GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Clinical, Preclinical Goals for 2008-2009

[This chart, which comes from the BIO webcast
on 10/10/07, is the first time GTC has extended
the timeline into 2009. It may be compared to the
2007-2008 chart in #msg-23010729 to see what
has been added and changed. Please see the
notes below for the salient features.]



Notes:

1. The ex-US ATryn program in HD now has timeline entries for submission and approval in Canada. (Commercialization in Canada falls under the auspices of Leo Pharma.)

2. The timing of the ATryn DIC program in Europe is unchanged, but the timeline has now been extended out far enough to show the start of phase-3 in late 2009.

3. A US partnership for Atryn is now shown as a 2007 event, but I would not interpret this too literally. (The announcement of a US ATryn partnership was not shown on prior versions of this chart.)

4. The ATryn BLA (i.e. the final module of the “rolling” BLA) is now slated for submission in mid 2008, which is a slight slippage from prior guidance. However, Priority Review, which is likely but not assured, would shave four months off the FDA’s review period, allowing the FDA to act on the BLA by late 2008 or very early 2009 if there is no further delay.

5. The IND for the FVIIa program has been pushed out about a year from late 2008 to late 2009. (An IND as soon as late 2008 always seemed unrealistic given that this program still has considerable preclinical testing to be done, so I’m not sure why the old timeline was so aggressive.)

6. The INDs for AAT and CD137 have been pushed out from late 2008 to early 2009. (Ditto the remark above about FVIIa.)

7. The CD20 timeline shows preclinical development during 2009 following the completion of the production herd in 2008. An IND will presumably come in 2010, although the timeline does not extend that far out.