SYDNEY, Australia, Nov. 23 /Xinhua-PRNewswire/ -- Pharmaceutical company
Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the US Food and Drug
Administration (FDA) has designated Bronchitol as a fast-track product for
cystic fibrosis.
The FDA fast-tracks the New Drug Application (NDA) process if a therapy
can potentially address an unmet medical need for a life-threatening
disease. Designation as a fast-track product is designed to expedite
regulatory review of the Bronchitol NDA. The FDA and European Medicines
Agency have both previously granted Bronchitol orphan drug status for
treating cystic fibrosis.
Pharmaxis chief executive officer Dr Alan Robertson said: "The FDA
decision is encouraging news for thousands of cystic fibrosis patients. It
recognises the positive clinical data for Bronchitol in treating cystic
fibrosis, which is a lethal inherited condition.
"This designation will speed the process of bringing this potentially
life-saving drug to cystic fibrosis sufferers.
"Phase II studies show Bronchitol significantly improves lung function
and wellbeing in patients with cystic fibrosis. We look forward to working
with the FDA on introducing Bronchitol to the U.S. market as rapidly as
possible."
Pharmaxis is currently conducting Phase III and II clinical trials of
Bronchitol in cystic fibrosis patients at sites in Europe, Canada, Argentina
and Australia.
Cystic fibrosis affects approximately 75,000 people in the developed
world, including 33,000 US patients and 2,500 Australians -- a fifth of whom
are children under five years old. There have been no treatment advances in
over a decade, and no products are approved to improve lung hydration.
Designation as a fast track product enables Pharmaxis to file the new
drug application on a rolling basis as data becomes available, allowing the
FDA to review the application in sections ahead of receiving the complete
submission. A complete submission is expected to be made in 2008.
Pharmaxis is developing Bronchitol as a treatment to improve mucus
clearance in the lungs of patients with cystic fibrosis, bronchiectasis and
chronic obstructive pulmonary diseases. Bronchitol is a patented, inhalable
dry powder formulation of mannitol administered by a hand-held, pocket sized
device.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
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 cannot 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: alan.robertson@pharmaxis.com.au
Released through:
United States:
Brandon Lewis, Trout Group
Tel: +1-212-477-9007
Email: blewis@troutgroup.com
Australia:
Virginia Nicholls
Tel: +61-417-610-824
Email: virginia.nicholls@pharmaxis.com.au