The two companies hope to obtain approval for the clinical treatment of patients severely ill with COVID-19. The initial focus of the collaboration will be in Italy, Israel, and the U.S., with plans to subsequently expand development and distribution efforts to additional markets.
Kedrion will provide plasma collected at its KedPlasma centers from donors in both Europe and the U.S. who have recovered from the novel coronavirus. KedPlasma USA has received clearance from the U.S. Food and Drug Administration (FDA) and has begun to collect COVID-19 convalescent plasma from three centers, two of which are the greater Atlanta, GA area, and one facility in Mobile, AL. The company plans to expand its collection efforts to Europe, Australia, and South Korea.
Concurrently, Kamada will handle product development, manufacturing, clinical development, and regulatory submissions. The company also will distribute the SARS-CoV-2 products, while marketing rights in China will be shared by both companies.
Kedrion is in contact with health authorities in Italy, the home of its headquarters, while Kamada is in touch with the Israeli authorities where it is based. The companies also plan to connect with the FDA and the European Medicine Agency to seek an accelerated regulatory path to bring the anti-SARS-CoV-2 products to market.
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