Australia’s Pharmaxis says that the US Food and Drug Administration (FDA) has designated the company’s Bronchitol (mannitol) as a fast-track product for cystic fibrosis, prompting a huge jump in its share price.
Both the FDA and the European Medicines Agency have previously granted Bronchitol orphan drug status for treating cystic fibrosis and the US regulatory authority will now give the product a speedy review before a complete New Drug Application is made in 2008.
Chief executive Alan Robertson said Phase II studies show the drug significantly improves lung function and wellbeing in patients with cystic fibrosis and the FDA decision “recognises the positive clinical data for Bronchitol.” The inhalable dry powder treatment improves mucus clearance in the lungs and is administered by a hand-held, pocket sized device.
Pharmaxis is currently conducting Phase III and II clinical trials of Bronchitol in cystic fibrosis patients at sites in Europe, Canada, Argentina and Australia. The company noted that the condition affects approximately 75,000 people in the developed world, a fifth of whom are children under five, and “there have been no treatment advances in over a decade, and no products are approved to improve lung hydration.”
News of the fast-track review was greeted with enthusiasm by US shareholders of Pharmaxis (it trades on the Nasdaq as well as the Australian Stock Exchange), rising almost 20% and hitting an all-time high at one stage of over $42.