Biotest receives Intratect(R) approval for additional indications in 22 European countries
- Additional fields of use in neurology (CIDP, MMN) and secondary immunodeficiencies (SID)
- 40% of the globally produced immunoglobulins are used in the treatment of these diseases
- Biotest plans to enter new markets
Dreieich, 24 January 2019. Biotest has received the extension of the approved indications of Intratect(R) for the neurological indications chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN), as well as an extension in the field of secondary immunodeficiencies (SID).
CIDP is globally the most important neurological indication in immunoglobulin therapy - approximately 25% of the world's standard immunoglobulins are administered to treat CIDP. To date, Intratect(R) has been used very successfully for the treatment of acute neurological disorders such as Guillian-Barré syndrome (GBS).
Another application field of Intratect(R) are the primary and secondary immunodeficiency diseases (PID, SID). Reasons for the development of SIDs include various cancers, side effects of immunosuppressive drugs or metabolic disorders. At least 15% of the world's immunoglobulin levels are prescribed in the area of secondary immunodeficiencies. The label extension eliminates previous limitations of Intratect(R) approval.
With the broader range of indications, Biotest plans to enter new markets to enable additional patients to receive immunoglobulin therapy with Intratect(R).
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare acquired disorder of the peripheral nervous system. It manifests as relapsing or chronic progressive proximal and distal muscle weakness and frequent sensory disturbances. It can occur at any age. The prevalence is given as 0.8 to 8.9 cases per 100,000 inhabitants. In people with an average age of about 40-50 years, the disease occurs more frequently. A cure of the CIDP is rather rare. Nowadays high remission and clinical stability can be obtained through high dose immunoglobulin therapy.
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 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. In addition, Biotest develops monoclonal antibodies in certain cancer indications and in systemic lupus erythematodes, an autoimmune disease, which are produced by recombinant technologies. Biotest has more than 1,600 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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