Biotest AG: Biotest receives approval for new intravenous immunoglobulin Yimmugo® (IgG Next Generation)

EQS-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: Biotest receives approval for new intravenous immunoglobulin Yimmugo® (IgG Next Generation)
14.11.2022 / 09:30 CET/CEST
The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

Biotest receives approval for new intravenous immunoglobulin Yimmugo^® (IgG Next Generation)

• New innovative immunoglobulin expands Biotest's product portfolio
• First sales expected before end of this year in Germany as first country
• Efficacy and safety proven in clinical studies
• Further therapeutic option for patients with congenital and acquired immunodeficiencies and for immunomodulation
• First approval for new immunoglobulin from highly efficient Biotest Next Level production facility

Dreieich, 14 November 2022. Biotest AG announced today that the German competent authority, the Paul-Ehrlich-Institute, has approved the new intravenous immunoglobulin Yimmugo^® (IgG Next Generation) in Germany.

"Biotest is expanding its immunoglobulin product portfolio with an innovative new product. Yimmugo^® offers patients and physicians another important treatment option whose safety, efficacy and tolerability have been proven in the approval studies," emphasises Dr Jörg Schüttrumpf, Chief Scientific Officer of Biotest AG. "The market launch of Yimmugo^® in Germany will start before the end of this year."

Based on the successfully conducted clinical trials, the approval covers the following indications in adults, children and adolescents:

• Replacement therapy for patients with congenital (primary, PID) and acquired (secondary, SID) immunodeficiency
• Immunomodulation in Primary immune thrombocytopenia (ITP), Chronic inflammatory demyelinating polyneuropathy (CIDP), Multifocal motor neuropathy (MMN), Guillain-Barré syndrome (GBS) and Kawasaki’s disease.

Yimmugo^® is the first commercial preparation to be produced in an innovative manufacturing process in the new "Biotest Next Level" production facility at the Dreieich site. The new approval of Yimmugo^® thus represents an important milestone on the way to a broader portfolio, greater product availability as well as a more sustainable use of the valuable raw material plasma and Biotest's complete climate neutrality by 2035.

"Our future depends on being more sustainable. That is why we try to optimise the use of natural resources wherever we can," underlines Dirk Neumüller, Chief Sustainability Officer, summaring Biotest's vision.

The approval in Germany was preceded by the recently successfully completed decentralised procedure in Germany and Austria, which Biotest submitted in March 2022. The approval procedure was successfully completed in less than 7 months. Approval in Austria is also imminent. Further approvals in European and non-European countries are planned.

Biotest had already received approvals in recent months to use plasma intermediates from the new plant for the production of the approved products human albumin (Albiomin^®) and factor VIII (Haemoctin^®). With Fibrinogen and Trimodulin, two new plasma proteins, which are also to be produced in the new facility, are also in an advanced stage of development (phase III).

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 replacement 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’s disease. 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 2,100 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact

Dr Monika 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.

14.11.2022 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com