GTC has entered into negotiations for the transition of the program for the commercialization and clinical development of ATryn® for Europe and the Middle East from LEO Pharma to LFB. This follows an internal strategic review and reprioritization by LEO. LEO has confirmed that there are no safety or efficacy issues with the ATryn® product either commercially or in the Phase II clinical study for the potential treatment of disseminated intravascular coagulation, or DIC, associated with severe sepsis.
LFB, currently a 20% shareholder in GTC, has expressed a significant interest in commercializing ATryn® in Europe and the Middle East for its existing indications. LFB is also interested in continuing the development of ATryn® in the ongoing Phase II DIC study and for other clinical indications. Further patients are not being recruited into the Phase II study until completion of the transition to LFB. LFB has additional strategic commercialization and development programs with GTC in recombinant plasma proteins, including factor VIIa, factor IX and alpha-1 antitrypsin, and also an anti-CD20 monoclonal antibody.