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Pharmaceuticals Research and Development Pipeline
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Management Report
Pharmaceuticals Research and Development Pipeline
We announced in our 2006 Annual Report that the Pharmaceuticals Division’s research and development pipeline was under evaluation. Our research and development activities have now undergone a strategic realignment, representing a further milestone in the integration of Schering, Berlin, Germany.
Bayer’s drug discovery research will focus on four growth areas in the future: Oncology, Cardiology, Women’s Healthcare and Diagnostic Imaging. The clinical development of new products and further development of products already on the market will be maintained across all units.
The pharmaceuticals research and development pipeline comprises 20 projects in Phase III, 16 projects in Phase II and 14 projects in Phase I. A further 9 projects have already been submitted to the various regulatory authorities for marketing authorization. As part of the realignment, a total of 20 projects from the combined Bayer/Schering pipeline have been discontinued either for strategic reasons or due to low success prospects.
Recently presented Phase III study data on the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery show the anticoagulant rivaroxaban (BAY 59-7939) to be more effective than the current therapeutic standard enoxaparin. In this trial, patients treated with rivaroxaban were 49 percent less likely to suffer deep-vein thrombosis (DVT), pulmonary embolism or death than those treated with enoxaparin. An even greater (62 percent) reduction of risk of developing major VTE was observed in the patients treated with rivaroxaban, which also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6 percent and 0.5 percent, respectively). More than 2,500 patients were included in this Phase III trial on the prevention of venous thromboembolism after major knee replacement surgery. The trial forms part of rivaroxaban’s extensive development program. We intend to apply for marketing approval in this first indication by the end of this year in Europe and in 2008 in the United States. It is planned to market the product under the trade name Xarelto® following its approval by the regulatory authorities.
At the beginning of June 2007 we presented the results of a Phase III study involving our oncology product Nexavar® (sorafenib) in the treatment of liver cancer. The results show that Nexavar® increases overall survival by 44 percent over placebo in patients with advanced hepatocellular carcinoma. Liver cancer is among the most common types of cancer worldwide. As there is currently no approved treatment that can demonstrably increase overall survival in patients suffering from this disease, Nexavar® could have the potential to become the therapeutic standard. The dossiers for regulatory approval were submitted in the United States and the European Union in June 2007. Further clinical trials with Nexavar® are ongoing in other indications as well.
In the field of hematology, our pipeline has been strengthened by the successful inlicensing of a late-stage hemostasis project. Bayer HealthCare has acquired the commercialization rights outside the United States for recombinant human thrombin (rThrombin) from U.S.-based ZymoGenetics. The two companies plan to jointly market the product in the United States for the control of surgical bleeding.
Phase II clinical trials with a new formulation of our recombinant blood coagulation Factor VIII product Kogenate® are due to begin at the end of 2007. This formulation, based on liposome technology, could potentially prolong the product’s activity, thereby reducing the number of infusions needed and contributing significantly to the success of preventive therapy in hemophilia patients. Our developmental product would thus be the only long-acting Factor VIII product in clinical trials. Market introduction is planned for 2011 in Europe and 2012 in the United States.
Milestones have also been achieved for our cardiology pipeline, with three compounds demonstrating efficacy in various human heart diseases: BAY 58-2667 has been investigated in acute decompensated heart failure, BAY 63-2521 in patients with pulmonary hypertension, and BAY 68-4986 as a therapy for stable angina pectoris.
On top of these latest successes, we have defined clear objectives and expect 10 projects in our pipeline to reach Phase III clinical testing by the end of 2009. Alemtuzumab for the treatment of multiple sclerosis is scheduled to enter Phase III trials this year. The Phase III development program for VEGF Trap-Eye to treat serious eye diseases has now begun. In our early-stage pipeline, we aim to advance three drug candidates from preclinical development into Phase I clinical testing by the end of 2007. In our ongoing clinical trials, we also intend to demonstrate the efficacy of four more active substances in patients before the end of this year.
The following table shows the current status of the Phase III and II projects in our pharmaceuticals research and development pipeline:
Bayer’s drug discovery research will focus on four growth areas in the future: Oncology, Cardiology, Women’s Healthcare and Diagnostic Imaging. The clinical development of new products and further development of products already on the market will be maintained across all units.
The pharmaceuticals research and development pipeline comprises 20 projects in Phase III, 16 projects in Phase II and 14 projects in Phase I. A further 9 projects have already been submitted to the various regulatory authorities for marketing authorization. As part of the realignment, a total of 20 projects from the combined Bayer/Schering pipeline have been discontinued either for strategic reasons or due to low success prospects.
Recently presented Phase III study data on the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery show the anticoagulant rivaroxaban (BAY 59-7939) to be more effective than the current therapeutic standard enoxaparin. In this trial, patients treated with rivaroxaban were 49 percent less likely to suffer deep-vein thrombosis (DVT), pulmonary embolism or death than those treated with enoxaparin. An even greater (62 percent) reduction of risk of developing major VTE was observed in the patients treated with rivaroxaban, which also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6 percent and 0.5 percent, respectively). More than 2,500 patients were included in this Phase III trial on the prevention of venous thromboembolism after major knee replacement surgery. The trial forms part of rivaroxaban’s extensive development program. We intend to apply for marketing approval in this first indication by the end of this year in Europe and in 2008 in the United States. It is planned to market the product under the trade name Xarelto® following its approval by the regulatory authorities.
