Pharmaxis Announces New Drug Application Submission for Aridol(TM)
March 01 2009 - 4:41PM
PR Newswire (US)
SYDNEY, March 1 /PRNewswire-Asia-FirstCall/ -- Pharmaceutical
company Pharmaxis (ASX:PXSASX:Nasdaq:ASX: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 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. Reference 1. American Lung Association. Epidemiology &
Statistics Unit, Trends in Asthma Morbidity and Mortality 2007
CONTACT: Alan Robertson - Chief Executive Officer Ph: +61 2 9454
7200 or email RELEASED THROUGH: Australia: Felicity Moffatt, phone
+61 418 677 701 or email United States: Brandon Lewis, Trout Group,
phone +1 646 378 2915 or email 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 immune disorders. Its development
pipeline of products includes Aridol for the management of asthma,
Bronchitol for cystic fibrosis, bronchiectasis and chronic
obstructive pulmonary disease (COPD), PXS25 for the treatment of
lung fibrosis and PXS4159 for asthma. Founded in 1998, Pharmaxis is
listed on the Australian Securities Exchange (symbol PXS), and on
NASDAQ Global Market (symbol PXSL). The company is headquartered in
Sydney at its TGA-approved manufacturing facilities. For more
information about Pharmaxis, go to http://www.pharmaxis.com.au/ or
contact Investor Relations on phone +61 2 9454 7200. About Aridol
Asthma is among the top 10 most commonly cited reasons for
consulting a General Practitioner (GP). Yet GPs currently rely upon
older tests that are often inaccurate and cumbersome to assess
airway inflammation in patients with asthma. The easy to administer
test uses a patented formulation of mannitol processed into a
breathable powder. The test requires the patient to inhale
increasing doses of Aridol, which causes the airways to narrow and
contract that is simply detected by measuring the amount of air a
person can exhale in one second. The smaller the dose required to
cause contraction, the more severe the patient's asthma diagnosis.
People without airway inflammation do not respond to an Aridol
challenge test. 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. DATASOURCE: Pharmaxis CONTACT: Alan Robertson, Chief
Executive Officer, +61 2 9454 7200, , Australia: Felicity Moffatt,
+61 418 677 701, , both of Pharmaxis; United States: Brandon Lewis,
Trout Group, +1-646-378-2915, , for Pharmaxis Web Site:
http://www.pharmaxis.com.au/
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