bronchitoltm approved for patient use 12 May 2005BRONCHITOLTM...

bronchitoltm approved for patient use 12 May 2005
BRONCHITOLTM APPROVED FOR PATIENT USE UNDER THE SPECIAL
ACCESS SCHEME
Pharmaxis (ASX:PXS) announced today that the Therapeutic Goods Administration (TGA)
has approved several requests to supply its unapproved drug, Bronchitol, to patients with
bronchiectasis who participated in recent clinical trials.
The TGA requires that pharmaceuticals are approved and registered before they can be
supplied. Exemptions are occasionally granted under the Special Access Scheme (SAS)
for the supply of unapproved pharmaceuticals such as Bronchitol, to seriously ill patients.
Each request is considered individually, on a patient-by-patient basis.
Under the SAS, a patient‘s doctor applies to the TGA for approval to request the needed
drug from the manufacturer. Patients, doctors and the manufacturer are all obliged to
carefully monitor and report the safety of the drug and the balance of its benefits and risks.
In these cases, Pharmaxis will supply Bronchitol to a number of patients in NSW and
Victoria.
Pharmaxis CEO Alan Robertson said ‘This is a wonderful opportunity for Pharmaxis to help
people living with bronchiectasis. To breathe easily is something most people take for
granted: making that possible for these patients is very gratifying.’
Bronchitol is still in development. Clinical studies have shown it to be well tolerated, safe
and effective in stimulating mucus hydration and clearance in people with chronic
obstructive lung diseases. In particular, Bronchitol has been shown to dramatically
increase mucus clearance from the lungs and significantly improve quality of life for people
with bronchiectasis. Pharmaxis’ Phase II clinical trials for bronchiectasis are complete and
Phase III pre-registration trials are beginning.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.
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Page 2 of 2 ASX/Media release – Pharmaxis/bronchiectasis
For additional information, please contact:
Alan Robertson - Pharmaxis Chief Executive Officer
Ph: (02) 9454 7202 or [email protected]
Released through:
Ashley Rambukwella – Financial & Corporate Relations
Ph: (02) 8264 1004 / m. 0407 231 282 or [email protected]
About Pharmaxis Ltd
Pharmaxis (ACN 082 811 630) develops innovative pharmaceutical products to treat
human respiratory and autoimmune diseases. Its pipeline of products include AridolTM for
the management of asthma, BronchitolTM for cystic fibrosis and chronic obstructive
pulmonary disease (COPD) and PXS64 for the treatment of multiple sclerosis.
Founded in 1998, Pharmaxis was listed on the Australian Stock Exchange in November
2003 and is traded under the symbol PXS. The company is headquartered in Sydney at its
TGA-approved manufacturing facilities.
For more information about Pharmaxis, go to www.pharmaxis.com.au or call +61 2 9454
7200.
About BronchitolTM
Pharmaxis Ltd is developing BronchitolTM for the management of chronic obstructive lung
diseases including cystic fibrosis, bronchiectasis and chronic bronchitis.
Bronchitol is a proprietary formulation of mannitol administered in a convenient hand-held,
pocket-sized inhaler. Its formulation as a dry powder with a four-way action helps restore
normal lung clearance mechanisms.
About bronchiectasis
Pronounced ‘brong-kee-eck-tah-sis’, bronchiectasis is one of the chronic obstructive
pulmonary diseases, or COPDs, and affects children and adults. It is often mistaken for
asthma or pneumonia and misdiagnosis is common. In this disease the bronchial tubes
become irreversibly enlarged, forming pockets that can become infected. The bronchi walls
are damaged, causing impairment to the lung’s complex cleaning system. The tiny hairs, or
cilia, which line the bronchial tubes and sweep them free of dust, germs and excessive
mucus are unable to function properly. The result is that matter such as mucus and bacteria
accumulates affecting the performance of the lungs and the quality of life of the individual.