SYDNEY, Australia, Oct. 6 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd has received approval from the U.K. Medicines Healthcare products Regulatory Agency (MHRA) to begin the UK arm of an international Phase III clinical trial to evaluate Bronchitol in patients suffering from cystic fibrosis.
Alan Robertson, Pharmaxis Chief Executive Officer said: 'This Phase III trial for Bronchitol is the final clinical step before we seek registration for Bronchitol in the European Union and follows the successful Phase II cystic fibrosis trial reported late last year. When successfully completed, the results of the study should provide sufficient data for a European marketing application to be lodged.'
The trial design has been constructed following meetings with the European regulatory agencies and will investigate the effectiveness of Bronchitol in the treatment of cystic fibrosis. It will be conducted across Europe and Australia and subjects will be assessed for improvements in lung function, exacerbations, and quality of life.
Dosing of subjects is expected to commence in the first quarter of 2007 and full patient recruitment is expected to take about 12 months. Subjects will receive treatment for 6 months. Results are expected to be available mid 2008.
Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, hand-held, pocket sized device. Both the United States Food and Drug Administration and the European Medicines Agency have granted orphan drug status for Bronchitol for the treatment of cystic fibrosis.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
For more information about the trial and Bronchitol, please go to page 2 of http://www.pharmaxis.com.au/library/2006_10_06_CF301_trial_approval.pdf
Forward-Looking Statements
The statements contained in this press 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 press 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 press 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.
Contact: Alan Robertson Chief Executive Officer Tel: +61-2-9454-7200 Fax: +61-2-9451-3622 Released through: United States: Brandon Lewis Trout Group Tel: +1-212-477-9007 Email: blewis@troutgroup.com Australia: Ashley Rambukwella Financial & Corporate Relations Pty Ltd. Tel: +61-2-8264-1004 or +61-407-231-282 Email: a.rambukwella@fcr.com.au
Pharmaxis LtdCONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7200 or fax, +61-2-9451-3622; or Brandon Lewis of Trout Group for Pharmaxis, +1-212-477-9007,or blewis@troutgroup.com; or Ashley Rambukwella of Financial & CorporateRelations Pty Ltd. for Pharmaxis, +61-2-8264-1004, or +61-407-231-282, ora.rambukwella@fcr.com.au
Web site: http://www.pharmaxis.com.au/
