GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible / Probable News Flow in 2008-2009

[Updated for Ovation deal.]


1. 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).

2. One or more FoB partnerships. There are about half a dozen drugs with FoB potential (presumably mAbs) in which GTC has already developed founder animals. News could come at any time.

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 Ovation Pharma and the investment community because DIC addresses a much larger market than antithrombin 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 will be needed to obtain marketing approval. On the 3/6/08 CC, Dr. Cox said he thought a deal would be more likely in 2009 than in 2008.

5. A development partner for the CD137 oncology 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.