Kamada and Kedrion Biopharma have agreed 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 plasma-focused biopharma firms said on Wednesday.
The IgG product will be developed and manufactured using Kamada’s proprietary IgG platform technology.
Under the terms of the agreement, Kamada will be responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions.
Kedrion will provide plasma, collected at its KEDPLASMA centres, from donors who have recovered from the virus. Upon regulatory approval, it will be responsible for commercialization in the US, Europe, Australia, and South Korea.
Kamada will distribute the treatment in all territories outside of those Kedrion is responsible for and marketing rights for the product in China will be shared by both firms.
The collaboration will initially focus on providing the treatment to patients in Italy, Israel and the US through various clinical programmes, while expanding development and commercialization efforts to additional markets, the firms said.
“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. “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.”
Kamada’s Chief Executive Officer, Amir London, said his company intends to begin clinical manufacturing shortly.
“I am confident 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,” he added.
The partners have an existing strategic supply and distribution agreement for KEDRAB, a plasma-derived FDA-approved human rabies immune globulin that was launched in the US in April 2018.