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Biotest AG: Biotest receives positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the early use of Zutectra(R) after liver transplantation


News: Biotest AG / Key word(s): Regulatory Admission

2015-11-23 / 12:00



/
PRESS RELEASE

Biotest receives positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the early use of Zutectra(R) after liver transplantation

- Market position as a leading provider of hepatitis B hyperimmunoglobulins strengthened

- Biotest expects European approval in February 2016

Dreieich, 23 November 2015. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the approval for the indication expansion of the subcutaneous hepatitis B immunoglobulin Zutectra(R).
Zutectra(R) was developed by Biotest especially for the permanent treatment of patients after liver transplantation as prophylaxis against re-infection with hepatitis B. Worldwide Zutectra(R) is the first subcutaneous hepatitis B immunoglobulin in a ready to use syringe. It is suitable for self-medication at home.
While currently Zutectra(R) can be administered 6 months after liver transplantation; following approval the subcutaneous hepatitis B immunoglobulin can be applied as early as 8 days after liver transplantation. This enables patients' training for self-medication already during hospitalisation. All in all this results in a less painful, more time-efficient and simplified therapeutic option for both the treating physician and the patient.

The positive assessment is based on the clinical results of the Zutectra-Early-Use-Study (ZEUS) demonstrating the effective use of Zutectra(R) in the early phase after liver transplantation, e.g. as early as 8 days after the transplantation.

In the next step, this positive opinion of the CHMP is referred to the European Commission, which is responsible for granting final expansion of the marketing authorisation for the entire EU. As a rule, the European Commission grants indication expansions after a formal review within a time frame of 75 days following a positive CHMP opinion.

The early administration of Zutectra(R) contributes concomitantly to a safe, more time efficient, less costly patient care and better convenience for the patient.
This 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 study 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.





2015-11-23 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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