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Biotest Aktiengesellschaft (0N70.L)

LSE - LSE Delayed price. Currency in EUR
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25.20-0.40 (-1.56%)
As of 8:04AM BST. Market open.
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Previous close25.60
Open25.20
Bid0.00 x 0
Ask0.00 x 0
Day's range25.20 - 25.20
52-week range25.20 - 25.20
Volume2
Avg. volumeN/A
Market cap1.04B
Beta (5Y monthly)0.71
PE ratio (TTM)N/A
EPS (TTM)-0.69
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
  • EQS Group

    Biotest AG: Biotest is one of the first plasma protein manufacturers to provide digital package leaflets for all products

    DGAP-News: Biotest AG / Key word(s): Miscellaneous 10.09.2020 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASEBiotest is one of the first plasma protein manufacturers to provide digital package leaflets for all products\- The latest Biotest package leaflets are always available online\- Simplified use for patients and medical professionals\- Quicker access to current safety-related information for users of Biotest products Dreieich, 10 September 2020. Biotest is now one of the first plasma protein manufacturers to provide digital package leaflets for all products in Germany. They can be accessed both online and via an app. Even if users do not have the pack and package leaflet at hand, they can still read important information about the medication at any time and from anywhere by clicking on the app or going online.This enables simplified use for patients and medical professionals and also ensures quicker access to current safety-related information for users of Biotest products.Package leaflets are important. They provide users with information about medications, in particular regarding their safe and correct use. "We at Biotest felt it was vital to be able to provide our users with up-to-date versions of our package leaflets," said Dr Claudia-Carolin Keil, Senior Director Labelling/ Corporate Regulatory Affairs. Up-to-date means that the texts are published accordingly as soon as they are approved by regulatory authorities - and this can be done much quicker than implementation in the packs for the market.To satisfy the highest possible safety requirements, Biotest has now become a partner in the German project "Gebrauchsinformation 4.0" ("GI 4.0" - "Package Leaflet 4.0"). The GI 4.0 project, which is provided by Rote Liste Service GmbH, is a Europe-wide, unique consortium involving industry, authorities, associations and patients. ROTE LISTE Service GmbH is a subsidiary of the Federal Association of the Pharmaceutical Industry (BPI) and the Association of Research-Based Pharmaceutical Companies (vfa), as well as being publisher of the media services ROTE LISTE(R), FachInfo-Service(R), PatientenInfo-Service and Gebrauchsinformation 4.0.The package leaflets can be accessed at https://www.gebrauchsinformation4-0.de/. The GI 4.0 project is Germany's way of implementing Europe's efforts to make electronic product information ("ePI") available. If this project is implemented by other countries or even at a European level, Biotest will also be able to publish digital package leaflets for this in an instant.Furthermore, all of our package leaflets for blind and partially sighted users are available in a correspondingly prepared and accessible format for our patients at https://www.patienteninfo-service.de/.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 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.IR contact Dr Monika Buttkereit Phone: +49-6103-801-4406 Mail: investor_relations@biotest.dePR contact Dirk Neumüller Phone: +49-6103-801-269 Mail: pr@biotest.com Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.comOrdinary 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, TradegateDisclaimer 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. * * *10.09.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de * * * 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 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1129381 End of News DGAP News Service

  • EQS Group

    Biotest AG: Biotest phase II study for the treatment of severe COVID-19 patients with trimodulin approved

