Possible and Probable News Flow (supplement to chart in #msg-16969103):
1. Start of patient enrollment in phase-2 ATryn trial for 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 this any day inasmuch as GTC reported on the 3/5/07 CC that the clinical-trial sites have already been opened.
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 in the U.S. has low availability. GTC expects to complete patient enrollment in 2Q07, release top-line data in the second half of the year, and submit the BLA before year end.
3. ATryn launch in Europe. The official kickoff is at the International Society of Thrombosis and Haemostasis conference in July 2007. Although not much revenue is expected from this program during 2007, 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. A development partner for GTC’s CD137 program. This would be especially significant in that it would signify that GTC can once again be a player in monoclonal antibodies.
6. More deals similar to the ones with Merrimack and PharmAthene. The effect of such announcements on the stock price could be large, depending of course on the partner and the drug.
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