CASTELVECCHIO PASCOLI, Italy, Aug. 25, 2020
CASTELVECCHIO PASCOLI, Italy, Aug. 25, 2020 /PRNewswire/ -- Two innovative bio-pharma companies specialized in plasma-derived therapeutics - Kedrion Biopharma of Italy and Kamada Ltd. of Israel - are continuing their work on the development, manufacturing and clinical distribution of a plasma-derived Anti-SARS-CoV-2 product.
The two companies, each known for their cutting-edge biopharma technology capabilities, hope to eventually obtain approval on both sides of the Atlantic for the clinical treatment of severely ill COVID-19 patients. Under the terms of the agreement, Kamada is responsible for product development, manufacturing, clinical development (with Kedrion's support) and regulatory submissions. Kedrion is responsible for collection and supply of plasma from convalescent COVID-19 patients and future distribution of the therapeutic product in the U.S., Europe, Australia and South Korea.
KEDPLASMA USA, with the approval of the Food and Drug Administration (FDA), has already begun collecting COVID-19 convalescent plasma in various collection centers in the United States.
The U.S. Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients. Pure plasma from convalescent patients that is transferred to those afflicted by the virus cannot be manufactured in millions of doses; its availability is limited by blood donations. The product being developed by Kamada Ltd. And Kedrion Biopharma instead, aims to miniaturize the dosages so it can be produced in large quantities.
Last month Kedrion announced that it had formed a research partnership with Columbia University Irving Medical Center to develop and test a new IgG therapy for COVID-19 which is being developed by Kedrion and Kamada Ltd, a leading Israeli bio-pharmaceutical company that specializes in plasma derived products.
Under the terms of the agreement, Kedrion will supply Columbia with convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the convalescent plasma against viral proteins to check the neutralizing power of the hyperimmune Immunoglobulins.
Dr. Steven Spitalnik, Medical Director of the Clinical Laboratories at Columbia University Irving Medical Center, said in July that he hopes that if the therapy eventually receives FDA approval it can be administered to his own frontline medical workers at risk for COVID-19 at Columbia University Irving Medical Center and elsewhere.