Kamada Ltd. announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to manufacture CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) at its facility in Beit Kama, Israel. The application was submitted as a prior approval supplement (PAS) and FDA approval is currently expected by mid-2023. The anticipated FDA approval will mark the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring.

A similar application to the Canadian health authorities is expected to be submitted imminently. Kamada's CYTOGAM technology transfer supplement includes an upstream protein solution manufacturing step performed by Prothya Biosolutions in its plant in Belgium, under a contract manufacturing agreement between the parties. CYTOGAM is indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and heart, and is the sole FDA-approved immunoglobulin (IgG) product for this indication.

CYTOGAM is the highest selling of the four IgG products acquired from Saol Therapeutics in November 2021 and maintains gross margins of over 50%. Kamada's currently available inventory of CYTOGAM is sufficient to meet market demand until the currently anticipated FDA approval timing of mid-2023.