Biotest AG
Biotest AG: Recombinant clotting factor VIII with the name Vihuma(R) approved
DGAP-News: Biotest AG / Key word(s): Regulatory Approval / PRESS RELEASE Recombinant clotting factor VIII with the name Vihuma(R) approved – Market launch in Germany end of April 2017 – Vihuma(R) is a 4th generation recombinant human factor VIII preparation from a human cell line – Vihuma(R) is an optimal portfolio supplement for Biotest
Dreieich, 1 March 2017. Today, the European Commission (EC) has approved the first, 4th generation human factor VIII preparation manufactured by Octapharma AG under the name Vihuma(R). Biotest AG will distribute Vihuma(R) in Germany from the end of April 2017. The approval in Switzerland has already been applied for and Biotest expects to start marketing Vihuma(R) in Switzerland in the fourth quarter. Vihuma(R) is produced from a human cell line and thereby recreates a natural preparation similar to Biotest’s Haemoctin(R), which is derived from human plasma. In contrast to conventional recombinant factor VIII preparations made with the aid of hamster cells, Vihuma(R) contains natural human structures. The similarity of Vihuma(R) to human Factor VIII is reflected in the name: “human”. Vihuma(R) is indicated for the treatment and prevention of bleeding episodes in children and adults with haemophilia A (congenital factor VIII deficiency). It is a high-quality alternative for patients in favor of a recombinant product to the recombinant factor VIII preparations available to date. In studies in previously treated patients, the 4th generation recombinant clotting factor has proved to be safe, effective and well tolerated. “With a recombinant factor VIII preparation from a human cell line, which has many of the advantages of a natural plasma clotting factor, we are continuing our strategy of using particularly well tolerated preparations,” states Dr Thomas Becker, Senior Director Haematology of Biotest AG. “We can now offer an alternative to patients who, together with their doctor, deliberately opt for a recombinant factor VIII preparation.” About recombinant factor VIII About Biotest IR contact Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201 Disclaimer
01.03.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |
Language: | English |
Company: | Biotest AG |
Landsteinerstraße 5 | |
63303 Dreieich | |
Germany | |
Phone: | 0 61 03 – 8 01-0 |
Fax: | 0 61 03 – 8 01-150 |
E-mail: | investor_relations@biotest.de |
Internet: | http://www.biotest.de |
ISIN: | DE0005227235, DE0005227201 |
WKN: | 522723, 522720 |
Indices: | SDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
End of News | DGAP News Service |