U.S. FDA Accepts Aridol(TM) New Drug Application for Review
14 5월 2009 - 8:33AM
PR Newswire (US)
SYDNEY, Australia, May 13 /PRNewswire-Asia/ -- Pharmaxis (ASX:PXS)
( NASDAQ: PXSL) today announced it had received notification from
the United States Food and Drug Administration (FDA) that the New
Drug Application (NDA) for its mannitol bronchial challenge test
Aridol(TM) has been accepted for standard review. The FDA will
advise the result of the review on 27 December 2009. Pharmaxis is
seeking approval for Aridol for "the assessment of bronchial
hyperresponsiveness to aid in the diagnosis of patients with
symptoms of or suggestive of asthma." Asthma affects more than 34
million people in the U.S. with an annual economic cost of $19.7
billion. When approved, Aridol will be the first dry powder
bronchial challenge test available in the U.S. Alan Robertson,
Pharmaxis Chief Executive Officer said: "We have been greatly
encouraged by the interest respiratory physicians have shown in
Aridol at recent U.S. scientific conferences. We estimate that
200,000 bronchial hyper-responsiveness tests are performed in the
US each year and hope that the introduction of a dry powder test
kit will encourage more physicians to utilize this test when
diagnosing asthma. We look forward to working with the FDA to
complete the review." Aridol is approved for sale in most major
European countries, Australia and Korea. Aridol has been included
in the Global Initiative for Asthma guidelines, and in the U.S.
Asthma Management Guidelines. It is one of the tests recommended by
the World Anti-Doping Agency, and other sports governing bodies to
ensure elite athletes who are asthmatic are properly diagnosed and
treated. 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. CONTACT: Alan Robertson Chief Executive Officer Tel:
+61-2-9454-7200 Email: RELEASED THROUGH: Australia: Felicity
Moffatt Tel: +61-418-677-701 Email: United States: Brandon Lewis
Trout Group Tel: +1-646-378-2915 Email: DATASOURCE: Pharmaxis Ltd
CONTACT: Alan Robertson, +61-2-9454-7200, ; Felicity Moffatt,
+61-418-677-701, , both of Pharmaxis; Brandon Lewis of Trout Group
for Pharmaxis, +1-646-378-2915, Web site:
http://www.pharmaxis.com.au/
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