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engaged in the development, production and marketing of drugs in the field of biopharmaceuticals, submitted an application to the American Food and Drug Administration (FDA) for the production of the product CYTOGAM at the company’s factory in Beit Kama. The application was submitted as a prior approval supplement (PAS) and FDA approval is now expected by mid-2023.
The expected FDA approval will be a successful end to the technology transfer process for CYTOGAM from the previous manufacturer – CSL Behring. A similar request to the Canadian Health Authority is expected to be submitted soon.
The transfer of CYTOGAM’s technology to Kamada includes a protein purification step performed by Prothya Biosolutions at its plant in Belgium, as part of an agreement for the supply of production services signed between the parties.
CYTOGAM is approved for the prevention of cytomegalovirus disease in connection with kidney, lung, liver, pancreas and heart transplantation, and is the only one approved by the FDA as an antibody preparation for this indication. CYTOGAM is the product with the highest sales among the four antibody preparations purchased by Kamada from Saol Therapeutics in November 2021 and achieves a gross profit margin of over 50%.
Amir London, CEO of Kamada: “The submission of this application to the FDA for the production of CYTOGAM by Kamada is an important operational milestone for the company. It is important to note that we have already leveraged the significant benefits of the acquired portfolio of four FDA-approved antibody preparations during the year 2022, and we expect further growth from these important products In 2023 and beyond. We plan to start commercial production of CYTOGAM at our plant in Israel in the second half of the year, after receiving FDA approval, a move that will have a positive effect on the plant’s utilization and efficiency.”
Current available inventory of CYTOGAM is sufficient to meet market demand until FDA approval now expected by mid-2023.
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