Pharmaxis has announced that the United States Food and Drug Administration has granted an Orphan Drug status for the company's product Bronchitol, for the treatment of bronchiectasis.
Orphan drug status has been granted to Pharmaxis on the basis of Bronchitol's ability to aid the treatment of bronchiectasis, an incurable, degenerative and chronic inflammatory condition of the lungs affecting over half a million people worldwide. Orphan drug status entitles Pharmaxis to a range of incentives including a seven-year period of market exclusivity and study design assistance that will substantially contribute to rapid approval, a company release stated.
Alan Robertson, Pharmaxis chief executive officer said: "We are extremely pleased that Bronchitol has been granted Orphan Drug status by the FDA. With these concessions Bronchitol will proceed more quickly towards the international trials required for approval, and patients will receive benefits sooner."
In late 2004, Pharmaxis reported positive results from a two week Bronchitol study in patients with bronchiectasis. Most cases of bronchiectasis develop during childhood, some rare cases are present from birth. Bronchiectasis can be the result of infections such as pneumonia or the inhalation of irritating substances, causing inflammation of the bronchial wall.
Pharmaxis develops pharmaceutical products to treat human respiratory and autoimmune diseases. Its development pipeline of products includes Aridol for the management of asthma and PXS25 for the treatment of multiple sclerosis.