Replies to post #5413 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Collateral news re inhaled AAT:

>Assuming that Kamada’s inhaled AAT is approved by the FDA at some point… GTC might break Kamada’s orphan exclusivity by arguing that recombinant AAT is a significantly different product from plasma-derived AAT<

Today’s ATryn news suggests that the above argument will prevail. I.e., Kamada’s inhaled AAT will likely not block GTC from bringing its own inhaled AAT to market even though Kamada has an orphan designation.

This was the subject of a brief exchange on GTC’s most recent CC.

[genisi]

>Assuming that Kamada’s inhaled AAT is approved by the FDA at some point, there are two ways that I can see whereby GTC might break Kamada’s orphan exclusivity...<

I can see a third way:
Kamada has a small plant limiting their AAT production capability. They will be able to treat between 1000 to 3000 patients (dose for inhaled use is not known yet). More patients are being diagnosed every year due to better doc's awareness and rapid tests. GTCB will be able to break Kamada’s orphan exclusivity because Kamada will not manufacture enough AAT to meet the market demand.