DGAP-News: Biotest AG
/ Key word(s): Research Update
05.09.2019 / 07:00
The issuer is solely responsible for the content of this announcement.
Biotest Achieves Important Clinical Milestone for IgG Next Generation
– Phase III study in Primary Immune Thrombocytopenia (ITP) completed, data evaluation in progress, promising results
– The study is one of two pivotal phase III studies in the clinical program for IgG Next Generation, a novel development of our polyvalent immunoglobulin G
– Clinical development in line with progress of new manufacturing facility Biotest Next Level
Dreieich, 5 September 2019. Biotest AG today announced the completion of study no. 992 – a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia (ITP). ITP is an autoimmune disease in which the immune system attacks and destroys the body’s own platelets, the cells that prevent bleeding in blood vessels and facilitate clotting. In the study 34 patients were treated. The evaluation of data is ongoing. First results confirm efficacy and safety expectations.
“We are very pleased to have completed the first key program milestone in the development plan for our new intravenous immunoglobulin. Final results are expected end of Q4/2019”, said Jörg Schüttrumpf, Head of Corporate R&D. “This product will be a new generation of our polyvalent immunoglobulin portfolio.”
Study no. 992 is one of two pivotal phase III studies in the clinical program for IgG Next Generation. After finalization of the second trial with IgG Next Generation in Primary Immunodeficiency (PID), both studies will be submitted together to the health authorities. Following approval, IgG Next Generation can be marketed in additional established indications of intravenous immunoglobulins, in particular replacement therapy in secondary immunodeficiency disease (e.g. chronic lymphocytic leukaemia, multiple myeloma, after allogeneic haematopoietic stem cell transplantation) and as immunomodulatory therapy in Guillain Barré Syndrome (GBS), Kawasaki disease, Multifocal motor neuropathy (MMN) and Chronic inflammatory demyelinating polyneuropathy (CIDP). The sales potential of immunoglobulins in immunomodulatory diseases in Europe is in the range of EUR1.3 billion, 7% thereof in ITP itself.
IgG Next Generation is manufactured using an innovative production process and will be the master product of 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.
About study no. 992
About Primary Immune Thrombocytopenia (ITP)
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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