July 28, 2020
Grifols delivers first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials
- The therapy, which provides passive immunity and could be used for both prevention and treatment, will undergo clinical trials this summer to evaluate its safety and efficacy
- This is part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies
- In the past months Grifols has been collecting convalescent plasma in more than 245 Grifols U.S. donation centers from healthy recovered COVID-19 donors who have met the highest eligibility criteria
Barcelona, Spain, July 28, 2020 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people’s health and well-being, today announced it has delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials.
This medicine specifically targets SARS-CoV-2 by providing passive immunity to infected patients and boosting their immune system’s ability to fight the disease. The therapy, which could be used for both prevention and immediate treatment of COVID-19, will undergo clinical trials this summer to test its safety and efficacy.
The anti-SARS-CoV-2 hyperimmune globulin, which is derived from the blood plasma of healthy donors recovered from COVID-19, has the potential to be a highly specific, pure and safe medicine that delivers a high and consistent concentration of protective antibodies against the novel coronavirus.
As a medicine class, hyperimmune globulins have been increasingly used since the 1970s to prevent and treat common diseases including measles, rabies and tetanus. They are also a potential therapy option in response to future outbreaks of emerging viruses and other pathogens.
Since April, Grifols has moved quickly to collect COVID-19 convalescent plasma for its anti-SARS-CoV-2 hyperimmune globulin in more than 245 Grifols U.S. donation centers from donors who have met the highest eligibility criteria. Their plasma, rigorously tested and quality controlled, had high levels of anti-SARS-CoV-2 neutralizing antibodies.
The efforts form part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies.
Previous experiences, particularly that with Ebola, have enabled the company to react rapidly to the challenge. During the Ebola outbreak in Liberia in 2014, Grifols collected convalescent plasma and designed and activated a plant in Clayton, North Carolina, especially equipped and staffed with personnel specialized in the production of plasma-derived medicines for infectious diseases.
“Grifols is grateful to all the plasma donors who through their generosity are now helping to develop a medicine, a hyperimmune globulin, whose concentrated antibodies will potentially provide others with passive immunity to overcome the disease,” said Victor Grifols Deu, co-CEO of Grifols.
Added Grifols co-CEO Raimon Grifols Roura: “All of us at Grifols are proud to devote our time, talent and energies to fight this health crisis.”
In addition to clinical trials in the U.S., Grifols is working on a European clinical trial of a hyperimmune globulin using convalescent plasma collected in Europe.
Grifols is the worldwide leader in the production and distribution of immunoglobulins and hyperimmune globulins, and is firmly committed to its mission of addressing the current and future needs of patients in the world.