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PIPELINE OVERVIEW

Kamada is focusing on development of biopharmaceutical products. These include its intravenous (IV) and inhaled (IH) Alpha-1 Antitrypsin (AAT) protein and Rabies IgG.

Kamada is at the forefront of clinical research for additional therapeutic indications for Alpha 1 Antitrypsin (AAT).

Kamada is currently in advanced discussions with the U.S. Food and Drug Administration (FDA) in order to secure the approval of an Investigational New Drug (IND) application this year to conduct a U.S. Phase 3 pivotal study of inhaled AAT for the treatment of AATD that would begin in 2018.  Kamada intends to utilize the data to be obtained from that pivotal study to resubmit the MAA to the EMA (In June 22, the company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) with the European Medicines Agency (EMA).  Following extensive discussions with the EMA during recent months, Kamada concluded that the EMA does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial).

Kamada is also dedicated to the research of AAT and its potential therapeutic characteristics for novel indications. The company has a late-stage AAT product candidates in development, including a designated intravenous formulations for GVHD, Type-1 Diabetes and Lung Transplantation.

For its Rabies Immunoglobulin product- KamRAB, Kamada has a strategic agreement with Kedrion for clinical development and marketing in the US.