    DGAP-News: Biotest AG / Key word(s): Study 03.09.2020 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASEBiotest phase II study for the treatment of severe COVID-19 patients with trimodulin approved * A clear reduction in mortality and in duration of ventilation support during intensive care stay is expected * Worldwide unique, innovative plasma protein preparation for treatment of COVID-19 patients * Expedited approval of trimodulin for COVID-19 intended Dreieich, 3 September 2020. Biotest announced today that the ESsCOVID (Escape from severe COVID-19) trial for treatment of COVID-19 patients with trimodulin was approved by the Competent Authority and the responsible Ethics Committee in Spain. In addition, the study has now also been submitted for approval in Russia and Brazil.In this multinational phase II clinical trial, approximately 160 adult patients with severe COVID-19 are planned to be enrolled. These are patients with pneumonia or acute respiratory distress syndrome (ARDS) admitted to hospital due to the severity of their disease. After confirmation of SARS-CoV-2 infection and presence of a strong inflammatory response, the patients will be treated either with trimodulin or with placebo as add-on therapy to standard of care.The clinical concept of this prospective, double-blind, placebo-controlled phase II trial, was developed according to the expectations of the European Medicines Agency (EMA) after a so-called "Rapid Scientific Advice". Biotest aims for an expedited approval of trimodulin to rapidly respond to the need for novel treatment options for patients with severe COVID-19.Biotest's development product trimodulin is a worldwide unique, innovative antibody preparation. Trimodulin treatment has already demonstrated promising results in a phase II clinical trial with 160 invasive mechanically ventilated patients suffering from severe community-acquired pneumonia (sCAP) with a strong inflammatory response (CIGMA trial).The similarity of the COVID-19 symptoms to the patients treated in the CIGMA trial, suggests a considerable potential for trimodulin in the treatment of SARS-CoV-2 induced pneumonia."We are very pleased about the agreement to our trial concept by the Spanish Competent Authority. With the approval of the trial we are now preparing the initiation of selected study centers to enable treatment of COVID-19 patients with trimodulin as fast as possible", said Dr. Thomas Häder, responsible Head of Clinical Strategy & Development at Biotest.About COVID-19 COVID-19 is a respiratory disease caused by the novel severe acute respiratory syndrome corona virus 2 variant (SARS-CoV-2). While most cases are mild or asymptomatic, COVID-19 patients may present at the hospital with typical signs of pneumonia requiring oxygen support. This disease stage is regularly accompanied by an excessive immune response and can lead to systemic inflammation reactions. Furthermore, patients may progress to critical disease with need for intensive care, including invasive mechanical ventilation. This clinical picture and course of the disease resembles that of sCAP caused by other pathogens.About trimodulin (IgM Concentrate) Biotest' development product trimodulin is an innovative immunoglobulin preparation, purified from human blood plasma. In comparison to standard IgG preparations (IVIG), trimodulin contains relevant amounts of IgM and IgA in addition to IgG. Trimodulin is currently in clinical development for the treatment of patients with severe community-acquired pneumonia (sCAP) and for patients with severe COVID-19. Research so far has shown that trimodulin could interfere with a number of mechanisms involved in pathological processes that would otherwise lead to respiratory failure, sepsis, multi-organ failure and finally to death of the patient. Due to the large variety of polyvalent antibodies present in trimodulin, the impaired immune system is supported in various ways. The antibodies bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case, the lung. In this way, trimodulin may prevent progression of disease, including the need for invasive mechanical ventilation and other intensive care procedures.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 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.IR contact Dr Monika Buttkereit Phone: +49-6103-801-4406 Mail: investor_relations@biotest.dePR contact Dirk Neumüller Phone: +49-6103-801-269 Mail: pr@biotest.com Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.comOrdinary 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, TradegateDisclaimer 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. * * *03.09.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de * * * 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 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1126847 End of News DGAP News Service

  • EQS Group

    Biotest AG: Biotest achieves another important clinical milestone for IgG Next Generation

