PHARMAXIS SUBMITS BRONCHITOL MARKETING APPLICATION
October 4th 2008 03:02
Wednesday October 1, 2008
Daily news on ASX-listed biotechnology companies
* GREY SEPTEMBER: SUNSHINE HEART UP 80%, BENITEC DOWN 44%
* TODAY: ASX, BIOTECHS UP: LIVING CELL UP 19%, AVEXA DOWN 6%
* PHARMAXIS SUBMITS BRONCHITOL MARKETING APPLICATION
* NUSEP IN $25m MERGER WITH NXGEN
* SYNCHROTRON GAINS HI-TECH COMPUTER; REMOTE RAPID ACCESS
* NORWOOD ABBEY SUSPENDED FOR ABSENT ACCOUNTS
* CHAIRMAN JOHN PRIEST LENDS APOLLO $2m
* DR SZE WEE TAN SYNDICATE TO TAKE CONTROL OF ROCKEBY
* OBJ LOSES DIRECTORS FOLLOWING LESS-THAN-SUCCESSFUL STUDY
* STARPHARMA RELEASES 3.6m ESCROW SHARES
To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
PHARMAXIS
Pharmaxis has submitted a marketing application for its mucous-clearing agent, Bronchitol to the Australian Therapeutic Goods Administration.
If approved, Pharmaxis will be authorized to market Bronchitol in Australia for the treatment of bronchiectasis.
The application is based on a multicentre phase III clinical trial involving more than 360 subjects which evaluated the safety and efficacy of Bronchitol for inhalation in subjects with bronchiectasis.
Pharmaxis said all primary efficacy end points were positive and statistically significant and Bronchitol was shown to be well tolerated with no serious adverse events attributed to treatment.
The company said the Therapeutic Goods Administration (TGA) had 255 working days to review the application.
Pharmaxis said there was no approved medication that specifically targets mucous clearance for people suffering from bronchiectasis.
Pharmaxis chief executive officer Dr Alan Robertson said it was a “major milestone … [and] an important development for people living with the incurable lung condition bronchiectasis”.
“Pharmaxis is dedicated to the development of safe and effective treatments for airway diseases, and we continue to work closely with regulatory authorities worldwide to bring Bronchitol to patients as quickly as possible,” Dr Robertson said.
Bronchitol is also under development as a twice daily inhalation therapy for people with cystic fibrosis with two large phase III trials currently underway.
Pharmaxis’ Aridol asthma test is available in both the European Union and Australia.
Pharmaxis fell seven cents or 3.11 percent to $2.18.
subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au
| 21 |
| Vote |
Add To: 
subscribe to this blog