GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Given the very poor commercial success of ATryn in Europe post approval (and LEO's apparent willingness to walk away from it,) I don't see how approval in the US for the HD indication does anything "substantial" for the company's valuation. Won't it be a commercial dog here too?<

There are several facets to the answer:

1. ATryn for the HD indication figures to have a much easier time gaining traction in the US than in Europe. First, there is no bona fide competition from plasma-derived antithrombin in the US as there is in the EU. (Thrombate from Talecris, the only approved AT in the US, is available only sporadically.)

Further, it will be much easier for Ovation to secure ATryn reimbursement in the US than it has been for Leo to secure reimbursement in the EU, where a sponsor must undertake drawn-out negotiations with the government of each individual EU country.

2. FDA approval of ATryn for HD opens up the US ATryn programs for CABG/HR and DIC (although Ovation seems to be interested mainly in the former). GTC’s prior clinical studies in CABG/HR may allow Ovation to proceed directly to phase-3 for this indication following FDA approval for HD.

3. FDA approval of ATryn for HD will presumably increase the interest of prospective partners in striking US FoB deals that exploit GTC’s low-cost manufacturing platform.