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GigaGen Signs $135 Million US Contract for Manufacturing and Testing

GigaGen will develop a recombinant polyclonal antibody therapy for botulinum neurotoxins and another biological threat. Grifols expects €930 million in U.S. revenues from Yimmugo, an immunoglobulin drug for primary immunodeficiencies, following its FDA approval. Biotest’s U.S. launch is planned for early 2025, supported by a seven-year distribution agreement with Kedrion.

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Grifols’ biotechnology subsidiary, GigaGen, has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the United States for up to $135.2 million over a period of six years for the manufacture of products in two programs and Phase I trials.

According to a statement from the company on Thursday, it must develop a recombinant polyclonal antibody therapy for botulinum neurotoxins (BoNT) and a “second biological threat of interest to the agency to be determined at a later date.”

GigaGen CEO Carter Keller said the company “aims to change the way infectious diseases are treated” and welcomed the collaboration with the U.S. government.

Grifols expected revenues of 930 million euros in July from the sale of Yimmugo in the United States

Biotest, also part of the Grifols group, forecast in July revenues of approximately one billion dollars (930.4 million euros) from sales in the United States of its intravenous immunoglobulin (Ig) Yimmugo over the next seven years, the blood derivatives company announced in a statement on Monday.

Grifols
Grifols’ subsidiary, GigaGen, has signed a contract with BARDA. Source

This forecast is part of the recent approval by the US Food and Drug Administration (FDA) of this drug to treat primary immunodeficiencies. The Catalan company recalls that Yimmugo is the first Biotest drug produced at the Next Level plant in Dreieich (Germany) to be marketed in the United States .

In this context, this plant has recently been certified by the FDA and already has approval for production and marketing in Europe, where Yimmugo has been sold since the end of 2022.

Yimmugo will be launched in the United States during the first quarter of 2025 and will be distributed by Kedrion thanks to a seven-year agreement with Biotest, which is part of the Grifols Group’s broad distribution strategy to ensure extensive reach and availability of its Ig therapies. He also recalled that the Grifols Group and Kedrion have a long-standing collaborative relationship.

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