1. Pharmaxis
2. Home
3. About Us
4. Company History

Company History

Founded in 1998, Pharmaxis was listed on the Australian Stock Exchange in 2003 (symbol PXS). Headquartered in Sydney at its manufacturing facilities, Pharmaxis has grown to become among Australia's largest life sciences companies, with offices in the US, UK and China. In May 2009 Pharmaxis took possession of a new 7,000 square metre factory and headquarters in Frenchs Forest, Sydney, which provides the manufacturing capacity needed for the launch of Bronchitol to overseas markets.

Milestones

2011

• Australian TGA approves Bronchitol for cystic fibrosis
• Aridol launched in USA
• Phase II Trial of ASM8 in subjects with allergic asthma completes enrolment
• The European Committee for Medicinal Products for Human Use recommends approval of Bronchitol for the treatment of cystic fibrosis in patients 18 years and older
  

2010 

• Aridol approved for marketing by the US Food and Drug Administration
• Results announced for second Phase 3 trial (CF302) of Bronchitol in people living with cystic fibrosis
• Positive results achieved for Phase 2 study of ASM8 in patients with asthma
• Phase 1 clinical trial demonstrates PXS25 safe, well tolerated and a pharmacokinetic profile consistent with once per day delivery
• Pharmaxis signs European marketing agreement for Bronchitol
• Pharmaxis completes acquisition of Topigen Pharmaceuticals Inc
• New production facility accredited by the TGA

2009

• Short term Phase 2 cystic fibrosis dosing trial with Bronchitol returns positive results
• Long term Phase 3 bronchiectasis trial demonstrates Bronchitol safe after 12 months treatment
• Marketing application filed for Bronchitol in Australia
• Submission of New Drug Application for Aridol to the FDA
• Commencement of a second Phase 3 trial with Bronchitol in patients with cystic fibrosis
• Pivotal Phase 3 trial in patients with cystic fibrosis demonstrates that Bronchitol is safe and effective
• Completion of purpose built state of the art production facility in Sydney, Australia
• Completion of $54 million capital raising to new and existing investors
• Pharmaxis voluntarily de-lists from Nasdaq
• Second Phase 3 trial in patients with cystic fibrosis passes recruitment target
• Commencement of pivotol Phase 3 bronchiectasis clinical trial
• Submission of application to market Bronchitol for cystic fibrosis in Europe
• FDA Advisory Committee recommends approval of Aridol
• Sustained benefit of Bronchitol in Phase 3 cystic fibrosis trial
• Pharmaxis receives response letter from FDA on Aridol application

2008

• Bronchitol cystic fibrosis dose trial results positive
• 1st global Phase 3 cystic fibrosis trial completes enrollment
• 2nd global Phase 3 cystic fibrosis trial commences enrolment
• Cystic fibrosis trial in children returns positive results with Bronchitol
• 1st Phase 3 bronchiectasis trial reports positive long term safety data
• 1st marketing application filed for Bronchitol with Australian TGA
• Construction begins on new factory and headquarters in Frenchs Forest
• Aridol gains approval in Korea and Switzerland
• Aridol available throughout major European countries
• Aridol for elite athletes accepted by Olympic Committee

2007

• Successful completion of $50 million capital raising and share purchase plan
• EU approval of Aridol — 13 European countries to market
• Phase III Bronchitol trial completes with positive results
• Phase II clinical trial demonstrates role for Aridol in COPD
• European headquarters established in UK

2006

• Aridol approved for sale and marketing in Sweden and Australia
• First European distributors appointed
• U.S. Aridol Phase III trial involving 500 patients concluded successfully

2005

• Manufacturing capacity trippled
• Bronchitol Phase II clinical trial successfully completed
• US FDA grants Bronchitol Orphan Drug status for bronchiectasis and cystic fibrosis
• NASDAQ Global Market listing of Pharmaxis
• Completed global capital raising of $87 million on ASX and NASDAQ — the largest of any Australian pharmaceutical company
• European Medicines Agency grants Bronchitol Orphan Drug status for cystic fibrosis

2004

• Aridol Phase III and Bronchitol Phase II clinical trials successfuly completed
• Capital raising of $19.8 million
• Awarded $6.1 million AusIndustry P3 Grant

2003

• Listed on Australian Securities Exchange, Initial Public Offering raised $25 million
• Manufacturing facility licensed by TGA; production begins
• Awarded $6 million AusIndustry R&D Start Grant to develop new cystic fibrosis treatments

2002

• Completed Series B private funding of $9.6m
• Frenchs Forest facility established

2001

• Pharmaxis licenses patents for respiratory products from technology developed by Royal Prince Alfred Hospital, Sydney