: PXS) announced it will meet this week with representatives of the Food and Drug Administration (FDA) to discuss the key parameters of the clinical trial necessary to secure approval for Bronchitol® (mannitol) for the treatment of cystic fibrosis in the USA.
The Type A meeting with the Division of Pulmonary, Allergy and Rheumatology Products (DPARP) will be attended by members of Pharmaxis’ medical and regulatory teams and will take place in Maryland, USA.
Pharmaxis CEO Mr Gary Phillips said, “This meeting is an opportunity for a structured discussion with the FDA on key points of its evaluation of the Company’s New Drug Application and the pathway for approval of Bronchitol. Pharmaxis is seeking guidance so it can design a clinical trial to meet the FDA’s requirements for substantial evidence of the efficacy of Bronchitol in patients with cystic fibrosis.
“The outcome of the FDA meeting will allow Pharmaxis to finalise a business review and implement a phased restructuring based around the expected delay to US revenue and the approval paths for Bronchitol in cystic fibrosis and bronchiectasis. The results of this review will be announced by the end of May 2013.”
Read full media release - pdf