Biotech Values

[DewDiligence]

Re: ATryn, sepsis, and burns

>>AT III was supplied by Aventis (was this human plasma-derived or recombinant?)<<

It was plasma-derived. (ATryn is the only recombinant antithrombin.)

>>Have the conclusions of this [sepsis] trial been addressed by GTCB management and if so, why do they think ATryn will be effective for other forms of aquired deficiency.<<

For acquired (i.e. non-hereditary) antithrombin deficiency, each indication must be evaluated on its own merits. Based on the trials conducted to date, sepsis appears to be an indication where antithrombin augmentation has little if any clinical benefit. Sepsis in not in GTCB’s development plans.

The lead ATryn indication GTCB is pursuing for acquired antithrombin deficiency is burns. Once ATryn is approved for hereditary deficiency in Europe and the stress of obtaining the first approved indication is removed, GTCB is likely to move aggressively on starting a U.S. pivotal trial in burns (while the U.S. pivotal trial in HD is in progress).

Why should we expect antithrombin augmentation to work better in burns than in sepsis? One reason is that burns is an indication where the anti-inflammatory—as opposed to the anticoagulant—aspect of antithrombin may come into play.