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Biotest confirms good tolerability and efficacy of Intratect^(R) in primary and secondary immunodeficiencies in an observational study

- Proven reduction of infections in patients with secondary antibody deficiency

- Enhanced quality of life during treatment

- Good tolerability allows reduction of pre-medication

Dreieich, 22 April 2021. Intratect^(R) is a human intravenous immunoglobulin that is manufactured and marketed by Biotest in two concentrations (50 g/l and 100 g/l).

Patient data were collected in Germany in a large observational study focusing on patients with acquired antibody deficiency, e.g., due to chemotherapy. Up to the time of the interim analysis, 488 patients had been included. The age range was 16-91 years with a treatment duration of up to 2,225 days. The indications for immunoglobulin therapy were primary (32%) and secondary (61%) immunodeficiency, immune thrombocytopenia (4%) and other diseases (3%).^[1]

The attending physicians reported very good efficacy and satisfaction for over 92% of the patients. Patient satisfaction and quality of life increased over time during treatment with Intratect.

In clinical practice, it was noticeable that the immunoglobulin levels were increased in most patients (> 4 g/l) despite a relatively low dose of immunoglobulin (median 0.2 g/kg). Also, a considerable percentage of patients with a secondary immunodeficiency experienced an infection because they had been given a lower dosage than recommended in the guidelines. Dosage according to the guidelines presumably prevents further infections. Prior to the first administration of immunoglobulin in the study, 32% of the patients received pre-medication; after one year of Intratect treatment, this percentage was reduced by half to 16%.

The study thus underlines the good tolerability and efficacy of Intratect^(R), leading to an improvement in the patients' quality of life.

About Intratect^(R)
Intratect^(R) is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG). The ready-to-use solution is suitable for replacement therapy in primary and secondary antibody deficiency syndrome as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Dosage and duration of treatment depend on the indication and the severity of the 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 1,900 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

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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] Bauhofer et al. 2021, Int J Clin Pharmacol Ther, DOI: 10.5414/CP203952