Pharmaxis Files for Aridol Approval in Korea

Pharmaxis Ltd
2007-07-09 13:06 671

- First Move Into Asia -

SYDNEY, Australia, July 8 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX:PXS; Nasdaq:PXSL) today announced its first step into the Asian market, filing for Korean marketing approval of its lung function test Aridol.

Aridol was recently approved for marketing in 13 European countries, and is already being sold in Sweden and Australia.

Korea is the first Asian country that Pharmaxis has filed a New Drug Application, and was chosen because of the high patient numbers and acceptance of bronchial provocation tests in diagnosing and managing respiratory disease.

"Korea has an estimated 2.5 million asthma sufferers and another 185,000 new asthma cases are being diagnosed every year," said Pharmaxis Chief Executive Officer Dr Alan Robertson.

"With seven to 15 per cent of asthma patients currently referred for a bronchial challenge test and up to 160,000 tests undertaken annually, Korea represents an important base from which to launch Aridol into the Asian market. We estimate our initial target Korean market to be 80,000 patients."

The Korean regulatory approval process is expected to complete in Q1 2008, after which Pharmaxis would seek reimbursement approval through the national health scheme. Pharmaxis plans to begin pre-marketing immediately approval is granted and is currently in discussion with potential Korean distribution partners to launch Aridol.

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.

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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.

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Source: Pharmaxis Ltd