Overview
Overview
Research at Bayer
Research at Bayer
Research at Bayer HealthCare
Research and development at Bayer HealthCare focus on identifying and developing new active substances to treat diseases with a high unmet medical need. Bayer HealthCare, with R&D spending of EUR 1.7 billion in 2007, accounted for 66 percent of all R&D expenditures in the Bayer Group.
In its internal research for active ingredients, Bayer Schering Pharma AG, Germany* concentrates on four core areas: Oncology, Cardiology, Women´s Healthcare, and Diagnostic Imaging.The R&D activities of Bayer Schering Pharma are focused on the identification and development of new active substances for diseases with a high medical need.
Examples of new active ingredients from Pharmaceuticals research:
BAY 58-2667 is a novel substance that is undergoing clinical trials for the treatment of acute decompensated heart failure.
Acute heart failure is the most common cause of hospital admissions in patients over 65 years of age. There is an urgent need for improved therapy options for patients with acute heart failure, as both morbidity and mortality in the disease are very high.
BAY 58-2667 activates soluble guanylate cyclase (sGC), a key enzyme in a signal cascade with central significance in the regulation of the cardiovascular system. It is activated by the endogenously formed gas nitrogen monoxide (NO) and in its active form catalyzes the formation of cyclic guanosine monophosphate (cGMP). This neurotransmitter cGMP acts as a "second messenger" and leads, for example, to the dilatation of vessels, has a blood-pressure-lowering effect and mediates tissue-protective effects.
In preclinical and clinical studies to date, BAY 58-2667 showed efficacy and tolerability. There has been no evidence of developing tolerance to the substance. A Phase IIb study in this indication is planned to start this year.
Fact sheets: Bayer Schering Pharma development projects
Acute heart failure is the most common cause of hospital admissions in patients over 65 years of age. There is an urgent need for improved therapy options for patients with acute heart failure, as both morbidity and mortality in the disease are very high.
BAY 58-2667 activates soluble guanylate cyclase (sGC), a key enzyme in a signal cascade with central significance in the regulation of the cardiovascular system. It is activated by the endogenously formed gas nitrogen monoxide (NO) and in its active form catalyzes the formation of cyclic guanosine monophosphate (cGMP). This neurotransmitter cGMP acts as a "second messenger" and leads, for example, to the dilatation of vessels, has a blood-pressure-lowering effect and mediates tissue-protective effects.
In preclinical and clinical studies to date, BAY 58-2667 showed efficacy and tolerability. There has been no evidence of developing tolerance to the substance. A Phase IIb study in this indication is planned to start this year.
Fact sheets: Bayer Schering Pharma development projectsBAY 63-2521 is an innovative oral active substance with the potential to become a new treatment option for pulmonary hypertension.
Pulmonary hypertension is a rare and life-threatening disorder in which the blood vessels in the lungs are constricted. This increases the blood pressure in these vessels, which overburdens the heart and may even lead to heart failure. The symptoms are non-specific, and accordingly, the disorder is frequently either not diagnosed or diagnosed too late. Pulmonary hypertension has a mortality rate similar to that of cancer. One of the established treatment options for pulmonary hypertension is the prostacyclin analogue iloprost from Bayer Schering Pharma.
BAY 63-2521 stimulates soluble guanylate cyclase (sGC), a key enzyme in a signaling cascade with central significance in the regulation of the cardiovascular system. sGC is activated by the endogenously formed gas nitrogen monoxide (NO) and in its active form catalyzes the formation of cyclic guanosine monophosphate (cGMP). The neurotransmitter cGMP acts as a "second messenger", and leads, for example, to the dilatation of blood vessels, has a blood-pressure-lowering effect, and mediates tissue-protective effects.
In preclinical and clinical studies to date, BAY 63-2521 was well tolerated, and no serious adverse effects occurred. Phase III studies in the indication pulmonary hypertension are scheduled to start in 2008.
