Navigation Links
Pharmaxis to Apply to Market Bronchitol in Australia

SYDNEY, Australia, Feb. 14 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that it will apply for Australian marketing approval of Bronchitol for patients with bronchiectasis, following a meeting with the Australian Therapeutic Goods Administration (TGA).

Bronchitol is being developed as a twice daily therapy for people with the incurable lung condition Bronchiectasis. The meeting with the TGA on 12 February was arranged following the successful completion of a Phase III clinical study of Bronchitol in the second half of 2007. The trial demonstrated a significant improvement in the quality of life for patients treated with Bronchitol, and a significant difference in their mucus clearance.

Pharmaxis will submit its marketing authorisation application following the conclusion of the ongoing safety component of the Phase III trial - an optional 12 month extension to determine the safety of long-term Bronchitol treatment. This component of the trial has had a high participation rate and a low withdrawal rate, and will complete mid-year. Pharmaxis will file the marketing application during the third quarter of 2008.

"We are delighted that our discussions with the TGA have provided a path forward for bringing Bronchitol to market in Australia," said Pharmaxis Chief Executive Officer Alan Robertson.

"More than 20,000 Australians suffer from bronchiectasis and Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in over 20 years -- addressing an important medical need."

Bronchiectasis is an incurable, degenerative and chronic lung condition that makes breathing difficult through excessive mucus build up in the lungs. Pharmaxis has the only product in Phase III clinical trials for bronchiectasis anywhere in the world.

Over 600,000 patients worldwide suffer from bronchiectasis. Total U.S. medical care expenditure is US$13,000 per bronchiectasis patient, double that of patients without the disorder; and an increased overall cost of US$630 million. Widespread availability of high resolution scanners is leading to increasing diagnosis and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a daily treatment administered by inhalation to the patient's lungs.

To find out more about Pharmaxis go to .

Forward-Looking Statements

The statements contained in this media release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this media release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the potential for Aridol and/or Bronchitol. All forward-looking statements included in this media release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. We can not guarantee that any product candidate will receive FDA or other regulatory approval or that we will seek any such approval. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors and Other Uncertainties" section of our Form 20-F lodged with the U.S. Securities and Exchange Commission.


Alan Robertson -- Chief Executive Officer

Tel: +61-2-9454-7200


Released through:


Virginia Nicholls,

Tel: +61-417-610-824


United States:

Brandon Lewis, Trout Group,

Tel: +1-646-378-2915


SOURCE Pharmaxis
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Phase III Trial Finds Pharmaxis Bronchitol Effective
2. Pharmaxis Announces Placement of $50 Million and Share Purchase Plan
3. Pharmaxis Closes Share Purchase Plan
4. Pharmaxis Appoints Portuguese Distributor for Aridol
5. Pharmaxis Aridol Gains First Asian Approval
6. Pharmaxis Investor Conference Call
7. DAIICHI SANKYO EUROPE is Applying for Approval of its New Combination Product of Olmesartan and Amlodipin
8. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
9. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
10. InterCure and Omron Healthcare (UK) Ltd. Announce Marketing Collaboration for Hypertension Market in United Kingdom
11. Kendle to Ring Opening Bell at NASDAQ Stock Market on August 22
Post Your Comments:
(Date:10/10/2017)... ... October 10, 2017 , ... For the second time ... US2020 STEM Mentoring Award. Representatives of the FirstHand program travelled to Washington, D.C. ... US2020. , US2020’s mission is to change the trajectory of STEM education in ...
(Date:10/10/2017)... , Oct. 10, 2017 SomaGenics announced the ... NIH to develop RealSeq®-SC (Single Cell), expected to be ... small RNAs (including microRNAs) from single cells using NGS ... the need to accelerate development of approaches to analyze ... "New techniques for measuring levels of mRNAs ...
(Date:10/9/2017)...  BioTech Holdings announced today identification and patenting ... stem cell therapy prevents limb loss in animal ... that treatment with ProCell resulted in more than ... to standard bone marrow stem cell administration.  Interestingly, ... of therapeutic effect.  ...
(Date:10/9/2017)... Phoenix, Arizona (PRWEB) , ... October 09, 2017 ... ... of Kindred, a four-tiered line of medical marijuana products targeting the needs of ... production and packaging of Kindred takes place in Phoenix, Arizona. , As operators ...
Breaking Biology Technology:
(Date:6/14/2017)... IBM ) is introducing several innovative partner startups at VivaTech ... startups and global businesses, taking place in Paris ... will showcase the solutions they have built with IBM Watson ... France is one of the most dynamic ... in the number of startups created between 2012 and 2015*, ...
(Date:4/24/2017)... , April 24, 2017 ... and partner with  Identity Strategy Partners, LLP (IdSP) ... "With or without President Trump,s March 6, 2017 ... Terrorist Entry , refugee vetting can be instilled with ... resettlement. (Right now, all refugee applications are suspended ...
(Date:4/13/2017)... According to a new market research report "Consumer IAM Market ... Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region - Global Forecast ... from USD 14.30 Billion in 2017 to USD 31.75 Billion by 2022, ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):