Kamada Ltd. announced the positive scientific advice response from the committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) focused on the company’s development program in Europe for Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (aGvHD) with lower gastrointestinal involvement. The response from the CHMP included important guidance related to the design of the Company’s planned Phase 2/3 European study and the regulatory pathway for approval based on conducting such a study. Kamada is in the process of reviewing the guidance received and, following discussions with the Company’s European Scientific Advisory Board, intends to submit a Clinical Trial Authorization (CTA) application to the EMA in 2017 in order to conduct the Phase 2/3 study. Importantly, the design of the Company’s U.S. Phase 2/3 clinical trial of G1-AAT IV in aGvHD, which was recently initiated and is being conducted in the U.S. in collaboration with Shire plc, supports the guidance received from the EMA. Kamada intends to conduct the European study in parallel with the U.S. study. Kamada holds all rights to its G1-AAT IV in Europe, and the product is currently available there to acute GvHD patients in need on a named-patient basis through an Early Access Program. G1-AAT IV previously received orphan drug designation from the U.S. Food and Drug Administration and the EMA for the treatment of GvHD.