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Pentaglobin^(R) showed a significant survival benefit in severe infections caused by multidrug resistant bacteria

- Additional therapy with Pentaglobin^(R) significantly reduced the relative mortality risk by 33% in patients with confirmed resistance to antibiotics

- Greatest relative survival benefit of 39% was seen in subgroup with infections by extensively drug resistant (XDR) bacteria, which are resistant to all but one antimicrobial agent

Dreieich, 23 May 2016. Severe bacterial infections are a major burden for health care systems around the globe. These infections are mainly treated with antibiotics. Once bacteria develop resistance to several antibiotics (multi drug resistance - MDR), the infections they cause are more dangerous and become much harder to treat and can even be life threatening.

Antibiotic resistance to a growing number of bacteria which cause infections is rapidly becoming one of the biggest threats to healthcare today. They lead not only to longer hospital stays and higher medical costs, but also to increased mortality. According to a recent WHO Review on Antimicrobial Resistance, infections caused by antibiotic resistant bacteria will be the leading cause of death by 2050 (1) .

The situation is particularly alarming for infections caused by so called gram negative bacteria, where observed resistance to antibiotic agents is high and continues to increase in many countries throughout the world. The increasing trend in resistance rates is particularly worrying in south and south-eastern Europe.

In Greece, common MDR gram negative species of Acinetobacter baumannii, Klebsiella pneumoniae and Pseudomonas aeruginosa are a well known cause of hospital acquired severe infections. Carbapenems are a class of antibiotics often used as the last line treatment for these MDR bacteria, however, resistance rates to carbapenems are greater than 65% limiting their treatment benefit.

Pentaglobin^(R) has shown to improve survival in patients with severe sepsis and septic shock in other clinical trials (2) . Now it was shown that patients with confirmed MDR infections treated with Pentaglobin^(R) had a significantly reduced risk of mortality compared to a control group treated with standard antibiotic therapy only. This retrospective analysis  (3) was conducted by The Hellenic Sepsis Study Group (HSSG).

All cause 28-day mortality was 58 out of 100 patients in the control group compared to 39 out of 100 patients in the Pentaglobin^(R) group. The relative reduction in mortality amounts to 33%. This difference was statistically significant.

65 of the Pentaglobin^(R) treated patients and 62 of the control group had confirmed infections caused by extreme drug resistant (XDR) gram-negative bacteria. 25 of the Pentaglobin^(R) treated XDR patients died (38.5%) compared to 39 patients (62.9%) in the comparator group. The relative reduction in mortality amounts to 39%, which was even more pronounced than in the overall group.

"The results of these analyses are extremely encouraging and provide promising support for the use of polyclonal IgM enriched immunoglobulin preparations as adjunctive antimicrobial treatment for the management of severe infections caused by MDR gram negative bacteria." said Professor Evangelos Giamarellos-Bourboulis of the National and Kapodistrian University of Athens Medical School."These pathogens progressively emerge in critically ill patients causing infections with reported mortality even exceeding 50%."

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

(1) http://amr-review.org/
(2) DOI 10.1007/s00134-014-3474-6
(3) http://dx.doi.org/10.1016/j.cmi.2016.01.021
 

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 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 cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,300 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

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Dr. Monika Buttkereit
phone: +49-6103-801-4406
email: investor_relations@biotest.de

PR contact
Dirk Neumüller
phone: +49-6103-801-269
email: pr@biotest.de

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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.