PRESS RELEASE

Biotest receives approval for innovative immunoglobulin Yimmugo^® in the UK

• New approval enables future sales growth
• Important therapeutic option for paediatric and adult patients with congenital and acquired immunodeficiencies as well as for immunomodulation
• Manufactured in highly efficient Biotest Next Level production facility in Germany

Dreieich, 21 September 2023. Biotest AG announced today that its intravenous immunoglobulin Yimmugo^® (IgG Next Generation) has now also received approval in the United Kingdom for the treatment of patients with congenital and acquired immunodeficiencies and for immunomodulation, following approvals in Germany and Austria.

"We are delighted that this approval gives us the opportunity to launch our new immunoglobulin in another important European market," said Enrico D'Aiuto, Senior Vice President, Head of Global Sales and Marketing. "This will help us to meet the growing demand for immunoglobulin therapies, provide even more patients with our new immunoglobulin and thus contribute to improving their quality of life."

The new immunoglobulin is the first product to be manufactured using an innovative process in the new "Biotest Next Level" production facility at the Dreieich site. It has been investigated in extensive approval studies for safety, efficacy and tolerability. The UK market launch is possible with immediate effect.

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 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. 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 plasma proteins and biological drugs. 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 2,300 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).

IR contact

Dr Monika Buttkereit

Phone: +49-6103-801-4406
Mail: [email protected]

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: [email protected]

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, 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/ Hannover, München, 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.