Antithrombin from yeast
What would stop Merck (with bio engineered yeast) from also getting approval and selling AT if GTCB gets approval in US for HD or in Europe for DIC?
That's a good question that got me to thinking.
I don't think GTCB/LEO would have a patent moat protecting them from a non-mammalian transgenic derived antithrombin. But, consider these obstacles that would face Merck/GlycoFi:
1) As a new drug, the Merck drug would be required to go thru essentially all of the approval steps, including conducting at least one phase III study.
2) Assuming Atryn is on the market in Europe, it will be even harder to find patients willing to participate in new studies for a drug that can't make a claim of superiority.
3) Antithrombin may actually be easier to produce in mammalian cells due to the difficulty posed by glycosylation. GlycoFi's strategy, I predict, will be to focus at least initially on easier to produce, less glycosylated proteins.
4) Why should Merck bother with the antithrombin market once Atryn is approved? There are zillions of other proteins, and plenty of riper plums in the market for them,IMO. Of course, it GTCB is able to succeed with Atryn in expanded conditions such as sepsis, DIC, burns, then the market would be more inviting to competitors. By then, we'll be fat, happy, or dead, so won't care.
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