GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible and Probable News Flow
(supplement to chart in #msg-14575474):

1. Start of phase-2 ATryn trial in DIC/sepsis by partner, Leo Pharma. This may not be a large news item per se, but it will help to cement the view that ATryn is more than just the hereditary-deficiency indication. Expect news on the initiation of this trial any day (it was originally slated for late 2006). For competitive reasons, mainly with respect to Artisan Pharma, the design of this trial will be kept under wraps by Leo to as great an extent as possible, However, investors may be able to glean some information from publicly available clinical-trial databases.

2. Completion of patient enrollment in the U.S. ATryn trial. The U.S. will be by far the most important market for ATryn because, unlike Europe and Japan, plasma-derived antithrombin is rarely available. Completion of patient enrollment is expected in 1H07 and a BLA is expected to be submitted to the FDA six months later.

3. ATryn launch in Europe. This is expected beginning in 2Q07 on a country-by-country basis following the completion of reimbursement discussions. Although not much revenue is expected from this program during 2006, the rollout will mark GTC’s transformation from an R&D company to a commercial enterprise.

4. A partnership for ATryn in Japan. Japan has substantial sales of plasma-derived antithrombin that form 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.

5. Another supply partnership similar to the one with Merrimack Pharma. Timing is uncertain, but the effect of such an announcement on the stock price could be large, depending of course on the partner and the drug.