Fact sheets: Bayer Schering Pharma development projects
Pulmonary hypertension is a rare and life-threatening disorder in which the blood vessels in the lungs are constricted. This increases the blood pressure in these vessels, which overburdens the heart and may even lead to heart failure. The symptoms are non-specific, and accordingly, the disorder is frequently either not diagnosed or diagnosed too late. Pulmonary hypertension has a mortality rate similar to that of cancer. One of the established treatment options for pulmonary hypertension is the prostacyclin analogue iloprost from Bayer Schering Pharma.
BAY 63-2521 stimulates soluble guanylate cyclase (sGC), a key enzyme in a signaling cascade with central significance in the regulation of the cardiovascular system. sGC is activated by the endogenously formed gas nitrogen monoxide (NO) and in its active form catalyzes the formation of cyclic guanosine monophosphate (cGMP). The neurotransmitter cGMP acts as a "second messenger", and leads, for example, to the dilatation of blood vessels, has a blood-pressure-lowering effect, and mediates tissue-protective effects.
In preclinical and clinical studies to date, BAY 63-2521 was well tolerated, and no serious adverse effects occurred. Phase III studies in the indication pulmonary hypertension are scheduled to start in 2008.
Fact sheets: Bayer Schering Pharma development projectsVEGF Trap-Eye is currently being tested in a Phase II trial for the treatment of the wet form of age-related macular degeneration.
Age-related macular degeneration (AMD) is one of the most common non-infectious acquired causes of blindness. Macular degeneration is diagnosed either as dry (non-exudative) or wet (exudative). In the case of wet AMD, new blood vessels grow behind the retina, leaking blood and fluid. The collections of fluid cause swelling and disrupt the normal functioning of the retina, leading to "blind spots" in the central field of vision, and can result in blindness among patients with wet AMD.
VEGF (Vascular Endothelial Growth Factor) is a natural growth factor that stimulates the formation of new blood vessels (angiogenesis) and is produced by the body during the growth of tissue and organs, as well as in healing wounds. VEGF is also connected to the abnormal formation of new vessels and their fragility in the eye, which leads to the development of wet AMD. VEGF Trap-Eye is a human, soluble VEGF receptor fusion protein, which binds all types of VEGF-A as well as the related placental growth factor (PlGF). VEGF Trap-Eye specifically blocks these growth factors and therefore has a high potential for efficacy.
Positive results from a planned interim analysis of the Phase II study were presented in May 2007 at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). Bayer HealthCare and Regeneron are planning the start of a Phase III clinical trial program with VEGF Trap-Eye in the second half of 2007.
Fact sheets: Bayer Schering Pharma development projects
Age-related macular degeneration (AMD) is one of the most common non-infectious acquired causes of blindness. Macular degeneration is diagnosed either as dry (non-exudative) or wet (exudative). In the case of wet AMD, new blood vessels grow behind the retina, leaking blood and fluid. The collections of fluid cause swelling and disrupt the normal functioning of the retina, leading to "blind spots" in the central field of vision, and can result in blindness among patients with wet AMD.
VEGF (Vascular Endothelial Growth Factor) is a natural growth factor that stimulates the formation of new blood vessels (angiogenesis) and is produced by the body during the growth of tissue and organs, as well as in healing wounds. VEGF is also connected to the abnormal formation of new vessels and their fragility in the eye, which leads to the development of wet AMD. VEGF Trap-Eye is a human, soluble VEGF receptor fusion protein, which binds all types of VEGF-A as well as the related placental growth factor (PlGF). VEGF Trap-Eye specifically blocks these growth factors and therefore has a high potential for efficacy.
Positive results from a planned interim analysis of the Phase II study were presented in May 2007 at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). Bayer HealthCare and Regeneron are planning the start of a Phase III clinical trial program with VEGF Trap-Eye in the second half of 2007.
Fact sheets: Bayer Schering Pharma development projectsRivaroxaban (BAY 59-7939) is a novel oral, once-daily anticoagulant: a drug that has the potential to prevent or treat blood clots. Rivaroxaban specifically inhibits Factor Xa in the coagulation system, thereby controlling the generation of thrombin, an enzyme that facilitates clotting.
