GTC Biotherapeutics (fka GTCB)

[DewDiligence]

CC notes in no particular order
(see separate post re cash burn):

1. A US ATryn partnership in now expected during 2Q08. The first prospective partner pulled out (presumably around the time that LFB converted its preferred shares).

2. All ATryn partnerships talks include the CABG-HR indication (#msg-29022959), which GTC thinks is a $150-200M opportunity in US.

3. The final module of the ATryn BLA will be submitted at end of July. With a Priority Review, the FDA’s decision on the BLA will come six months from submission, i.e. in late Feb 2009. Notification about Priority review will comes after the BLA submission is complete.

4. A reverse-split authorization will be sought at the 2008 annual meeting. (I previously posted that GTC’s seeking RS authorization, which is not the same thing as actually executing a reverse split, was a sure thing.)

5. According to the terms of the LFB deal for AAT announced today, LFB will fund all of the preclinical development of this program during 2008. AAT is expected top enter the clinic during 2009.

6. The half-life of (non-inhaled) transgenic AAT is smaller than the half-life of plasma-derived AAT and hence GTC’s goal is to increase the half-life of transgenic AAT to match that of the plasma-derived drugs. (GTC will not comment on its method of accomplishing this, as has been noted on prior CC’s.)

7. Miscellaneous clinical updates: a) FIX will enter the clinic in late 2009; b) the first CD20 transgenic animals will be born in the fall of 2008; and c) GTC’s FoB development plan now includes 4-5 mAbs other than CD20.