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
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
12.03.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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