GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Possible/Probable 2006-07 News Flow:

[Listed in rough chronological order; revised with the addition of a partnership deal for AAT.]

1. MM-093 results from Merrimack. As GTC’s main non-ATryn partner, Merrimack Pharma will be in the spotlight with clinical data from two trials: the phase-2b in RA (data expected soon) and the phase-2 in psoriasis (data expected in late summer).

2. Start of phase-2 ATryn trial in DIC/sepsis by partner, Leo Pharma. This may not be a large news driver 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 before the end of 2006.

3. A partnership for alpha-1 antitrypsin (AAT), which has become GTC’s second most important internally-developed program. The transcript of the most recent CC highlights the importance of this program (#msg-12468464).

4. More Merrimack-like production deals. Timing is uncertain, but the effect of such announcements on the stock price could be large, depending of course on the partner(s) and the partnered drug(s).

5. A partnership for ATryn in Japan. This probably won’t happen until 2007, but there is some chance for an announcement this year. Japan has large existing sales of plasma-derived AT that are a juicy target for conversion to ATryn, but at least one Japanese clinical study (by a GTC partner) will be needed to obtain marketing approval.

6. 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 1Q07.

7. ATryn launch in Europe. This is expected in 2Q07 on a country-by-country basis following the completion of reimbursement discussions.