Bloomberg News

EU Regulator Recommends Approval of Pharmaxis’s Bronchitol

October 21, 2011

(Adds description of medicine in third paragraph.)

Oct. 21 (Bloomberg) -- Pharmaxis Ltd., the Australian developer of an experimental treatment for cystic fibrosis, won a recommendation from a regulatory panel of the European Medicines Agency to market the company’s most-advanced drug.

The Committee for Medicinal Products for Human Use recommended Bronchitol as an add-on therapy for adult cystic fibrosis patients, reversing an earlier decision, the agency said today in a statement.

Bronchitol is an inhaled treatment designed to treat cystic fibrosis, an inherited disorder that causes build-up of sticky mucus in the airways, leading to lung damage and infections that can kill patients before they turn 40. Australian regulators approved the drug in February.

Pharmaxis shares were placed on a trading halt in Australia on Oct. 17 ahead of the recommendation. The stock fell 74 percent on May 25 after the European panel initially voted against approval of Bronchitol.

--Editor: Kristen Hallam, Bruce Rule

To contact the reporters on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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