ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol...

ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for
Bronchitol in Australia

SYDNEY, Australia, Sept. 30 /Xinhua-PRNewswire-FirstCall/ --
Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that
a marketing application for the mucus clearing agent, Bronchitol, has been
submitted to the Therapeutic Goods Administration (TGA) division of the
Australian Government. If approved, Pharmaxis will be authorized to market
Bronchitol in Australia for the treatment of bronchiectasis.
The application is based on a multicentre Phase 3 clinical trial involving
more than 360 subjects which evaluated the safety and efficacy of Bronchitol
for inhalation in subjects with bronchiectasis. All of the primary efficacy
end points were positive and statistically significant, and Bronchitol was
shown to be well tolerated with no serious adverse events attributed to
treatment.
After being accepted for evaluation, the TGA has 255 working days to
review the application lodged by Pharmaxis.
There is currently no approved medication that specifically targets mucus
clearance for people suffering from bronchiectasis.
Alan Robertson, Pharmaxis chief executive officer said: "We are delighted
to announce this major milestone for Pharmaxis and believe this is an
important development for people living with the incurable lung condition
bronchiectasis. Pharmaxis is dedicated to the development of safe and
effective treatments for airway diseases, and we continue to work closely with
regulatory authorities worldwide to bring Bronchitol to patients as quickly as
possible."
It is estimated that more than 600,000 people in the major pharmaceutical
markets suffer from bronchiectasis and Pharmaxis expects Bronchitol to be the
first targeted medication for this patient group in 20 years, addressing an
important medical need. In Australia, it is believed that more than 18,000
people live with bronchiectasis and over 70% are moderately or severely
incapacitated by their condition.
Bronchitol is also under development as a twice daily inhalation therapy
for people with cystic fibrosis with two large Phase 3 trials currently
underway.
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 677701 or email
felicity.moffatt@pharmaxis.com.au

United States:
Brandon Lewis, Trout Group, phone +1 646 378 2915 or email
blewis@troutgroup.com

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.
SOURCE Pharmaxis Ltd

Alan Robertson, Chief Executive Officer, +61 2 9454 7200,
alan.robertson@pharmaxis.com.au, or Australia, Felicity Moffatt, +61 418
677701, felicity.moffatt@pharmaxis.com.au; or United States, Brandon Lewis,
Trout Group, +1-646-378-2915, blewis@troutgroup.com, all for Pharmaxis Ltd