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Biotest shows excellent efficacy and tolerability of Haemoctin^(R) SDH in long-term study of patients with haemophilia A

- Clinical data of the worldwide longest surveillance study on198 patients representing all age groups (0-88 years) published

- Patients benefit more from prophylactic than from on-demand therapy

- Previously untreated haemophilia A patients scarcely develop antibodies against the product (low inhibitor formation)

Dreieich, 29 October 2019. Haemoctin^(R) SDH is a von Willebrand factor containing coagulation factor VIII preparation obtained from blood plasma from qualified voluntary donors. It is used for the treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency (Haemophilia A).

Within this surveillance study, 198 patients representing all age groups (0-88 years) were treated with Haemoctin^(R) SDH in Germany and Hungary. 160 patients had severe and 38 non-severe haemophilia A. Data were obtained during prophylactic or on-demand treatment over 18 years (overall 1,418 patient years; mean >7 years treatment time per patient) and analysed.^[1]

The annual bleeding rate was considerably lower for patients treated prophylactically (median 3.1) than for patients treated only on demand with Haemoctin^(R) SDH (median 21.9).

The development of factor VIII inhibitors is of particular importance associated with the therapeutic use of factor VIII. Factor VIII inhibitors are antibodies developed by the body of the patient against the used preparation. The activity of the factor VIII is neutralised by the antibodies, rendering the product ineffective. Factor VIII inhibitors were diagnosed in 13% of previously untreated patients with severe haemophilia A. Usually up to approximately 30% of patients with severe haemophilia A develop factor VIII inhibitors.

During this long-term study, no unexpected adverse effect on the general health of the patients was detected. These data prove the excellent efficacy and tolerability of Haemoctin^(R) SDH.

About Haemoctin^(R) SDH
Haemoctin^(R) SDH is a von Willebrand factor containing coagulation factor VIII preparation obtained from blood plasma from qualified voluntary donors. It is manufactured from a pool of up to 20,000 plasma donations using state-of-the-art concentration and purification techniques. The injection solution consisting of powder and solvent has been successfully used for more than 25 years for the treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency (Haemophilia A) and is appreciated for its good tolerability and low immunogenicity. Haemoctin^(R) SDH is storable for two years at room temperature and available in three different strengths. Dosage and duration of treatment with Haemoctin^(R) SDH depend on the indication and the severity of the disease.

About Haemophilia
As a lifelong inherited bleeding disorder, haemophilia affects about 1 in 10,000 people worldwide. Haemophilia is one of a number of such disorders that prevent blood from clotting properly. 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. Therefore, intravenously administered therapeutic factor VIII is often recognised as a foreign protein (antigen) by the patient's immune system. As a consequence up to 30% of patients with severe haemophilia develop antibodies against the therapeutic factor VIII. These antibodies are called inhibitors because they reduce or eliminate the therapeutic effect of factor VIII. Most inhibitors develop during early childhood and compromise the ability to effectively prevent or manage haemorrhages, resulting in a greater rate of disability, morbidity, complications and costs of therapy. The formation of inhibitors is the most serious complication of today's haemophilia treatment. Avoiding the risk of inhibitor development would be the most effective prerequisite for a continuous therapy enabling haemophilia patients to live an almost normal life without irreversible joint damage. 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 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: investor_relations@biotest.de

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
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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.^[1] https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-1698810