Kamada Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved its application to manufacture CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) at the Company’s facility in Beit Kama, Israel. The FDA approval represents the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring.
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.
A similar technology transfer application was submitted to the Canadian health authorities in January 2023 and is currently under review.
CYTOGAM is indicated for the prophylaxis of cytomegalovirus disease (CMV) 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 by Kamada in November 2021, generating approximately $23 million in sales in 2022, and maintains gross margins of over 50%.
“The U.S. FDA approval of this application to manufacture CYTOGAM, which was granted within our expected timeline, following a successful on-site inspection by the FDA, represents a significant accomplishment for Kamada. This is the third product, in addition to GLASSIA and KEDRAB, to be approved by the FDA for manufacturing at our Israeli site,” said Amir London, Kamada’s Chief Executive Officer. “Our business continues to leverage the substantial benefits of the acquired portfolio of four FDA-approved IgGs, and we expect additional growth from these important products in 2023 and beyond. We intend to initiate commercial manufacturing of CYTOGAM at our Israeli facility shortly, which will positively impact the facility’s utilization and efficiency. Kamada’s continued investment in the manufacturing and distribution of CYTOGAM is representative of the Company’s commitment to ensuring the ongoing supply and availability of this important medicine to healthcare providers and solid organ transplant patients.”