fda approves aridol phase 3 trial!, page-5

Pharmaxis Aridol trial at Phase III
December 23, 2004 - 12:59PM

Drug developer Pharmaxis will start a Phase III trial of its asthma test, Aridol, in the United States after the US regulatory authority accepted its Investigational New Drug application.

Pharmaxis said the clinical study in the US would involve about 150 patients.

The company recently completed a Phase III trial involving 600 patients in Australia, which enables Pharmaxis to apply for marketing authorisation in Australia and Europe.

"The IND is a significant step towards registering Aridol for sale in the US," Pharmaxis chief executive officer Alan Robertson said.

"The new trial will commence in 2005, and we expect its completion during the second half of that year.

"A successful outcome will open up the major US market for Pharmaxis and further expand the global reach of Aridol."

Pharmaxis said the potential global market for Aridol is more than $250 million.

Aridol is a lung-function test that allows doctors to diagnose the severity of a patient's asthma.
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The test uses an inhalable dry powder that can be administered using a hand-held device.