Navigation Links
ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
Date:9/30/2008

SYDNEY, Australia, Sept. 30 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that a marketing application for the mucus clearing agent, Bronchitol, has been submitted to the Therapeutic Goods Administration (TGA) division of the Australian Government. If approved, Pharmaxis will be authorized to market Bronchitol in Australia for the treatment of bronchiectasis.

The application is based on a multicentre Phase 3 clinical trial involving more than 360 subjects which evaluated the safety and efficacy of Bronchitol for inhalation in subjects with bronchiectasis. All of the 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.

After being accepted for evaluation, the TGA has 255 working days to review the application lodged by Pharmaxis.

There is currently no approved medication that specifically targets mucus clearance for people suffering from bronchiectasis.

Alan Robertson, Pharmaxis chief executive officer said: "We are delighted to announce this major milestone for Pharmaxis and believe this is 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."

It is estimated that more than 600,000 people in the major pharmaceutical markets suffer from bronchiectasis and Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in 20 years, addressing an important medical need. In Australia, it is believed that more than 18,000 people live with bronchiectasis and over 70% are moderately or severely incapacitated by their condition.

Bronchitol is also under development as a twice daily inhalation therapy for people with cystic fibrosis with two large Phase 3 trials currently underway.

CONTACT: Alan Robertson - Chief Executive Officer

Ph: +61 2 9454 7200 or email alan.robertson@pharmaxis.com.au

RELEASED THROUGH:

Australia:

Felicity Moffatt, phone +61 418 677701 or email

felicity.moffatt@pharmaxis.com.au

United States:

Brandon Lewis, Trout Group, phone +1 646 378 2915 or email

blewis@troutgroup.com

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.


'/>"/>
SOURCE Pharmaxis Ltd
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. New Data Support Role for Monitoring of Cell-Mediated Immunity in Adult Patients Following Renal Transplantation
2. New Data Support Earlier Suggested Guidance for Levels of Cell-Mediated Immunity in Pediatric Liver Transplant Patients
3. New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option
4. HealthMedia and Aetna to Study Online Insomnia and Depression Interventions
5. University of Miami Team Confirms Value of Monitoring Cell-Mediated Immunity Pre- and Post-Transplant in Management of Kidney Transplant Recipients
6. Penn State Hershey Transplant Program Uses Assay to Monitor Cell-Mediated Immunity
7. New Data From Phase 3 Study Suggests Tapentadol Immediate Release Effective for Acute Pain From Common Foot Surgery
8. Pharmacyclics Announces Preclinical Results Supporting Development of Its Novel Btk Inhibitor in Immune Mediated Diseases
9. Cardium and Tissue Repair Companys Excellarate Candidate for Healing Diabetic Wounds Gains Media Focus in Multiple Regions Across U.S.
10. Media Statement: MHA Keystone Center for Patient Safety & Quality OHRP Ruling
11. HealthMedias Strongest Single Quarter Results: Growth Driven by Product Enhancements, New Partnerships
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016  Guerbet announced today that it has been ... Award . One of 12 suppliers to ... its support of Premier members through exceptional local customer ... commitment to lower costs. ... our outstanding customer service from Premier," says Massimo ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Surgical Procedure Volumes: Global Analysis (United States, ... Australia, Canada)" report to their offering. ... an essential tool for healthcare business planners, provides surgical ... looks at surgery trends with an in-depth analysis of ...
(Date:6/23/2016)... June 23, 2016 The Biotechnology ... continues to present great opportunities to investors. Stock-Callers.com assesses ... Intrexon Corp. (NYSE: XON ), Vertex Pharmaceuticals ... (NASDAQ: ARNA ), and Regeneron Pharmaceuticals Inc. ... stocks and receive your complimentary trade alerts at: ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... ... , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business ... to $12 an hour by 2020 and then adjusting it yearly to increase at the ... minimum wage, assure the wage floor does not erode again, and make future increases more ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations at ... Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete ...
Breaking Medicine News(10 mins):