Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against COVID-19

Barcelona, June 11, 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 the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin with specific antibodies using the plasma of people who have overcome the disease. It is the first specific drug developed to combat COVID-19.

Grifols is leading the production of this potential anti-COVID-19 passive immune therapy as 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. The agreement also encompasses the development of preclinical and clinical trials required to determine treatment efficacy. The company is also moving forward to establish collaborations in Europe.

Grifols’ anti-SARS-CoV-2 hyperimmune immunoglobulins are being produced in its Clayton (North Carolina, U.S.) facility, which has been specifically designed to process specialty immunoglobulins.

The first doses are expected to be available in July 2020 as part of a clinical trial.

Grifols leverages its broad expertise and experience in previous healthcare emergencies like the Ebola outbreak to become the first company to start production of an anti-SARS-CoV-2 hyperimmune immunoglobulin.

At the same time, Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin to stabilize or improve the condition of COVID-19 patients.

In this regard, the trial aims to assess the action of neutralizing antibodies (proteins that bind viruses and prevent them from infecting human cells), as well as determine the immunomodulatory potential (immune modulation response) of immunoglobulins as therapy to block the cytokine storm in patients with severe cases of COVID-19.
 

Immunoglobulins: plasma proteins with a broad therapeutic potential and complex action mechanisms that are difficult to replicate

Immunoglobulins are plasma proteins that act like antibodies as part of the body’s defense system, with complex and hard-to-replicate mechanisms of action.

Thanks to their broad scope of action - including their immunomodulatory effects - immunoglobulins have a vast and varied range of clinical applications, such as the prevention of infection in immunodeficient patients and autoimmune diseases, both neurological and in other organs.

Treatment with immunoglobulins is essential in the prevention of infections in the event of accidental exposure to infectious agents such as Hepatitis B or the Rabies virus. They are also essential in the prevention of infections in patients with primary immunodeficiencies (PID), which include more than 300 diseases, 150 of which stem from a congenital defect. These diseases are the result of a quantitative and/or functional alteration of the various mechanisms involved in the immune response.

Immunoglobulin has also been proven as a safe and effective treatment for a number of neurological diseases, including Guillain Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy, myasthenia gravis, and Lambert-Eaton syndrome, among others.

These highly complex diseases are difficult to treat without intravenous immunoglobulin due to limitations in reproducing all of their mechanisms of action, which are the result of the natural evolution of the human immune system.

With broad therapeutic potential, immunoglobulins are also used to treat secondary immunodeficiencies, which occur when a disease or therapeutic treatment decreases the immune cells’ ability to react against pathogens and form antibodies, requiring that part of the immune system to be replaced.

This type of immunodeficiency can also appear in autoimmune diseases like rheumatoid arthritis, lupus and multiple sclerosis as a consequence of the use of immunosuppressive drugs. Treatments for diseases such as cancer may also lead to weakened immune systems. Thus, research is currently underway to discover new immunotherapy and immunoglobulin strategies for cancer patients.

At present, there are more than 5,000 clinical trials¹ around the world to further explore the treatment potential of this plasma protein.

Grifols is the worldwide leader in the production and sale of immunoglobulins and remains firmly committed to addressing the current and future needs of patients in need of this plasma protein thanks to the generosity of its donors.

Strong growth forecast for immunoglobulins in 2019-2022

According to the Marketing Research Bureau (MRB), the immunoglobulin market will continue to grow annually by a high single digit in the 2019-2022 period.

Advancements in immunotherapies are expected to spark higher demand for immunoglobulins during this period. Therapies like CAR-T cells could create a growing need for these plasma proteins in the field of secondary immunodeficiencies.

¹Source: www.clinicaltrials.gov