ALERTS100%to10000%GAIN
6 years ago
PRAN 1.42 in PM FDA NEWS Prana receives first orphan drug designation from the FDA for the treatment of Multiple System Atrophy
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA β 31st January 2019: Prana Biotechnology Ltd (ASX: PBT, NASDAQ: PRAN) (βPranaβ or βthe Companyβ) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its lead molecule, PBT434, for the treatment of Multiple System Atrophy (MSA). This is the first time the FDA has granted orphan designation to a drug for the treatment of MSA.
Orphan Drug designation by the FDA entitles Prana to seven years of market exclusivity for the use of PBT434 in the treatment of MSA and qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.
Pranaβs successful application was based on the proposed use of PBT434 as a treatment for MSA, including the medical and scientific rationale. The application articulated how PBT434 prevents a-synuclein accumulation, preserves neurons, and improves motor function in a widely accepted animal model of MSA. Alpha-synuclein is of great interest because aggregated forms of the protein are a pathological hallmark of Parkinsonian conditions, including MSA, and it represents a recognised therapeutic target by the scientific community.
βWe are pleased that the FDA has acknowledged the importance of PBT434 as a potential treatment for MSA. This recognition, in conjunction with the recent investment from Life Biosciences, positions us strongly to accelerate the development of PBT434 for this devastating condition,β said Dr David Stamler, Chief Medical Officer.
Prana has identified a clear unmet medical need with no approved treatments specifically for MSA. Prana is conducting a Phase 1 clinical trial of PBT434 and expects it to be completed this year.
ENDS
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tbtbtb
9 years ago
Yeah, it's been quiet here. Don't know why.
It's always tricky with PRAN, because you never know when things will change dramatically. But that's what makes it fun too. It sure was fun back when it soared all the way to 13 in a matter of days. Exhilarating! And then, not so exhilarating on the way down. You always wonder if Murphy's Law will hold whenever you sell or reclassify in your case, but ...
Anyway, you mentioned taxes. Does anyone have any thoughts about PRAN ADR's being classified as a FPIC at this time? The tax implications? I probably won't sell any of my shares until the company is generating revenue from PBT2 (hopefully), and thus no longer a PFIC, but I'm a little fuzzy on the implications there.
Kadaicher1
9 years ago
Hi RKF, the trial has identified plaque reduction. A statement they made on page 3 of the report was interesting, indicating no changes in measurements between 1yr and 2 yr.
http://pranabio.com/wp-content/uploads/2015/08/150826_Prana-Annual-Report-and-4E.pdf
That would be brilliant if the patients were more advanced, but the differences over one year in these earlier stage patients would possibly have been tiny. I would take from that data that PBT2 may have stopped or slowed AD in the second year but the trial is too small to be able to reach that conclusion. Still, no changes over one year is a good sign.
When Prana started the Reach2HD and IMAGINE trials it was always the plan that Reach2HD would lead PBT2 to market and IMAGINE was run to try to attract a pharma partner for the AD program with a demonstration of target engagement.
They are still on track with HD for phase3, and like you I don't think they will have a problem getting the partial hold lifted when the safety analysis and HD trial design are complete.