GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible / Probable News Flow in 2008-2009

[Updated for apparent delay in the CD137 program.]


1. FDA acceptance of the ATryn BLA for review, expected in late September or early October (45-60 days from the BLA submission date on 8/7/08). The relevance of the acceptance-for-review date is this is 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 monoclonal antibodies with FoB potential in which GTC has already developed founder animals. GTC claims to have spoken to prospective FoB partners and hence a deal 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 reporting of data in 2H09. 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. Dr. Cox has said that a deal is 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. GTC has given no guidance about when a CD137 partnership deal might be struck, but this is now unlikely to happen until late 2009 (#msg-31520428).