Pharmaxis Announces NDA Filing for Aridol(TM) (Mannitol Bronchial Challenge Test)
03 Marzo 2009 - 3:14PM
PR Newswire (US)
A Potential New Tool in the Diagnosis and Assessment of Asthma
EXTON, Pa., March 3 /PRNewswire/ -- Pharmaxis, Inc., a wholly owned
subsidiary of Pharmaxis Ltd (ASX:PXSASX:Nasdaq:ASX:PXSL), an
emerging respiratory specialty pharmaceutical company, announced
today that it has filed a New Drug Application (NDA),
electronically, with the U.S. Food and Drug Administration (FDA)
for Aridol(TM) (mannitol bronchial challenge test). Bronchial
challenge tests are designed to assess bronchial
hyperresponsiveness, an important marker in the diagnosis and
assessment of asthma. "A definitive asthma diagnosis and effective
monitoring and management of the disease have been long-standing
challenges for doctors and patients with asthma," said William
Storms, MD, Allergist, Colorado Springs, CO. "The primary method of
diagnosis -- a detailed history and physical examination of the
patient, has remained relatively unchanged for many years and is
largely absent of any routine test to confirm the diagnosis." Brett
Charlton MBBS, PhD, Medical Director, Pharmaxis Ltd, added, "Aridol
is designed to measure bronchial hyperresponsiveness that
corresponds with airway inflammation, an important underlying
component of asthma." Aridol will be a standardized test kit
containing proprietary dry-powder mannitol (a naturally occurring
sugar alcohol), prepared for delivery to the lungs using a
proprietary hand-held inhaler. The goal of Aridol is to provide
physicians and health care professionals with an objective measure
of active airway inflammation through an easy-to-use, single-use
test for asthma care and assessment in a variety of healthcare
settings. "Upon approval healthcare professionals will have an
easy-to-administer bronchial challenge test improving their ability
to diagnose and assess patients with asthma," said Stephen Beckman,
President, Pharmaxis, Inc. Aridol is approved for sale in
Australia, major European countries and Korea. It is the first and
only bronchial challenge test approved Europe-wide. Aridol has been
included in various asthma, sport and occupational screening
guidelines including; the GINA Report of Global Strategy for Asthma
Management and Prevention, the U.S. Asthma Management Guidelines,
the International Olympic Committee independent medical
commission's guidelines for beta-2 agonist use in the 2008 Summer
Olympics in Beijing, China, guidelines from the World Anti-Doping
Agency, and those issued by other sports-governing bodies to ensure
appropriate assessment and management of elite athletes who are
asthmatic. About Pharmaxis Pharmaxis is an emerging respiratory
specialty pharmaceutical company that researches, develops and
commercializes new therapies for undertreated respiratory diseases.
Its development pipeline includes: Aridol(TM) (mannitol bronchial
challenge test) a tool to diagnose and assess asthma;
Bronchitol(TM) (mannitol) 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 Ltd is headquartered in Frenchs Forest, Australia
with U.S. headquarters in Exton, PA. For more information, visit
http://www.pharmaxis.com/. DATASOURCE: Pharmaxis, Inc. CONTACT:
Marilyn Seiger, Kovak-Likly Communications, +1-203-762-8833, , for
Pharmaxis, Inc. Web Site: http://www.pharmaxis.com/
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