Biotest receives approval for Intratect(R) in France
- Approval in last major European immunoglobulin market in which Biotest has not yet had approval
- Biotest starts nationwide commercialisation for future sales growth of Intratect(R)
- Immunoglobulin market in France has sales volume of 550 million EUR
Dreieich, 30 November 2021 Biotest AG today announces the marketing authorisation in France for the human intravenous immunoglobulin preparation Intratect(R), which is manufactured and marketed by Biotest in two concentrations (50 g/l and 100 g/l). The regulatory process (Repeat Use Procedure) and the approval of Intratect(R) in France were completed in a very short time.
Intratect(R) is an important component of Biotest's portfolio with over 50 approvals worldwide. The broad spectrum of indications includes substitution therapy for primary and secondary immunodeficiency diseases as well as immunomodulation for primary immunothrombocytopenia, Guillain-Barré syndrome, Kawasaki syndrome, chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy.
Due to a shortage of human intravenous immunoglobulin preparations in France, Biotest has already been marketing Intratect(R) in both concentrations since spring 2021 on the basis of a national exemption. "We are very pleased that we can now further expand the marketing of Intratect(R) on the basis of a regular marketing authorisation in France" emphasises Henrik Oehme, Head of Region Middle East, Africa & France, "with the approval of Intratect(R), there is now another human intravenous immunoglobulin preparation in France, which helps to ensure a continuous supply of this vital preparation for patients."
The demand for immunoglobulin preparations in France is approximately 10 tonnes per year. "We thank the French authorities for their cooperation in partnership, which allows us to make our contribution to the supply of patients in France", says Dr Olivier Samama, Managing Director of Biotest France SAS.
Intratect(R) is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIG). The ready-to-use solution is suitable for replacement therapy in primary and secondary antibody deficiency syndrome as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Dosage and duration of treatment depend on the indication and the severity of the disease.
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 care 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. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
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.
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