Australian CF drug approved in Russia

Cystic fibrosis drug Bronchitol, from pharmaceutical research company Pharmaxis (ASX:PXS), has been approved for marketing in Russia for the treatment of both paediatric and adult CF patients. The drug is the first medicine to be processed under new Russian laws to provide patients access to innovative medicines, announced in January 2016.

Bronchitol is a precision spray-dried form of mannitol, delivered to the lungs by a portable inhaler, which improves drainage of the bronchus-pulmonary system. It will be manufactured in Pharmaxis’s Sydney facility and exported to Russia, where it will be used to treat CF patients aged six and above.

Russia is the largest market accessed to date for Bronchitol, with approximately 7400 CF patients on the Russian Cystic Fibrosis Registry and an estimated 3000–6000 rural patients not included on the registry. There are 40 cystic fibrosis centres for children and three for adult patients in Russia, along with some small centres located within the pulmonology departments of paediatric hospitals.

Russia’s Ministry of Health Orphan Committee will now consider Bronchitol’s application for reimbursement under the country’s program for guaranteed funding of seven orphan diseases, known as the 7 Nosologies Program. The president of Russia’s association for patients with cystic fibrosis, Professor Nikolay Kapranov, believes the vast majority of CF patients will be able to have free access to the product once it is included in the program.

Pharmaxis was supported in its application by its Russian distributor, who will provide in-country logistical support for Bronchitol. Pharmaxis will also engage the services of four CF medical specialists to support the use of Bronchitol in the clinic. The first Russian sales of the drug are expected before the end of the year.

Pharmaxis (ASX:PXS) shares were trading 7.55% higher at $0.285 as of around 1.30 pm on Tuesday.