Rivaroxaban is in advanced clinical development for the effective prevention and treatment of venous and arterial thrombosis in acute and chronic indications. The development program is comprehensive, with almost 40,000 patients expected to be evaluated in 13 Phase II-III studies, spanning several indications, including prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery, treatment of VTE, prevention of stroke in patients with atrial fibrillation, and prevention of major cardiovascular events in patients with acute coronary syndrome.
Patients are at an increased risk for thromboembolic disease following orthopedic surgery. Currently, patients undergoing orthopedic surgery are given LMWHs or vitamin K antagonists (VKAs) to prevent VTE. Parenteral administration of LMWHs limits their use outside the hospital setting, making it difficult to follow therapy guidelines – which recommend treatment for up to several weeks. To date, vitamin K antagonists are the only treatment that can be administered orally, but their onset of action is slow and their effectiveness varies significantly from one patient to another. Moreover, these substances have numerous interactions with other drugs and with some foods, which means their efficacy needs to be monitored closely by regular blood tests and the dosage may have to be adjusted frequently. The first application for marketing authorization in the prevention of VTE following major orthopedic surgery is planned for the end of 2007 in Europe and for 2008 in the United States.
Rivaroxaban has the opportunity to be a novel anticoagulant therapy because it is intended to provide a safe, effective, oral, once-daily option that can be used in both the hospital and home settings without the need for routine monitoring. This is why rivaroxaban is a promising drug candidate for both prevention and treatment in acute and chronic settings, from hospital to home.
Fact sheets: Bayer Schering Pharma development projects
Rivaroxaban is in advanced clinical development for the effective prevention and treatment of venous and arterial thrombosis in acute and chronic indications. The development program is comprehensive, with almost 40,000 patients expected to be evaluated in 13 Phase II-III studies, spanning several indications, including prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery, treatment of VTE, prevention of stroke in patients with atrial fibrillation, and prevention of major cardiovascular events in patients with acute coronary syndrome.
Patients are at an increased risk for thromboembolic disease following orthopedic surgery. Currently, patients undergoing orthopedic surgery are given LMWHs or vitamin K antagonists (VKAs) to prevent VTE. Parenteral administration of LMWHs limits their use outside the hospital setting, making it difficult to follow therapy guidelines – which recommend treatment for up to several weeks. To date, vitamin K antagonists are the only treatment that can be administered orally, but their onset of action is slow and their effectiveness varies significantly from one patient to another. Moreover, these substances have numerous interactions with other drugs and with some foods, which means their efficacy needs to be monitored closely by regular blood tests and the dosage may have to be adjusted frequently. The first application for marketing authorization in the prevention of VTE following major orthopedic surgery is planned for the end of 2007 in Europe and for 2008 in the United States.
Rivaroxaban has the opportunity to be a novel anticoagulant therapy because it is intended to provide a safe, effective, oral, once-daily option that can be used in both the hospital and home settings without the need for routine monitoring. This is why rivaroxaban is a promising drug candidate for both prevention and treatment in acute and chronic settings, from hospital to home.
Fact sheets: Bayer Schering Pharma development projectsNexavar (sorafenib) was first approved for the treatment of patients with advanced renal cancer at the end of 2005 and is currently approved in more than 50 countries, including the United States and in the European Union. On the strength of the data obtained from a Phase III study (SHARP), we are now in the process of preparing applications to the U.S. Food and Drug Administration (FDA) and European health authorities for a new indication for Nexavar® in the treatment of patients with liver cancer.
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world and the third leading cause of cancer-related deaths globally.
Recent data show a broad development potential for sorafenib in the area of oncology. Hence, sorafenib is being tested as a mono- and combination therapy in various other cancer indications. This research includes the possible adjuvant therapy of renal carcinoma, melanoma, breast cancer, and non-small cell lung cancer(NSCLC).
Sorafenib is a multi-kinase inhibitor with a dual-action mechanism against cancer. It targets both the tumor cell and tumor vasculature, which are existential for tumor growth. In preclinical studies, sorafenib has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. Preclinical models have also demonstrated that the Raf/MEK/ERK-pathway has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Fact sheets: Bayer Schering Pharma development projects
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world and the third leading cause of cancer-related deaths globally.
