- Report of Foreign Issuer (6-K)
02 March 2009 - 10:12PM
Edgar (US Regulatory)
CONFORMED COPY
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1933
March 2, 2009
Pharmaxis Ltd
2/10 Rodborough Road,
Frenchs Forest, NSW 2086
Australia
(Indicate by check mark whether the registrant files or will file annual reports under cover of
Form 20-F or Form 40-F.)
Form 20-F
þ
Form 40-F
o
(Indicate by check mark whether the registrant by furnishing the information contained in this form
is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.)
Yes
o
No
þ
(If Yes is marked, indicate below the file number assigned to the registrant in connection with
Rule 12g3-2(b): 82- _______.)
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ASX/NASDAQ Media Release
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02 March 2009
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Pharmaxis Announces New Drug Application Submission for Aridol
TM
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 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.
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American Lung Association. Epidemiology & Statistics Unit, Trends in Asthma Morbidity and
Mortality 2007
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#ends#
SOURCE:
Pharmaxis Ltd, Sydney, Australia
CONTACT:
Alan Robertson Chief Executive Officer
Ph: +61 2 9454 7200 or email alan.robertson@pharmaxis.com.au
RELEASED THROUGH:
Australia:
Felicity Moffatt, phone +61 418 677 701 or email
felicity.moffatt@pharmaxis.com.au
United States:
Brandon Lewis, Trout Group, phone +1 646 378 2915 or email
blewis@troutgroup.com
Page 1 of 2
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 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 patients 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.
Page 2 of 2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Pharmaxis Ltd
(Registrant)
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Date: March 2, 2009
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By:
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/s/ David McGarvey
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Name:
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David McGarvey
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Title:
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Chief Financial Officer
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