Biotest AG
Milestone for Biotest: US approval for innovative immunoglobulin Yimmugo

PRESS RELEASE

Milestone for Biotest: US approval for innovative immunoglobulin Yimmugo

• FDA approval secures significant future sales and earnings growth through entry into the world’s largest market
• Manufactured at Biotest’s state-of-the-art, FDA-certified “Next Level” facility in Germany

Dreieich, Germany, June 17, 2024. Biotest AG today announced that its intravenous immunoglobulin Yimmugo^® has been approved in the United States for the treatment of patients with primary immunodeficiencies (PID). At the same time, the site in Dreieich, Germany, has been certified by the FDA. Previously, Biotest had already received approval for production and marketing in European markets.

“With this approval, we aim to increase the availability of and access to immunoglobulin therapies worldwide, thereby improving patient care,” said Peter Janssen, CEO of Biotest AG. “We are very pleased that with Yimmugo^® we can bring a product from Germany to the American market for the first time in the history of Biotest.”

Yimmugo^® is the first drug approved in the U.S. to be manufactured using an innovative process in the new “Biotest Next Level” production facility. It was analyzed for safety, efficacy and tolerability in extensive pivotal studies.

The U.S. approval was preceded by an approval process with the U.S. Food and Drug Administration (FDA) in which Yimmugo^® and its manufacturing facility were successfully demonstrated to meet the FDA’s approval requirements within the first cycle and without delay. This is a great achievement for Biotest’s employees and partners, who have worked with great dedication on the development of the product and the realization of the modern production facility with state-of-the-art technology.

About Yimmugo^® (IgG Next Generation)

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 Europe for substitution therapy in primary antibody deficiency syndromes and secondary immune deficiency, as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Under the US License Biotest is authorized to manufacture Yimmugo^® for the treatment of primary humoral deficiency (PI) in patients 2 years of age or older. Yimmugo^® is the first approved product from the new Biotest Next Level production facility. The modern production process stands for highest product quality and an extremely responsible use of resources.

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

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IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.