Biotest AG
Biotest AG: First patient treated in the next clinical phase III study of IgG Next Generation in the indication Primary Immune Thrombocytopenia (ITP)
DGAP-News: Biotest AG / Key word(s): Research Update / PRESS RELEASE First patient treated in the next clinical phase III study of IgG Next Generation in the indication Primary Immune Thrombocytopenia (ITP) – Study no. 992 is the second pivotal phase III study in the clinical program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G – Study design was agreed with European regulatory authorities and results will serve as basis for European approval – Clinical data from Primary Immunodeficiencies (PID) and ITP will automatically lead to the approval of additional indications in Europe
The study is planned to include approximately 40 patients and will be conducted in a total of 18 study sites in Germany, Hungary, Spain, Bulgaria, Czech Republic and Serbia. According to the European Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG), there are two key studies required for the licensing of an IVIG in the European markets. Clinical data on efficacy and safety have to be generated in PID and primary immune thrombocytopenia (ITP) – to provide evidence as replacement therapy and to prove the immunomodulatory effect of immunoglobulines, respectively. Following approval, IgG Next Generation can be marketed additionally in the following established indications of IVIG: – Replacement therapy in secondary immunodeficiency disease e.g. – chronic lymphocytic leukaemia, – multiple myeloma and – after allogeneic haematopoietic stem cell transplantation – Immunomodulatory therapy in – Guillain Barré Syndrome (GBS) and – Kawasaki disease IgG Next Generation is manufactured using a brand new production process and will serve as the master product or the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, which uses state of the art technologies, represents Biotest’s latest commitment to the global immunoglobulin markets. In 2014 the market volume of immunoglobulins for the indication PID in US and EU amounted to approximately EUR 1.5 billion. The additional market volume of ITP and the supplementary indications in Europe amounted to approximately EUR 0.8 billion. About study no. 992 About Primary Immune Thrombocytopenia (ITP) About Biotest IR contact Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201 Disclaimer
25.01.2017 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 |
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