Pharmaxis Announces New Drug Application Submission for ...( SYDNEY March 1 Asia-FirstCall/ -- Pha...),Health

SYDNEY, March 1 /PRNewswire-Asia-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS, Nasdaq: PXSL) today announced it had submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Aridol, a bronchial challenge test. Bronchial challenge tests are designed to help in the correct diagnosis and assessment of asthma. The structure and content of the NDA was based on a pre-NDA meeting with the FDA and follows the completion of two international randomized pivotal Phase 3 trials with Aridol involving over 1,000 subjects.

The NDA application is the vehicle through which Pharmaxis formally proposes that the FDA approve a new pharmaceutical for sale and marketing in the U.S. There is currently no FDA approved dry powder bronchial challenge test available in the U.S. and Aridol is the first test of this kind that comes complete and ready to use.

Alan Robertson, Pharmaxis Chief Executive Officer said: "We are delighted to announce this major milestone for Pharmaxis especially in light of the fact that this is believed to be the first such NDA submitted by an Australian company for a drug designed and developed in Australia. Pharmaxis is committed to the development of safe and effective products to help people living with lung diseases, and we look forward to working closely with the FDA over the coming months."

Asthma affects more than 34 million people in the U.S.(1) with an annual economic cost in the U.S. of $19.7 billion(1) and has a substantial impact on the health of a nation. Aridol was developed to assist with improving existing management strategies that help to control asthma and prevent worsening of its symptoms.

Aridol is approved for sale in most major European countries, Australia and Korea. Aridol has been included in the Global Initiative for Asthma
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