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Biotest AG: Biotest receives approval for double concentrated Haemoctin(R) SDH for improved haemophilia A treatment in Europe

DGAP-News: Biotest AG / Key word(s): Regulatory Approval

12.03.2019 / 07:00
The issuer is solely responsible for the content of this announcement.


Biotest receives approval for double concentrated Haemoctin(R) SDH for improved haemophilia A treatment in Europe

- Increased patient convenience: Volume reduction of the factor VIII concentrate Haemoctin(R) SDH with unchanged content of active ingredient

- Biotest strengthens its position in the haemophilia market

- Market launch in May 2019

Dreieich, 12 March 2019. Biotest receives approval in 13 European countries for the reduced solvent volume by half for the factor VIII concentrate Haemoctin(R) SDH.

Intravenous injections are periodically necessary for the treatment of patients with haemophilia A. The recurring injections needed for the maintenance of protective factor VIII levels are a major challenge, especially for very young patients and those with difficult vein conditions.

Therefore, Biotest reduced the volume for injection of Haemoctin(R) SDH by half. The reduced volume increases patient convenience as the injection duration is reduced and the veins are exposed to less stress. Quality of life is increased, especially for small children and patients that demand higher quantities of factor VIII.

Haemoctin(R) SDH is approved in 13 European countries. In the first step, the volume reduction from 10 to 5 ml was implemented for Haemoctin(R) SDH und 1000. In the second step, the volume reduction of Haemoctin(R) SDH 250 will follow. The approval for the introduction of the reduced volume was already granted for all European countries in which Haemoctin(R) SDH is approved. The national approvals are expected within 2019. Launch in Germany is planned for May 2019.

The successful improvement of Haemoctin(R) SDH supports the role of Biotest as leading provider of plasmatic factor concentrates for Haemophilia treatment.

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 many 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 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 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. In addition, Biotest develops monoclonal antibodies in certain cancer indications and in systemic lupus erythematodes, an autoimmune disease, which are produced by recombinant technologies. Biotest has more than 1,700 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

PR contact
Dirk Neumüller
Phone: +49-6103-801-269

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

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

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.

12.03.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange

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Last Updated: 12-Mar-2019