Replies to post #6178 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

FDA approves room-temperature formulation
of NovoSeven with a shelf life of two years:

http://www.reuters.com/article/marketsNews/idINN0950102820080509

[DewDiligence]

How is Novo Nordisk preparing for NovoSeven patent expiration?

[Updated for NN7128 completion of phase-1.]


NVO’s blockbuster rFVIIa drug, NovoSeven, goes off-patent in the US—its largest market—in 2011. NVO has a two-pronged approach to deal with this predicament:

1. A fast-acting FVIIa analog called NN1731, which is in phase-2:
http://seloken.com/secNewsItem/Variant-rFVIIa-more-active-than-NovoSeven.aspx . (Note that fast acting is not the same thing as short acting.)

2. A long-acting FVIIa analog called NN7128 based on pegylation technology from NTEC, which has completed phase-1 (#msg-29710045).

Clearly, both of these programs warrant close attention by GTC investors. However, these two drug candidates are FVIIa analogs, not FVIIa per se. Thus, they would seem to incur a higher regulatory risk than the FVIIa program from GTC and LFB.