PRESS RELEASE

Biotest presented promising data on next generation recombinant Factor VIII at ISTH 2020

• Biotest unveiled new data about its novel recombinant Factor VIII molecules
• High bioavailability of 50% after subcutaneous (sc.) injection
• Substantially decreased dosing frequency expected due to 4-fold half-life extension in animal models
• Low immunogenicity and reduced risk of inhibitor development based on specific design expected
• Biotest explores partnering options to accelerate the development program

Dreieich, 21 July 2020. Biotest unveiled functional data from its new Factor VIII compounds at the ISTH 2020 congress (International Society on Thrombosis and Haemostasis). The content of the oral presentation and three scientific posters on its innovative compounds HAT (Haemophilia A Therapeutic) and HAT RI (Haemophilia A Therapeutic Reduced Immunogenicity) is available at Biotests homepage:
https://www.biotest.com/de/en/r_d/our_research_focus/haematology.cfm

HAT and HAT RI address the three major challenges of current Factor VIII products for haemophilia A therapy, which are the short Factor VIII half-life, the intravenous application route and the high risk for inhibitor development.

The molecules demonstrate a great potential for subcutaneous administration, evidenced by a high bioavailability of 50% observed in the "Göttingen minipig model".

Results from further animal models support a 4-fold extension of the half-life in blood circulation while maintaining the wild-type characteristics of activated Factor VIII with full in vivo functionality. Thus, a substantially decreased administration frequency can be expected.

The specific design of HAT and HAT RI shall confer lowest immunogenicity and reduced risk of inhibitor development, which is further enhanced by specific de-immunizing modifications in the HAT RI variant.

Biotest is currently looking for a partner in order to accelerate further development.

About HAT
HAT and HAT RI (Haemophilia A Therapeutic and Haemophilia A Therapeutic Reduced Immunogenicity) are in preclinical development for the treatment of haemophilia A. HAT and HAT RI are characterized by a substantial half-life extension of Factor VIII and the potential for intravenous and subcutaneous administration. These benefits are based on the fusion of special Factor VIII sequences with four albumin-binding peptides shielding the active substance from degradation. HAT RI additionally provides modifications within the Factor VIII section to further reduce the risk of inhibitor development, one of the major issues in haemophilia A therapy.

About Haemophilia
As a lifelong inherited bleeding disorder, haemophilia affects about 1 in 10,000 people worldwide. People with haemophilia experience prolonged internal bleeding that can result from a seemingly minor injury. Bleeding into joints and muscles causes severe pain and disability while bleeding into major organs, such as the brain, can cause death. Treating the bleeding episodes involves the prompt and proper use of clotting factor concentrates. Haemophilia A is caused by a deficiency of clotting factor VIII. A treatment option is the intravenously replacement of the missing factor. Therapy intervals may vary from patient to patient, but can require replacement several times a week, making haemophilia therapy quite burdensome. Up to 30% of patients with severe haemophilia develop antibodies (inhibitors) against the therapeutic factor VIII. The formation of inhibitors is the most serious complication of today's haemophilia treatment. For more information on haemophilia and FVIII, please visit the World Federation of Haemophilia website at https://www.wfh.org/en/home.

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 1,800 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: [email protected]

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]

Business development contact
Dr Dagmar Wolff
Mail: [email protected]

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, 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.