SYDNEY, Australia, Feb. 14 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that it will apply for Australian marketing approval of Bronchitol for patients with bronchiectasis, following a meeting with the Australian Therapeutic Goods Administration (TGA).
Bronchitol is being developed as a twice daily therapy for people with the incurable lung condition Bronchiectasis. The meeting with the TGA on 12 February was arranged following the successful completion of a Phase III clinical study of Bronchitol in the second half of 2007. The trial demonstrated a significant improvement in the quality of life for patients treated with Bronchitol, and a significant difference in their mucus clearance.
Pharmaxis will submit its marketing authorisation application following the conclusion of the ongoing safety component of the Phase III trial - an optional 12 month extension to determine the safety of long-term Bronchitol treatment. This component of the trial has had a high participation rate and a low withdrawal rate, and will complete mid-year. Pharmaxis will file the marketing application during the third quarter of 2008.
"We are delighted that our discussions with the TGA have provided a path forward for bringing Bronchitol to market in Australia," said Pharmaxis Chief Executive Officer Alan Robertson.
"More than 20,000 Australians suffer from bronchiectasis and Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in over 20 years -- addressing an important medical need."
Bronchiectasis is an incurable, degenerative and chronic lung condition that makes breathing difficult through excessive mucus build up in the lungs. Pharmaxis has the only product in Phase III clinical trials for bronchiectasis anywhere in the world.
Over 600,000 patients worldwide suffer from bronchiectasis. Total U.S.
medical care expenditure is US$13,000 per bronchiectasis patient, doub
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