SYDNEY, Jan. 16 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced the Korean regulatory agency has granted marketing approval for its asthma management product, Aridol.
"This is the first Asian approval of Aridol," said Pharmaxis Chief Executive Officer Dr Alan Robertson. "Korea is an important base from which to launch and grow Aridol in Asia. There are an estimated 2.5 million asthma sufferers and yet only 160,000 bronchial challenge tests are performed annually to assist with asthma diagnosis and management. The existing broad acceptance of lung function challenge tests presents a firm opportunity for marketing Aridol."
Approval by the Korean regulatory agency was based on the Australian approval and was completed efficiently in just six months.
The Korean pharmaceutical market is one of the twenty largest in the world and together with its Korean distributor BL&H Co Ltd, Pharmaxis will now commence pre-marketing while seeking reimbursement approval through the national health scheme.
The approval process is expected to conclude in the third quarter of 2008.
A simple to use airways inflammation test, Aridol is administered as a
dry powder in a hand held inhaler. Doctors can use the results of this test
to identify airway hyper-responsiveness -- a hallmark of asthma.
To find out more about Pharmaxis go to http://www.pharmaxis.com.au .
To find out more about Aridol go to http://www.aridol.info .
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."
Alan Robertson, Chief Executive Officer
Brandon Lewis, Trout Group
|SOURCE Pharmaxis Ltd|
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