    DGAP-News: Biotest AG / Key word(s): Study results 01.09.2020 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASEBiotest achieves another important clinical milestone for IgG Next Generation * Phase III study in Primary Immunodeficiency Disease (PID) successfully completed * IgG Next Generation meets all clinical endpoints * Results will serve as basis for worldwide approval Dreieich, 1 September 2020. Biotest AG today announced the completion of study no. 991 - a phase III study investigating IgG Next Generation as replacement therapy in patients diagnosed with primary immunodeficiency disease (PID), a group of disorders in which a part of the body's immune system is missing or does not function properly.In the study, 67 patients were treated, including 18 children. The last patient completed the study beginning of April 2020. Biotest is currently finalizing the clinical study report. Study no. 991 examined the efficacy and safety of IgG Next Generation. The study has met its primary and secondary endpoints in patients with PID and the treatment was well tolerated by all age groups. The treatment emergent adverse events observed in the study are in line with those known for other IVIGs with regard to both type, severity, and frequency. The overall benefit-risk profile of IgG Next Generation was favorable in all age groups assessed."We are very pleased to have successfully completed this milestone in the development plan for our new intravenous immunoglobulin and that the results with IgG Next Generation have met the EMA/FDA guideline requirements for both safety and efficacy," said Dr Silke Aigner, responsible Head of Clinical Strategy & Development for IgG Next Generation. "This is the second pivotal clinical study generating positive phase III results. In 2019, we completed study no. 992 - a phase III study investigating IgG Next Generation as immunomodulatory therapy in patients diagnosed with chronic primary immune thrombocytopenia (ITP)".Results of both studies will be submitted together to the health authorities. Following approval, IgG Next Generation can be marketed in additional established indications of intravenous immunoglobulins, in particular replacement therapy in secondary immunodeficiency disease (e.g. chronic lymphocytic leukaemia, multiple myeloma, after allogeneic haematopoietic stem cell transplantation) and as immunomodulatory therapy in Guillain Barré Syndrome (GBS), Kawasaki disease, Multifocal motor neuropathy (MMN) and Chronic inflammatory demyelinating polyneuropathy (CIDP).In 2019, the market volume of immunoglobulins solely for the indication PID in US and EU amounted to approximately $3.0 billion.IgG Next Generation is manufactured using an innovative production process and will be the master product of the new Biotest Next Level manufacturing facility currently under construction. This new manufacturing facility, which uses state of the art technologies, represents Biotest's latest commitment to the global immunoglobulin markets.About study no. 991 Study no. 991 is a phase III, open-label, prospective, multicentre trial and will investigate the clinical efficacy, safety, and pharmacokinetic properties of IgG Next Generation as replacement therapy in paediatric and adult patients diagnosed with primary immunodeficiency disease (PID). Patients previously receiving IVIg (immunoglobulins for intravenous use) treatment are switched to infusions with IgG Next Generation and treated for 12 months. The initial dose and dosage intervals will be kept consistent with the patient's pre-study IVIg treatment. The primary objective of this study is to demonstrate that IgG Next Generation provides effective protection against infection by supplementing and maintaining a normal level of immunoglobulin in the patients' body. According to EMA/FDA guidelines on the clinical investigation of immunoglobulin, the rate of acute serious bacterial infections (SBI) per patient year should be less than one to provide substantial evidence of efficacy. An SBI is defined as bacterial pneumonia, bacteraemia and septicaemia, osteomyelitis/septic arthritis, bacterial meningitis or visceral abscess. More information about the study design can be found at www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT02810444).About Primary Immunodeficiency Disease (PID) Primary Immunodeficiency Diseases are a group of currently 200 identified hereditary and genetic disorders, in which some of the body's immune defences are absent or dysfunctional. It is estimated that worldwide at least 10 million children and adults may be affected by PID. One of the most common signs of PID is an increased susceptibility to a wide range of germs like bacteria, viruses and fungi that can cause infections. Infections in patients diagnosed with PID are more frequent, longer lasting or harder to treat than are the infections of someone with a normal immune system. Patients with PID typically require life-long immunoglobulin replacement therapy to prevent recurrent infections.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 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.IR contact Dr Monika Buttkereit Phone: +49-6103-801-4406 Mail: investor_relations@biotest.dePR contact Dirk Neumüller Phone: +49-6103-801-269 Mail: pr@biotest.comBiotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.comOrdinary 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, TradegateDisclaimer 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. * * *01.09.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de * * * 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 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange EQS News ID: 1125539 End of News DGAP News Service

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