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Pentaglobin^(R) showed encouraging results in the treatment of donor specific antibodies after lung transplantation

- In lung transplantation early new donor specific antibodies (DSA) are risk factors for mortality and graft rejection

- Pentaglobin showed very good efficacy in patients who showed early DSA development after lung transplantation

- Patients with early new DSA but treated with Pentaglobin^(R) have midterm survival and lung function comparable to patients not developing DSA at all

- Relative mortality rate reduction of over 70%

Dreieich, 14 January 2016. In lung transplantation early new donor specific antibodies (DSA) are risk factors for mortality, and acute and chronic graft rejection. About 20-30% of all lung transplantation patients develop DSA. Hence, DSA treatment seems to be justified albeit to date, no standard treatment is established in lung transplantation. In a recently published study conducted in Hannover Medical School, Germany, it was shown that patients treated with Pentaglobin^(R) (IgM / IgA enriched immunoglobulin) with early DSA development after lung transplantation had a significantly higher survival rate than patients treated with therapeutic plasma exchange.

In the Pentaglobin^(R) group (56 patients) the survival rate of 94% after one year was comparable to patients without DSA (180 patients) and much higher than in the historic therapeutic plasma exchange group (57 patients) with a survival rate of 79%. Already after one year the relative mortality rate was reduced more than 70%.

"The magnitude of the difference between the two treatment strategies was more pronounced than we expected. The mortality risk caused by DSA after lung transplantation was significantly reduced with IgM / IgA enriched immunoglobulin." stated Prof Dr Gregor Warnecke, principle investigator of the study.

Pentaglobin^(R) therapy yielded superior DSA clearance (92%), which persisted long term and was significantly better than that in therapeutic plasma exchange treated patients (64%). Additionally the Pentaglobin^(R) patients showed less infections requiring hospitalization and improved early freedom from bronchiolitis obliterans syndrome (inflammatory disease of the small airways, in which a scarring process leads to a progressive closure), major cause for graft failure and re-transplantation.

These encouraging results justify evaluating the potential of IgM / IgA enriched immunoglobulins in additional indications. Biotest has recently completed a phase II trial for the newly developed IgM / IgA enriched IgM Concentrate (BT-086) and is currently planning the further development in a phase III trial.

About Pentaglobin^(R)
Pentaglobin^(R) is the first and only IgM-enriched immunoglobulin preparation for intravenous use. Pentaglobin^(R) significantly increases the survival rate of patients with severe bacterial infections and acts against a broad spectrum of bacterial pathogens. Pentaglobin's^(R) mode of action, is both anti-bacterial by fast neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin^(R) is licensed in several countries, mainly for the treatment of severe bacterial infections in combination with antibiotics.

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
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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.