Pharmaxis first to gain approval under Russia's new orphan drug system

28 September 2016

Australia’s Pharmaxis (ASX: PXS) says that its Bronchitol, a dry-powder mannitol formulation, has been approved for marketing in Russia for the treatment of both pediatric and adult cystic fibrosis (CF) patients.

Russia is the largest market accessed to date for Bronchitol and the news pushed the firm’s share price is up 7.5% intraday to A$0.285.

In a landmark decision Bronchitol became the first medicine to be processed under new Russian laws to provide patients access to innovative medicines. The new orphan drug legislation was announced by the Russian Ministry of Health in January 2016, and Bronchitol was designated as an orphan drug the following month.

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