Recent data show a broad development potential for sorafenib in the area of oncology. Hence, sorafenib is being tested as a mono- and combination therapy in various other cancer indications. This research includes the possible adjuvant therapy of renal carcinoma, melanoma, breast cancer, and non-small cell lung cancer(NSCLC).
Sorafenib is a multi-kinase inhibitor with a dual-action mechanism against cancer. It targets both the tumor cell and tumor vasculature, which are existential for tumor growth. In preclinical studies, sorafenib has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. Preclinical models have also demonstrated that the Raf/MEK/ERK-pathway has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Fact sheets: Bayer Schering Pharma development projectsThe novel anti-cancer agent sagopilone (ZK-EPO) is currently being tested in an extensive program of clinical Phase II studies in various oncological indications. The fully synthetic epothilone should show improved efficacy and safety in comparison with commonly used chemotherapeutics and is designed to also retain its efficacy within the cells of tumors with multiple resistance.
Currently, an extensive program of Phase II studies is being conducted with sagopilone in Europe and North America. In the clinical studies, the novel epothilone is being tested in various oncological indications. These include ovarian and breast cancer as well as prostate cancer and various types of lung cancer.
Sagopilone is a stabilizer of microtubules that is rapidly taken up into the cell and inhibits the division of cancer cells. Moreover, sagopilone is not recognized by the so-called efflux pumps, through which other drugs are transported out of the cell. The bypassing of this mechanism represents an important approach in the development of cancer therapies.
Fact sheets: Bayer Schering Pharma development projects
Currently, an extensive program of Phase II studies is being conducted with sagopilone in Europe and North America. In the clinical studies, the novel epothilone is being tested in various oncological indications. These include ovarian and breast cancer as well as prostate cancer and various types of lung cancer.
Sagopilone is a stabilizer of microtubules that is rapidly taken up into the cell and inhibits the division of cancer cells. Moreover, sagopilone is not recognized by the so-called efflux pumps, through which other drugs are transported out of the cell. The bypassing of this mechanism represents an important approach in the development of cancer therapies.
Fact sheets: Bayer Schering Pharma development projectsThe antibody alemtuzumab is currently undergoing testing in a three-year Phase II clinical study (CAMMS223) for the treatment of multiple sclerosis (MS). Interim results of the study presented in May 2007 following two years of therapy demonstrated positive results for efficacy. Currently, two Phase III studies are in preparation which should start before the end of 2007. The antibody has been approved for the treatment of chronic lymphocytic B-cell leukemia (B-CLL) since 2001.
Multiple sclerosis (MS) is a serious chronic disease, in which the immune system attacks the brain and spinal cord of the affected person. The disease causes a wide range of symptoms including fatigue, gait disorders, feelings of numbness, and visual disorders. In advanced stages, it can cause severe disability. The most frequent form of the disease is relapsing-remitting MS. Across the world, approximately 2.5 million patients have MS, with approximately twice as many women as men being affected. MS cannot be cured. There are many therapies for the treatment of MS, but because of their limited efficacy there is still a major need for innovative therapeutic options.
Alemtuzumab is a humanized monoclonal antibody that binds specifically to the CD52 antigen on the surface of B- and T-cells, thus marking them as targets for destruction by the body's own immune system. The causes of multiple sclerosis have not been fully elucidated. It is assumed that autoreactive B- and T-cells play an important part in the disease-related events of this autoimmune condition. Treatment with alemtuzumab pursues a novel approach in the therapy of MS, in that these cells are targeted and destroyed.
Fact sheets: Bayer Schering Pharma development projects
Multiple sclerosis (MS) is a serious chronic disease, in which the immune system attacks the brain and spinal cord of the affected person. The disease causes a wide range of symptoms including fatigue, gait disorders, feelings of numbness, and visual disorders. In advanced stages, it can cause severe disability. The most frequent form of the disease is relapsing-remitting MS. Across the world, approximately 2.5 million patients have MS, with approximately twice as many women as men being affected. MS cannot be cured. There are many therapies for the treatment of MS, but because of their limited efficacy there is still a major need for innovative therapeutic options.
