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:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and ... women in the world, and the most handsome men, look naturally attractive. Plastic ...
Breaking Medicine News(10 mins):