Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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Good question, Cookie - would demand for priority-review vouchers be great enough to warrant an auction? My guess would be yes: there must be a few deep-pocketed pharmas that would splurge on ensuring that one of their new treatments gain a speedier review - and quicker monetisation.
would they have a buyer lined up for the voucher or will they hold an auction?
Jim, That’s my understanding - the BoD wants this AMRYT to grow into a behemoth.
Maybe they should snap up ORPH while it's still cheap.
Currently around £170million market cap - down a lot from March/April highs
Not sure about that.
I think I read somewhere that Joe Amryt Wiley wants to create the next Shire Pharmaceutical.
I am of the opinion that the pipeline will not be developed there will be a bid for the company and someone else will develop.
Bermuda, Thanks for your articulate answer.
Prop,
Well they have that option of course and only AMYT can decide which is worth more - the sale value of the voucher now or saving it and using it to shorten the review period on the next product submitted for FDA approval. However, look at the pipeline, it's going to be a long while before they're sumbitting another NDA to the FDA on any of the other products and I suspect $100m now to fund the clinical development of that pipeline might be more useful.
Also, don't forget, Filsuvez was granted priority review by the FDA in its own right, no need to use a voucher even if they had one and given the field they're operating in, the same may well apply to future applications.
Would it not be better for us to keep the priority-review voucher for one of our future products? Or, have I missed an obvious point on how it works?
We were told at the end of last year that they were working on manufacture scale-up and preparing the supply chain in anticipation of approval. Apparently the product is now sitting at a speciality pharmacy, in pre-filled tubes ready for packaging and distribution. I'm not sure they've announced their plans in relation to global distribution yet.
As for AP103, it's still in preclinical development and has shown some very encouraging results producing similar collagen levels to viral gene therapies. The phase I/IIa trial is due to start in H2 next year.
A couple of questions...
Does Amryt have the capability to manufacture and distribute Filsuvez globally?
Whatever happened to the gene therapy for EB and where is that in development?
Someone seems to willing to pay $12.45 pre-market on NASDAQ
It's only a few short weeks until the FDA decision on Filsuvez and the EMA's CHMP decision follows shortly after that.
There is currently no FDA approved treatment specifically for EB, if approved Filsuvez would be the first and will have orphan drug exclusivity in Europe, the USA and Japan. Worth also remembering that FDA approval would also bring a priority review voucher which Amryt can sell on to the highest bidder. The going rate for PVs seems to be on the up again, perhaps a knock-on effect of Covid as companies look to overcome potential delays at the FDA. Last month Prometic Biotherapuetics sold their voucher for $105m.
Not only would FDA approval of Filzuvez be amazing news for EB sufferers, it would also be a major inflection point here with the added bonus of an instant windfall of potentially around $100m. So it wouldn't be at all surprising to see investors starting to take positions now.
https://liminalbiosciences.com/resources/press-releases-2021/liminal-biosciences-announces-sale-of-priority-review-voucher-for-usd105m
For the last few months there has been intermittent movement here, its like the mm's are trying to keep interest in the share but the price down.
Underlying this the company is making significant progress and that will manifest itself in price increase.