GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Since Kamada got Orphan Drug Designation for the Inhaled AAT,
does this mean that for 7 and 10 years (USA, Europe) other products including recombinant will be blocked?<

Good question.

If GTC ends up pursuing recombinant AAT for hereditary deficiency and Kamada obtains approval for marketing in the same indication, GTC will presumably try to break Kamada’s orphan designation by arguing that a recombinant product offers a significant safety advantage. For GTC investors, this is probably not worth worrying about until there is some indication that GTC will in fact pursue a clinical program in AAT.

Now a question for you: Why does Kamada have an orphan designation for the inhaled form of AAT but not for the injected form? T.i.a.