ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
01 Ottobre 2008 - 2:19AM
PR Newswire (US)
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 RELEASED THROUGH: Australia: Felicity Moffatt, phone
+61 418 677701 or email United States: Brandon Lewis, Trout Group,
phone +1 646 378 2915 or email 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 Ltd
CONTACT: Alan Robertson, Chief Executive Officer, +61 2 9454 7200,
, or Australia, Felicity Moffatt, +61 418 677701, ; or United
States, Brandon Lewis, Trout Group, +1-646-378-2915, , all for
Pharmaxis Ltd
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