Kamada Ltd. and Kedrion Biopharma, two prominent bio-pharmaceutical companies specialized in plasma-derived protein therapeutics, announced a global collaboration for the development, manufacturing and distribution of a human plasma-derived Anti-SARS-CoV-2 (COVID-19) polyclonal immunoglobulin (IgG) product as a potential treatment for coronavirus patients. The announcement follows separate previous reports by each of the two entities in connection with initiation of development programs for such product. The plasma-derived Anti-SARS-CoV-2 IgG product will be developed and manufactured utilizing Kamada’s proprietary IgG platform technology.
Pursuant to the agreed terms, Kedrion will provide plasma, collected at its KEDPLASMA centers, from donors who have recovered from the virus and, upon receipt of regulatory approvals, will be responsible for commercialization of the product in the U.S., Europe, Australia, and South Korea. Kamada is responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories outside of those Kedrion is responsible for. Marketing rights for the product in China will be shared by the parties.
The initial primary focus of the collaboration will be to provide the product as treatment to patients in Italy, Israel and the U.S. through various clinical programs, while subsequently expanding development and commercialization efforts to additional markets.
“In light of the current global coronavirus outbreak, Kedrion and Kamada have quickly focused their efforts on developing and manufacturing a potentially safe and effective treatment,” said Paolo Marcucci, Chief Executive Officer of Kedrion. “We are excited to collaborate once again with Kamada, our partner for KEDRAB® [Rabies Immune Globulin (Human)]. Based on our collective expertise in plasma-derived protein therapeutics, we believe Kedrion and Kamada are uniquely positioned to develop, manufacture and supply, in a relatively short period of time, an Anti-SARS-CoV-2 IgG treatment. We believe we have an important opportunity to make a significant impact for patients in need during this pandemic.”
“As previously reported, we initiated the development of an Anti-SARS-CoV-2 polyclonal immunoglobulin and intend to begin clinical manufacturing of the product shortly. I believe that the collaboration with Kedrion, a global leader in plasma collection and plasma-derived therapeutics, will allow us to speed up the development of the product and strengthen our international reach,” said Amir London, Kamada’s Chief Executive Officer. “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.”
This global collaboration expands the existing relationship between Kamada and Kedrion beyond KEDRAB, a plasma-derived FDA-approved human rabies immune globulin that was launched in the U.S. market in April 2018, based on a separate strategic supply and distribution agreement between the two companies.
There can be no assurance that the planned development and manufacturing of an Anti-SARS-CoV-2 product will receive regulatory approval, be available in a timely manner and/or result in a safe, effective and approvable therapy for COVID-19.