Grifols, one of the world’s leading producers of plasma-derived medicines, has announced that Biotest, a Grifols Group company, forecasts approximately USD 1 billion in revenue from sales in the United States of its intravenous immunoglobulin (Ig) Yimmugo during the next seven years, following recent Food and Drug Administration (FDA) approval to treat primary immunodeficiencies (PID).
Yimmugo is the first Biotest medicine to be commercialised in the US from its new FDA-certified “Next Level” production facility in Germany, which is already approved for production and marketing in Europe, where Yimmugo has been commercialised since late 2022. It will launch in the US in the first quarter of 2025 and be distributed by Kedrion under a seven-year agreement with Biotest, part of an overarching Grifols Group channel strategy to ensure extensive reach and availability of its Ig therapeutics. Grifols Group and Kedrion have a longstanding collaborative relationship.
Grifols itself will focus on continuing the growth of its leading and well-established intravenous and subcutaneous Ig treatments. Now, with Yimmugo, the Group’s US portfolio will have an additional option to address the growing demand for Ig to treat immunodeficiencies, in which part of the body’s immune system is missing or does not function properly, and other medical conditions.
“Ensuring that patients receive the best possible care is at the core of our mission,” said Roland Wandeler, President Grifols Biopharma Business Unit. “Our distribution strategy will enable us to maximize the availability of Grifols' top-tier intravenous and subcutaneous immunoglobulins across the US, offering patients a comprehensive range of effective treatment options.”
Yimmugo, a key driver of Grifols Group’s US growth strategy, will be followed by other Group proteins in this market, including fibrinogen and trimodulin, both in late-stage development. Its fibrinogen concentrate would be the first to receive a US indication to treat acquired fibrinogen deficiency, while trimodulin is a polyvalent antibody composition for community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).
"With Yimmugo we are very excited to enter this important market for our industry and are committed to developing and delivering more therapies to patients in the US in the coming years," said Peter Janssen, CEO of Biotest AG. "I am confident that Yimmugo will be a commercial success in the U.S. and provide an additional meaningful treatment option to patients."
