Navigation Links
Regulatory Path for Bronchitol in Bronchiectasis
Date:5/1/2008

SYDNEY, Australia, May 1 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (AXS: PSX; Nasdaq: PXSL) today announced that it has agreed with advice from the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 trial of the company's mucus clearing agent, Bronchitol, in patients with bronchiectasis.

The trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 300 adults with bronchiectasis. Participants will be treated for 52 weeks during which they will be assessed for reduction in frequency of exacerbations and quality of life. The trial will be undertaken in Europe and the USA.

This trial is the second Phase III study to be undertaken with Bronchitol in people with bronchiectasis and follows the completion of a successful trial reported during the third quarter of 2007. These trials are expected to form the basis of a marketing application in both the European Union and the U.S. Recruitment of volunteers will begin following receipt of the necessary approvals to begin the trial and is expected to be during the third quarter of 2008.

The clinical trial protocol requires final review by both the U.S. FDA under their Special Protocol Assessment (SPA) process and the European Medicines Agency, the EMEA.

The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a New Drug Application, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.

Alan Robertson (Pharmaxis CEO) said, "To ensure that this pivotal trial can start quickly and be completed efficiently, Pharmaxis has assembled a specific advisory board of opinion leading physicians in bronchiectasis and employed clinical and regulatory staff in the US and EU. There are no products specifically approved for bronchiectasis and Bronchitol remains the only product currently in the later stages of development for bronchiectasis. We are determined to make it available to patients worldwide as soon as possible."

Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis and chronic obstructive pulmonary diseases. Bronchitol is a patented, inhalable dry powder formulation of mannitol that is administered directly to the lungs through a convenient, breath activated and easy to use hand held device. The U.S. Food and Drug Administration has granted Bronchitol fast track status and it is designated as an orphan drug in the U.S. and Europe.

A large Phase III trial expected to form the basis of a marketing approval for Bronchitol in Europe in patients with cystic fibrosis is currently actively recruiting.

CONTACT: Alan Robertson - Chief Executive Officer

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

Released through:

United States: Brandon Lewis, Trout Group, phone +1 646 378 2915 or email blewis@troutgroup.com

Australia:

Virginia Nicholls, phone +61 417 610 824 or email virginia.nicholls@pharmaxis.com.au

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 cannot 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 biology technology :

1. Dr. Audrey F. Jakubowski of SuperGen Retires as Chief Regulatory and Quality Officer
2. FDA and Conformia Deliver Joint Presentation to Annual Regulatory and Compliance Symposium at Harvard
3. Thomson Scientific to Host Pharmaceutical Vision - A Users Conference for Information, Regulatory Affairs, Competitive Intelligence and Biotechnology Professionals
4. Cadence Pharmaceuticals Names Malvina Laudicina Vice President of Regulatory Affairs and Quality Assurance
5. Velcura Therapeutics, Inc. Appoints Industry Executive to Lead Regulatory Affairs
6. Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
7. Pearl Therapeutics, Inc. Expands Its Senior Management Team With Top Talent in Clinical Development and Regulatory Affairs
8. ExonHit Gets Regulatory Approval to Initiate a Phase 2 Clinical Trial for EHT 0202 in Alzheimers Disease
9. Kendle Appoints Former MHRA Head of Biologics as Principal Regulatory Affairs Consultant
10. Cephalons EFFENTORA Receives Positive Opinion from European Regulatory Authorities for the Management of Breakthrough Cancer Pain
11. Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016   Boston Biomedical ... novel compounds designed to target cancer stemness pathways, ... been granted Orphan Drug Designation from the U.S. ... of gastric cancer, including gastroesophageal junction (GEJ) cancer. ... designed to inhibit cancer stemness pathways by targeting ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network for ... Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is to ... are designed, built and brought to market. , The Design Lab is Supplyframe’s ...
(Date:6/23/2016)... BEACH, Calif. , June 23, 2016  Blueprint ... new biological discoveries to the medical community, has closed ... co-founder Matthew Nunez . "We have ... us with the capital we need to meet our ... will essentially provide us the runway to complete validation ...
Breaking Biology Technology:
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted ... quarter of 2015 The gross margin was 49% (27) ... the operating margin was 40% (-13) Earnings per share ... operations was SEK 249.9 M (21.2) , Outlook   ... M. The operating margin for 2016 is estimated to ...
(Date:4/15/2016)... -- Research and Markets has announced the ...  report to their offering.  ,      ... gait biometrics market is expected to grow at ... Gait analysis generates multiple variables such ... compute factors that are not or cannot be ...
(Date:3/29/2016)... RATON, Florida , March 29, 2016 ... or the "Company") LegacyXChange "LEGX" and SelectaDNA/CSI Protect are ... DNA in ink used in a variety of writing ... theft. Buyers of originally created collectibles from athletes on ... through forensic analysis of the DNA. ...
Breaking Biology News(10 mins):