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Biotest treats first shingles patient with Varitect^® CP in VARIZOSTA study

• High medical need in severe cases of herpes zoster (shingles) and resulting severe chronic nerve pain.
• Observational study with 160 patients to generate data to optimise treatment strategy for herpes zoster
• Proof of efficacy and safety of Varitect^® CP also in this indication

Dreieich, 5 September 2023. Biotest AG today announces that the first patient has been documented in the prospective, multicentre observational study VARIZOSTA conducted by Biotest. The study will evaluate the use of the herpes zoster virus-specific hyperimmunoglobulin Varitect^® CP (VZV-IgG) in complex herpes zoster, particularly in patients with a high risk constellation for severe disease progression.

The non-interventional study, in which 120 patients treated with VZV-IgG and 40 control patients are included, is being conducted at about 15 centres in Germany. The aim of the study is to expand the data on Varitect^® CP in routine use in patients with complex herpes zoster and to prove its efficacy and safety, also in comparison to standard therapy.

Herpes zoster is a viral disease that causes rashes and nerve pain in the affected areas of the skin. In severe cases, there can be severe chronic nerve pain (post-herpetic neuralgia) that lasts for months to years. Older and immunocompromised patients are particularly at risk for a severe case of the disease. In Germany, more than 400,000 people contract herpes zoster every year, about 60,000 of whom develop post-herpetic neuralgia.

"The results of the new study will provide valuable insights into the use and benefits of VZV IgG and make an important contribution to improving the care of patients with complex herpes zoster" emphasises Prof Dr Patrick Terheyden, Coordinating Investigator of the study.

About Varitect^® CP

The preparation is a specific hyperimmunoglobulin against the causative agent of herpes zoster disease, the varicella zoster virus (VZV), and can make an important contribution to control the viruses as well as the inflammatory processes on the nerve at an early stage and to avoid complications such as the development of post-herpetic neuralgia. Varitect^® CP contains a standardised amount of antibodies against the varicella zoster virus and is approved in the adjuvant therapy of herpes zoster in Germany and Switzerland. It is also approved in varicella post-exposure prophylaxis for various risk groups in Germany, Austria and Switzerland.

Varitect^® CP is the world's only approved non-antiviral therapy option for herpes zoster and, due to its complementary mechanism of action, offers the possibility of intensifying antiviral therapy in the early phase of herpes zoster disease.

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: ir@biotest.com

PR contact

Dirk Neumüller

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

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

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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.