Biotest's Zutectra(R) demonstrates improved quality of life in a study with liver transplant patients
- Zutectra(R) offers convenient home therapy option for high risk Hepatitis B induced liver transplant patients during COVID-19 pandemic
- Zutectra(R) is the only Hepatitis B immunoglobulin product worldwide for self-administration at home
- New data of a multicentre observational study reveal improved quality of life with Zutectra compared to other applications forms
- Zutectra demonstrated significant improvement in pain reduction and increased patient convenience
- Study results support positive commercial outlook
Dreieich, 8 June 2020. Home care therapy with Zutectra(R) is a valuable option for liver transplant (LT) patients, especially during the current COVID-19 pandemic. Patients are not required to visit the hospital and remain independent from contacts with medical professionals. This minimizes contacts and the risk of infection in these immunosuppressed patients, while keeping them on therapy to prevent Hepatitis B recurrence.
Zutectra(R) is the worldwide only subcutaneous (SC) Hepatitis B immunoglobulin (HBIG) product and was developed to provide a convenient option for outpatient therapy. The preference of SC over intramuscular (IM) and intravenous (IV) application forms was confirmed by a recently published study in the Journal "Health and Quality of Life Outcomes".
The multicentre, observational study was conducted in nine LT centres in Italy including 86 patients. Previously to inclusion into the study liver transplanted patients have been on IV or IM HBIG therapy for at least 6 month before switching to Zutectra(R). Two validated quality of life questionnaires evaluating different categories of technical aspects of therapy as well as mental and physical conditions have been used before and 6 months after switching to Zutectra(R).
Zutectra(R) demonstrated significant improvements in most of the tested domains, such as side effects, satisfaction with the HBIG therapy, pain, physical functioning, physical and emotional role limitations, and social functioning.
The authors concluded: "The striking improvement in treatment satisfaction further suggests that SC HBIG can represent the treatment of choice for most LT patients."
Biotest sees an opportunity to expand market share, through switching patients to the only subcutaneous HBIG in the current COVID-19 pandemic and beyond.
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 gives patients the opportunity of self-administration. 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 Hepatect(R) CP
Hepatect(R) CP is a hepatitis B virus (HBV)-specific hyperimmunoglobulin preparation. Approved in over 35 countries Hepatect(R) CP is one of the leading HBV immunoglobulin brands worldwide. It is indicated for the prevention of HBV re-infection after liver transplantation and for immunoprophylaxis of HBV infection. Prophylaxis of HBV infection may be required in case of accidental exposure in non-immunised subjects (e.g. needle stick injury), in haemodialysis patients, until vaccination has become effective, in the newborn of a hepatitis B virus carrier-mother, and in subjects who did not show an immune response after vaccination. Hepatect(R) CP is available as ready-to-use solution for intravenous administration.
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 care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate
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.
 Volpes et al., 2020, Switch from intravenous or intramuscular to subcutaneous hepatitis B immunoglobulin: effect on quality of life after liver transplantation, Health Qual Life Outcomes, 18: 99
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