Over the past months, our lives have changed dramatically as a result of the Coronavirus (COVID-19) pandemic. COVID-19 is caused by the novel virus SARS-CoV-2. As new facts about the virus and the pandemic are revealed, the international scientific community, along with the pharmaceutical industry, are making tremendous efforts in order to combat the disease.
Since the outbreak of COVID-19, Kamada has been leveraging its unique human-plasma purification technology to develop an immune-globulin for Coronavirus Disease (COVID-19).
Kamada has extensive experience in the development, manufacturing and marketing of plasma-derived immunoglobulin therapies including Anti-Rabies, Anti-Rho(D) and Anti-snake venom. Kamada’s Anti-Rabies IgG product is FDA approved and is distributed in the US market through a collaboration agreement with Kedrion Biopharma. Kamada’s other IgG products are currently marketed in over 25 countries.
Hyperimmune therapy refers to the administration of specific antibodies against an infectious agent, to an unprotected individual, for the prevention or treatment of a given disease. Such antibodies are concentrated from plasma. The concept previously shown to be effective in the treatment of severe acute viral infections, such as rabies, hepatitis, CMV and others.
The role of antibodies is to bind antigens, such as viruses and bacteria, and trigger their neutralization and destruction as part of the immune response against pathogens.
This approach can be implemented utilizing Kamada’s established technology, allowing the development and manufacturing of specific plasma-derived immunoglobulin products in a relatively short period.
The development process starts with collecting plasma from patients who recover from COVID-19 (referred to as “convalescent plasma” and “convalescent patients”, respectively). The convalescent plasma is expected to contain specific antibodies against Coronavirus. The plasma is purified utilizing Kamada’s proprietary and approved purification technology, and the antibodies are concentrated to a specific dosage form.
Pending the availability of adequate quantities of convalescent plasma and the required regulatory path for treatment approval, access to treatment is expected to be relatively short.
Kamada announced completion of enrollment and initial interim results from its Phase 1/2 clinical trial in Israel of its plasma-derived Hyperimmune Immunoglobulin product as a potential treatment for Coronavirus disease (COVID-19).
Starting 2021, Kamada is supplying the Israeli Ministry of Health its Investigational Hyperimmune IgG Product. The initial quantity supplied would be sufficient for treating hundreds of hospitalized COVID-19 Israeli patients.
The execution of this supply agreement is an important milestone in the company’s development program, and represents the first contract globally for the supply of a plasma-derived IgG product for COVID-19.
Kamada also continue to promote the path for FDA’s acceptance of a clinical development program, together with its global partner Kedrion Biopharma. U.S.
Kamada and Kedrion Biopharma, a global leader in plasma collection and plasma-derived therapeutics, announced a global collaboration for the development, manufacturing and distribution of a human plasma-derived immune-globulin for Coronavirus. as a potential treatment for COVID-19 patients.
Joining forces with Kedrion is expected to speed up the development of the product and strengthen Kamada’s international reach. The initial focus of the collaboration will be to provide the product as treatment to patients in Israel, U.S and Italy through various clinical programs, while subsequently expanding development and commercialization efforts to additional markets.
Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional batches of the product.
This global collaboration expands the existing relationship between Kamada and Kedrion beyond KEDRAB®, a plasma-derived FDA-approved human rabies immunoglobulin that was launched successfully in the U.S. during 2018.
Patients who have recovered from COVID-19 are encouraged to check if they are eligible to donate plasma. Their convalescent plasma is expected to contain specific antibodies which bind to the novel Coronavirus, SARS-CoV-2, and assist in generation of the immune response against it.
The process of plasma donation is called Plasmapheresis. It is simple and takes less than an hour. It is usually done at a dedicated plasma collection facility. During the collection process the recovered patient’s (donor) blood is processed using an instrument that separates the plasma, which is the liquid containing the antibodies, from the white and red blood cells, which are returned to the donor in a closed loop system.
Kamada strives to serve patients worldwide, focusing on its strength to produce highly- purified specialty plasma therapeutics. We are proud to take part in the global effort to find an effective treatment for coronavirus patients.
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