Press Detail

Biotest AG: Biotest proves effective protection from Hepatitis B virus reinfection after liver transplantation in 'ZEUS' study with subcutaneous hepatitis B immunoglobulin Zutectra (R)

Biotest AG / Key word(s): Research Update

2015-04-23 / 10:30

PRESS RELEASE

Biotest proves effective protection from Hepatitis B virus reinfection after liver transplantation in "ZEUS" study with subcutaneous hepatitis B immunoglobulin Zutectra

- The Zutectra-Early-Use-Study (ZEUS) demonstrates safe and effective switch from high dose intravenous hepatitis B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra^(R), at the earliest one week after liver transplantation

- No Hepatitis B virus reinfection after six months of Zutectra^(R) prophylaxis with excellent safety and tolerability data

- Data presented at the 50^th International Liver Congress 2015 in Vienna, Austria

- Zutectra^(R) dossier submitted to European Medicines Agency (EMA) for EU-Approval

Dreieich, April 23, 2015. Biotest presents today the efficacy and safety results from the Zutectra-Early-Use-Study (ZEUS) at the 50^th International Liver Congress 2015 in Vienna, Austria.

The international clinical phase III study was performed in 17 transplant centers in four of the Big-Five EU-Markets, Italy, Spain, France and United Kingdom. Zutectra^(R) was administered subcutaneously combined with hepatitis B Virus virostatic therapy '8 - 18' days after transplantation preventing hepatitis B Virus (HBV) re-infection in patients at risk for hepatitis B virus recurrence.

47 adult patients suffering from life-threatening terminal liver disease due to long-lasting chronic hepatitis B or HCC (hepatocellular carcinoma) completed the study. There were no treatment failures and no clinical signs of a hepatitis B virus reinfection were observed. There were no treatment related serious-adverse-events (SAE) and only one treatment related but non-serious adverse-event (AE), a mild and transient hematoma at the injection site.

With the Zutectra-Early-Use-Study Biotest successfully extends the medical application of Zutectra^(R) to allow the earliest conversion to subcutaneous administration. This contributes concomitantly to a safe, more time efficient, less costly patient care and better convenience for the patient.

Biotest submitted the dossier for "Zutectra-early-use" after liver transplantation to the EMA for EU-approval. The approval process is expected to be finalized in Q4 2015.

About Zutectra^(R):
Zutectra^(R) was specifically developed by Biotest for the long-term treatment of patients after liver transplantation. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it enables patients to 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.

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.

About Biotest

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 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 indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2.100 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,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347

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, München, Stuttgart

2015-04-23 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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Language:	English
Company:	Biotest AG
	Landsteinerstraße 5
	63303 Dreieich
	Germany
Phone:	0 61 03 - 8 01-0
Fax:	0 61 03 - 8 01-150
E-mail:	investor_relations@biotest.de
Internet:	http://www.biotest.de
ISIN:	DE0005227235, DE0005227201
WKN:	522723, 522720
Indices:	SDAX
Listed:	Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart


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