GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Grifols, the Madrid-based plasma company, is running a phase-2/3 U.S. trial to test plasma-derived AT in hereditary deficiency. The trial will enroll 30 patients in a single arm (i.e. no control arm) at one site in Texas. It is expected to be completed in May, 2008:

http://www.clinicaltrials.gov/ct/show/NCT00319228?order=2

If there is no hitch, Grifols’ antithrombin could be approved by the FDA in late 2009—about a year after ATryn—and it would become the second plasma-derived AT in the U.S. (along with Thrombate from Talecris).

However, the real question is why any doctor would want to prescribe plasma-derived AT when a recombinant product (ATryn) is available that does not subject patients to the risk of blood-borne diseases (#msg-7306242, #msg-4372780, #msg-13209941, #msg-15535360).

In my opinion, the plasma AT products in the U.S. will be DOAA (Dead On ATryn’s Arrival) unless they are sold at a very substantial price discount to ATryn. But this will lessen the incentive of the manufacturers (Talecris and Grifols) to produce and promote their plasma AT products, and it will likely render these products all but irrelevant as ATryn competition.