The two companies, each known for its cutting-edge biopharma technology capabilities, hope to obtain approval for the clinical treatment of severely ill COVID-19 patients. The initial primary 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.
Under the newly announced agreement Kedrion will provide plasma collected at its KEDPLASMA centers from donors in both Europe and the U.S. who have recovered from the virus.
KEDPLASMA USA, with the approval of the Food and Drug Administration (FDA), has already begun collecting COVID-19 convalescent plasma in three collection centers, two in the Atlanta, Georgia metroplex and one in Mobile, Alabama.
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. Kamada will distribute in all other territories, while marketing rights for the product in China will be shared by both companies.
Paolo Marcucci, Chairman and CEO of Kedrion, said: "Our top priority is getting this therapy to patients as quickly as possible, while of course demonstrating adequate safety and efficacy."
"We are excited to once again collaborate with Kamada, our partner for KEDRAB® [Rabies Immune Globulin (Human)]. Based on our collective expertise in plasma-derived protein therapeutics, Kedrion and Kamada are uniquely positioned to develop, manufacture and supply, in a relatively short period of time, this Anti-SARS-CoV-2 Immunoglobulin treatment," Marcucci explained.
The Kedrion CEO said the company is already in contact with the Italian health authorities while Kamada is in touch with the Israeli authorities. The companies are also planning to contact the U.S. Food and Drug Administration and the European Medicine Agency in order to seek an accelerated regulatory path.
Amir London, CEO of Kamada Ltd. said: "Our successful collaboration with Kedrion around our joint KEDRAB program is indicative of the unique capabilities of both companies, and we look forward to another successful partnership leveraging our strong working relationship and the core strengths of both companies."
Both Kamada and Kedrion pride themselves on being cautious and transparent, so they were careful to note that while they have high hopes for the new product "there can be no assurance that the planned development and manufacturing of an Anti-SARs-COV-2 product will be available in a timely manner and result in a safe, effective and approvable therapy for COVID-19."
Kedrion is the world's fifth biggest plasma company and is described by analysts as being both nimble and agile, meaning that its efforts to create an effective therapy for COVID-19 patients may move quite rapidly. The new partnership between the Italian and Israeli biotech companies could therefore become one of the first that is able to make this product available to patients in need.
Alessandro Gringeri, Chief Medical and R&D Officer of Kedrion Biopharma, explained that "in layman's terms what we will do is to first collect plasma from patients who have recovered from COVID-19, which include antibodies to the novel Coronavirus. We will then develop a pharmaceutical product which contains a defined dosage of these antibodies that can be administrated through either intravenous or intramuscular means, to patients who are suffering from COVID-19. We hope that the product may also be used in future as pre-emptive treatment for health care workers, to provide temporary passive immunization."
SOURCE Kedrion Biopharma
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