GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible / Probable News Flow in 2008-2009

[Updated for guidance on the 1Q08 CC.]


1. A partnership for ATryn in the US. GTC now admits that a deal fell through at the eleventh hour and this has evidently delayed the consummation of a partnership by about six months relative to GTC’s original guidance. The latest guidance is for a deal to be inked during 2Q08, which ends on June 30.

2. Submission and acceptance of the ATryn BLA for FDA review. Submission is expected in late July 2008 and FDA acceptance of the BLA for review occurs approximately 60 days after submission. The relevance of the acceptance-for-review date is that this is generally when the FDA decides whether to grant a Priority Review (which shortens the review time from 10 months to 6 months).

3. Results from the phase-2 ATryn study in DIC. The latest guidance from GTC’s partner, Leo Pharma, is for completion of enrollment by the end of 2008 and reporting of data in 1H09. This study will be closely watched by the investment community because DIC—and other acquired antithrombin deficiencies—address a much larger market than hereditary deficiency.

4. A partnership for ATryn in Japan. Japan has substantial sales of plasma-derived antithrombin, including an approved indication for DIC/sepsis. These plasma-derived sales represent low-hanging fruit for eventual conversion to ATryn. At least one Japanese clinical study (by a GTC partner) will be needed to obtain marketing approval. On the 3/6/08 CC, Dr. Cox said he thought a deal in 2009 was more likely than in 2008.

5. A development partner for the CD137 program. This would be significant because CD137 is the most advanced internal program that is not based on a plasma protein. However, GTC has given no guidance about when a CD137 partnership deal might be struck.

6. Something else. One possibility is a partnership for as yet undisclosed FoB’s for currently marketed antibody drugs that will soon go off-patent.