Replies to post #4442 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Because there are already 3 approved AAT drugs for IV use in the market but none for use by Inhalation.<

OK—that makes sense. I know of plasma-derived AAT products from Talecris (#msg-11829819) and Purely Proteins (#msg-6488263). Who is the third vendor? T.i.a.

[DewDiligence]

Re: AAT and orphan exclusivity

This subject came up on today’s CC. Evidently, GTC isn’t concerned about Kamada’s orphan designation for inhaled AAT.

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:

1. By arguing that recombinant AAT is a significantly different product from plasma-derived AAT; or

2. By arguing that the GTC’s AAT has a significantly longer half-life than Kamada’s. (That GTC’s AAT is expected to have a longer half-life than the AAT products from other companies was first mentioned on today’s CC, and no details have been provided as to how this will be accomplished.)

In any case, GTC’s first AAT product will be injected rather than inhaled, and no one has orphan exclusivity for injected AAT. Hence the issue broached above is not one that requires an early resolution.

Comments welcome.