SYDNEY, Australia, April 7 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd announced today that the Therapeutic Goods Administration (TGA) has reissued its Good Manufacturing Practices (GMP) Licence.
The Pharmaxis manufacturing facility in Sydney, Australia was first licensed by the TGA in May 2003 for the manufacture of inhalation powders for clinical trial purposes. Subsequent to an audit by the TGA earlier this year, the licence now authorises all steps in the manufacture of powders for inhalation for human use, with the exception of microbiological testing. Microbiological testing of Pharmaxis products is conducted under contract in certified laboratories.
Dr Alan Robertson, Chief Executive Officer said: ''We are now ready to supply for human use our leading inhalation products manufactured under the most controlled of conditions. This represents another important step on our quest to build an integrated business. We are looking forward to bringing our products to the international arena.’'
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
About Pharmaxis
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and autoimmune diseases. Its development pipeline of products include AridolTM for the management of asthma, BronchitolTM for cystic fibrosis and chronic obstructive pulmonary disease (COPD) and PXS64 for the treatment of multiple sclerosis.
Founded in 1998, Pharmaxis was listed on the Australian Stock Exchange in November 2003 (symbol PXS), and on NASDAQ (symbol PXSL) in August 2005. The company is headquartered in Sydney at its TGA-approved manufacturing facilities. For more information about Pharmaxis, go to www.pharmaxis.com.au or contact Jane Sugden, Investor Relations +61 2 9454 7230.
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 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 Ltd
CONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7200, +61-2-9451-3622; orBrandon Lewis of Trout Group for Pharmaxis, +1-212-477-9007, orblewis@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/