Alemtuzumab is a humanized monoclonal antibody that binds specifically to the CD52 antigen on the surface of B- and T-cells, thus marking them as targets for destruction by the body's own immune system. The causes of multiple sclerosis have not been fully elucidated. It is assumed that autoreactive B- and T-cells play an important part in the disease-related events of this autoimmune condition. Treatment with alemtuzumab pursues a novel approach in the therapy of MS, in that these cells are targeted and destroyed.
Fact sheets: Bayer Schering Pharma development projectsExtensive information on research and development at Bayer HealthCare:
Investor Day 2007
On June 19, 2007, the Bayer management presented the future strategy of Bayer HealthCare to the invited financial analysts at the Bayer Investor Day in Leverkusen, Germany. The topics included the integration of Schering AG, product and R&D strategy as well as comprehensive updates on the Bayer Schering Pharma pipeline and the Consumer Health business. You will find more information in the digital press kit.
On June 19, 2007, the Bayer management presented the future strategy of Bayer HealthCare to the invited financial analysts at the Bayer Investor Day in Leverkusen, Germany. The topics included the integration of Schering AG, product and R&D strategy as well as comprehensive updates on the Bayer Schering Pharma pipeline and the Consumer Health business. You will find more information in the digital press kit.
Animal Health
The main focus is the health of farm animals (cattle, pigs, poultry) and companion animals (dogs, cats, horses). Research and Development activities in the Animal Health Division concentrate on antibiotics, parasite control and active substances for the treatment of non-infectious diseases. This latter category includes kidney failure, pain therapy, cancer and inflammatory heart failure.
Diabetes Care
The main emphasis in the Diabetes Care Division is on strengthening the core product lines. A combination of internal development and collaboration with partners enables the division to offer customers user-friendly blood glucose monitoring systems that meet the individual needs of people with diabetes. One of the main areas of research is minimally invasive and continuous measuring technologies, the long-term aim being to allow monitoring without painful invasive blood sampling.
Consumer Health
Research and development activities in the Consumer Care Division focus on the identification, development and market introduction of non-prescription products. Research activities concentrate on support for current brands and the implementation of product-related, clinical and regulatory development strategies. This work opens up the possibility of exploiting new technologies, additional indications for existing drug products and the reclassification of previously prescription medications as over-the-counter products.
07.01.2008: 26th Annual JPMorgan Healthcare Conference, San Francisco
- Arthur J. Higgins, Chairman of the Board of Management BHC Presentation
(PDF 636 KB)
Further information on research at Bayer HealthCare can be found in our research scientific magazine:
19th edition
Anti-cancer medicineA vice-like grip on the cytoskeleton:Sagopilone shows promise in combating tumors
Good detective work: Searching for active substances using RNA interferenceTreating tumors by blocking hormones: New active ingredient for treatment of breast cancerThe replenishers: Cancer stem cells provide new understanding of tumor developmentFormulation research: Aspirin®Visualizing memory loss: Early identification of Alzheimer’sTiny Trojan horses: Nanocapsules transport active ingredients directly to their site of actionEarly protection: New study of acetylsalicylic acid in cardiovascular preventionThe sweet danger: Innovative blood glucose meters make life safer for diabeticsMultifaceted impact: Structural analysis of crystals is aiding in pharmaceutical resarchPortrait of a cancer researcher: “Only happy researchers are good researchers”Current edition 19
18th edition
Thrombosis live: The vascular system in fine detailHelp for weak hearts: Cardiovascular disease Be calm, my beating heart: Substance which controls raised heart rates High-potential multitalent: Aspirin® 18th edition17th edition
16th edition
When genes are silent: An effective method could revolutionize the search for active ingredients Hunting molecules in 3D: Molecular modeling helps to optimize active ingredients Combating dangerous blood clots: Innovative thrombosis prevention 16th edition*
The names "Bayer Schering Pharma" or "Schering" as used in this website always refer to Bayer Schering Pharma AG, Berlin, Germany, or its predecessor, Schering AG, Berlin, Germany, respectively.
Bookmark this page
E-mail this page
All Bayer Science Podcasts
