Kamada (KMDA)

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Kamada Announces Submission of Application to the U.S. FDA to Manufacture CYTOGAM® at the Company’s Facility in Israel

https://finance.yahoo.com/news/kamada-announces-submission-application-u-120000322.html

FDA Approval Currently Expected by Mid-2023

Sales of CYTOGAM® Highest Among Four IgG Products Acquired in November 2021, with Gross Margins Over 50%

Ability to Manufacture CYTOGAM at Kamada’s Facility to Positively Impact Plant Utilization and Efficiency

REHOVOT, Israel and HOBOKEN, N.J. , Jan. 04, 2023 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today 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%.

“The submission of this application to the U.S. FDA to manufacture CYTOGAM represents an important operational milestone for our company," said Amir London, Kamada’s Chief Executive Officer. “Importantly, our business leveraged the significant benefits of the acquired portfolio of four FDA-approved IgGs throughout 2022, and we expect additional growth from these important products in 2023 and beyond. We plan to initiate commercial manufacturing of CYTOGAM at our Israeli facility in the second half of this year upon receipt of FDA approval, which will positively impact the facility’s utilization and efficiency.”

Kamada’s currently available inventory of CYTOGAM is sufficient to meet market demand until the currently anticipated FDA approval timing of mid-2023.