Replies to post #5438 on GTC Biotherapeutics (fka GTCB)

[ThomasS]

Canada: I am a bit uneducated on this regulatory path: Do they just accept FDA and/or EU data for approval via some mutual recognition process?
tia

[n4807g]

Thanks for the transcript. To me this is the "keystone" to unlock the value of GTC. I hope that any US partner acknowledges the competitive advantage GTC enjoys and suggests other opportunities will be explored. What GTC needs is recognition by the investing community that they can be the Henry Ford of "chemical entity" production.

"It is the size of the markets for the portfolio products which are largely known chemical entities and which leverage the same production platform and infrastructure as ATryn. The uniqueness of our production technology provides a competitive advantage with these products by enabling us to produce large volumes of products at attractively competitive manufacturing costs and capital investment."

Going forward in time this country (and the world) will need lower cost drugs. When the investing community recognizes that GTC is positioned to make lower cost compounds this company will become a share price winner.

[dewophile]

"How will this longer half life be accomplished?

Geoffrey Cox

Well, actually, I can't answer you the question to that because that's sort of work in progress, to be quite honest. And so, that's still sort of a proprietary situation"

thanks for the transcript and this question during the cc. Aside from implications to AAT per se, its clear GTCB has yet another platform technology to add value in the FOB arena. It's early imo to put serious money in FOBs, but GTCB certainly seems poised as a future player with this three-pronged platform (cost advantages, enhanced ADCC, pK tweaking)

PS: my guess is pk modifications, like ADCC, involve modifications in glycosylation

[ThomasS]

Related to my survey selection of NVS partnering with GTCB in the USA re ATRYN, and understanding that NVS/Sandoz has collaborations with MNTA:

"Our previously demonstrated ability to produce large volumes of monoclonal antibodies has led us into the follow-on biologics or FOBs [#msg-23650024] …and we have initiated the first program in this strategy with CD20 monoclonal antibody, the same target at Rituxan. This is under our collaboration with LFB. We have already identified a number of further potential products for introducing to this portfolio, each with already established multi-billion dollar markets."

Q: What is the possibility of MNTA characterizing the "potential product" and GTCB producing it?