Pharmaxis Announces Russian Approval for Bronchitol - Largest Market Accessed to Date
Release Date: 27/09/2016 8:30am
Pharmaceutical research company Pharmaxis (ASX: PXS) is pleased to announce its drug Bronchitol® has been approved for marketing in Russia for the treatment of both paediatric and adult cystic fibrosis (CF) patients. Russia is the largest market accessed to date for Bronchitol.
In a landmark decision Bronchitol today 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.
There are approximately 7,400 CF patients on the Russian Cystic Fibrosis Registry, but it is estimated there are between 3,000 and 6,000 CF patients living in rural regions not currently included on the registry. Last year the Russian market for CF drugs to deal with mucus clearance was approximately US$29 million. The first Russian sales of Bronchitol are expected before the end of 2016.
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