Replies to post #7555 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>How about the P2 Atryn results for DIC / sepsis? Is Oct 08 still on for study completion?<

The most recent guidance is for top-line results around the end of 2008 (#msg-24216158, about one-third of the way down). However, GTC has no direct control over the timing of the phase-2 DIC study because is it falls under the auspices of Leo.

I’ll add this item to the news flow post—thanks for mentioning it.

[DewDiligence]

Possible / Probable News Flow

[Phase-3 data from US ATryn trial already out.]

1. A partnership for ATryn in the US. Now that the phase-3 ATryn study in the US is known to a success, a partnership announcement could come at any time. GTC has guided for an announcement during the current calendar quarter.

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. I would expect that partnership discussions will be accelerated now that the phase-3 ATryn trial in the US is known to be a success.

3. Submission and acceptance of the ATryn BLA for FDA review. Submission is expected in mid 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 the FDA decides at that time whether to conduct a Priority Review, which shortens the review time from 10 months to 6 months.

4. Results from the phase-2 ATryn study in DIC. The latest guidance (from GTC’s CC on 11/1/07) is for GTC’s European partner, Leo Pharma, to report top-line data around the end of 2008. This study will be closely watched by the investment community because DIC—and other acquired antithrombin deficiencies—address a much larger market than hereditary deficiency.

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. However, GTC has given no guidance about when a CD137 partnership deal might be struck.

6. Something else. This could be an additional program within the LFB collaboration or something out of the blue. With a company such as GTC that has so many possibilities, it’s not unreasonable to expect the unexpected.