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.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
