Prana gets the orphan drug status it wanted and shares are looking 17pc healthier already
Health & Biotech
Health & Biotech
Prana Biotechnology has secured ‘orphan drug’ status for a drug candidate to treat multiple system atrophy, a disease that slowly attacks the nervous systems controlling movement and functions like blood pressure.
The powerful US Food and Drug Administration (FDA) gave the status to a Prana’s (ASX:PBT) lead molecule PBT434.
‘Orphan drug’ status is a designation that incentivises the creation of drugs for rare, otherwise commercially non-viable diseases.
“[This] entitles Prana to seven years of market exclusivity for the use of PBT434 in the treatment of multiple system atrophy and qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing,” the company said.
Prana shares rose 17 per cent to 4.1c on the news.
Prana’s orphan drug applications explained how the molecule prevents the build up of α‐ synuclein, a protein linked to Parkinson’s disease, and preserves neurons and improves motor function in animals.
Prana shifted its attention from Alzheimer’s to Parkinson’s in June 2018, turning its clinical focus to two forms of Parkinsonism with no existing treatments and orphan drug designation in the US and Europe.
And that change paid off shortly after Christmas with the news that biotech investor Life Biosciences was leading an initial $13.4m investment and a possible $31m via short-term warrants, a financial instrument similar to an option.