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PRESS RELEASE
Biotest receives approval in the European Union for the early use of Zutectra(R) after liver transplantation
- Application of the subcutaneous hepatitis B hyperimmunoglobulin Zutectra(R) already one week after liver transplantation approved
- Market position as a leading provider of hepatitis B hyperimmunoglobulins strengthened
Dreieich, 12 January 2016. The European Commission has granted marketing approval to Biotest for the early use of the hepatitis B immunoglobulin Zutectra(R) after liver transplantation. Before, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion for the modification of the indication in November 2015.
While Zutectra(R) could be administered 6 months after liver transplantation so far, the subcutaneous hepatitis B immunoglobulin can now be applied already one week after liver transplantation. The positive assessment is based on the clinical results of the Zutectra(R)-Early-Use-Study (ZEUS) demonstrating the effective use of Zutectra(R) in the early phase after liver transplantation.
The early administration of Zutectra(R) contributes significantly to a safe, more time efficient, less costly patient care and better convenience for the patient. This enables patients' training for self-medication already during hospitalisation. All in all, this allows a simplified and patient-friendly therapy.
The successful enhancement of Zutectra(R) supports the role of Biotest as leading provider of hepatitis B immunoglobulins.
About Zutectra(R)
Zutectra(R) was specifically developed by Biotest for the long-term treatment of patients after liver transplantation preventing hepatitis B virus re-infection. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients for self-medication. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option. The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra(R) in 2009. Zutectra(R) is currently marketed in the EU member states and major ROW markets.
About ZEUS
The international clinical phase III Zutectra Early Use Study (ZEUS) demonstrates effective and safe switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra(R), at the early phase after liver transplantation. Zutectra(R) was administered subcutaneously 8 - 18 days after transplantation preventing hepatitis B virus (HBV) re-infection in patients at risk for hepatitis B virus recurrence. No treatment failures and no clinical signs of a hepatitis B virus re-infection after six months of Zutectra(R) prophylaxis with excellent safety and tolerability data were observed.
About Biotest
Biotest AG 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 albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indication cancer of plasma cells and systemic lupus erythematosus (SLE), which are produced by recombinant technologies. Biotest has more than 2,200 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
email: investor_relations@biotest.de
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, Munich, Stuttgart
Disclaimer
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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