GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible / Probable News Flow

[Minor updates re timing.]

1. A partnership for ATryn in the US. This is apt to be the most consequential news item of the next 12 months (#msg-21999558). GTC lists this as a 2007 news item in #msg-23625770, but I would not interpret this too literally.

2. 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.

3. Reporting of top-line data from the US ATryn trial. This is planned for sometime in late 2007.

4. Submission and acceptance of the ATryn BLA for review. Submission is expected in mid 2008 and acceptance of the BLA for review occurs approximately 60 days after submission. The relevance of the acceptance-for-review date is that the FDA decides at that time whether to conduct a Priority Review, which shortens the review time from 10 months to 6 months. (With an FDA Fast Track designation for the ATryn program, Priority Review is likely but not assured.)

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.

6. Something out of the blue. With a company such as GTC that has so many possibilities, it’s not unreasonable to expect the unexpected. One possibility is a new supply deal similar to the one with Merrimack. The effect of such an announcement on the stock price could be large, depending of course on the partner and the partnered drug.