Grifols’ Biotest Receives FDA Approval for Innovative Immunoglobulin

Grifols recently announced Biotest, a Grifols Group company, has received approval from the US FDA for Yimmugo, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).

Yimmugo, developed by Biotest, adds to Grifols’ strong franchise of industry-leading intravenous and subcutaneous Ig treatments at a time of growing demand for plasma-derived medicines to treat immunodeficiencies, in which a part of the body’s immune system is missing or does not function properly, and other medical conditions.

The first US-approved medicine in Biotest’s portfolio, Yimmugo is produced using a state-of-the-art process at Biotest’s new FDA-certified Next Level production facility in Dreieich, Germany, which is already approved for production and marketing in Europe.

The launch of Yimmugo in the US in the second part of 2024 follows its successful introduction in Europe at the end of 2022 and is poised to add to Grifols’ future revenue growth and profitability.

Yimmugo is the first of a threesome of Biotest plasma proteins on the horizon destined for markets including the US. The other two, both in late-stage development, are a fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency – it would be the first FC approved for this indication in the US – and trimodulin, a polyvalent Ig to treat community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).

“The addition of Biotest’s Yimmugo to our strong portfolio of intravenous and subcutaneous immunoglobulins provides another innovative treatment option for patients with primary immunodeficiencies who rely on these essential medicines in their daily lives,” said Roland Wandeler, President Grifols Biopharma Business Unit.

The strategic acquisition of Biotest and the integration of its specialized resources has significantly accelerated Grifols innovation, deepened its product pipeline and furthered its industry leadership.

Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources.

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries.

Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases.

A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China.

As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership.

The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information, visit www.grifols.com.