At the beginning of June 2007 we presented the results of a Phase III study involving our oncology product Nexavar® (sorafenib) in the treatment of liver cancer. The results show that Nexavar® increases overall survival by 44 percent over placebo in patients with advanced hepatocellular carcinoma. Liver cancer is among the most common types of cancer worldwide. As there is currently no approved treatment that can demonstrably increase overall survival in patients suffering from this disease, Nexavar® could have the potential to become the therapeutic standard. The dossiers for regulatory approval were submitted in the United States and the European Union in June 2007. Further clinical trials with Nexavar® are ongoing in other indications as well.
In the field of hematology, our pipeline has been strengthened by the successful inlicensing of a late-stage hemostasis project. Bayer HealthCare has acquired the commercialization rights outside the United States for recombinant human thrombin (rThrombin) from U.S.-based ZymoGenetics. The two companies plan to jointly market the product in the United States for the control of surgical bleeding.
Phase II clinical trials with a new formulation of our recombinant blood coagulation Factor VIII product Kogenate® are due to begin at the end of 2007. This formulation, based on liposome technology, could potentially prolong the product’s activity, thereby reducing the number of infusions needed and contributing significantly to the success of preventive therapy in hemophilia patients. Our developmental product would thus be the only long-acting Factor VIII product in clinical trials. Market introduction is planned for 2011 in Europe and 2012 in the United States.
Milestones have also been achieved for our cardiology pipeline, with three compounds demonstrating efficacy in various human heart diseases: BAY 58-2667 has been investigated in acute decompensated heart failure, BAY 63-2521 in patients with pulmonary hypertension, and BAY 68-4986 as a therapy for stable angina pectoris.
On top of these latest successes, we have defined clear objectives and expect 10 projects in our pipeline to reach Phase III clinical testing by the end of 2009. Alemtuzumab for the treatment of multiple sclerosis is scheduled to enter Phase III trials this year. The Phase III development program for VEGF Trap-Eye to treat serious eye diseases has now begun. In our early-stage pipeline, we aim to advance three drug candidates from preclinical development into Phase I clinical testing by the end of 2007. In our ongoing clinical trials, we also intend to demonstrate the efficacy of four more active substances in patients before the end of this year.
The following table shows the current status of the Phase III and II projects in our pharmaceuticals research and development pipeline:
| Research and development projects (Phases III and II) | ||
| Indication | Status | |
| Rivaroxaban | Prevention of venous thromboembolism | Phase III |
| Rivaroxaban | Stroke prevention in atrial fibrillation | Phase III |
| Rivaroxaban | Treatment of deep-vein thrombosis | Phase III |
| Nexavar® | Melanoma | Phase III |
| Nexavar® | Non-small-cell lung cancer | Phase III |
| Zevalin® | Non-Hodgkin lymphoma | Phase III |
| Campath® | Chronic lymphatic leukemia | Phase III |
| Bonefos® | Prevention of bone metastasis in breast cancer | Phase III |
| Combined oral contraceptive for dysmenorrhea (Japan) | Dysmenorrhea | Phase III |
| YAZ® Extended Regimen | Fertility control | Phase III |
| E2/DNG OC | Fertility control/excessive bleeding | Phase III |
| Mirena® Menorrhagia (USA) | Menorrhagia | Phase III |
| Angeliq® low-low | Menopause management | Phase III |
| Visanne® | Endometriosis | Phase III |
| Combined oral contraceptive containing folate | Fertility control | Phase III |
| LCS | Fertility control | Phase III |
| Betaferon® high dose (BEYOND) | Multiple sclerosis | Phase III |
| VEGF Trap-Eye | Wet age-related macular degeneration (AMD) | Phase III |
| Ultravist® 370 | Computed tomography | Phase III |
| Avelox® | New indications | Phase III |
| Adenosine A1 agonist | Atrial fibrillation/stable angina pectoris | Phase II |
| sGC activator | Acute heart failure | Phase II |
| sGC stimulator | Pulmonary hypertension | Phase II |
| Rivaroxaban | Acute coronary syndrome | Phase II |
| L19 interleukin 2 | Renal cell carcinoma | Phase II |
| ZK-PRA | Breast cancer | Phase II |
| Sagopilone (ZK-EPO) | Lung/ovarian/breast/prostate cancer | Phase II |
| Spheramine® | Parkinson’s disease | Phase II |
| Kogenate® | Formulation based on liposome technology | Phase II |
| Nexavar® | Breast cancer | Phase II |
| Nexavar® | Other solid tumors | Phase II |
| FC Patch | Fertility control | Phase II |
| Valette® Low | Fertility control | Phase II |
| Alemtuzumab | Multiple sclerosis | Phase II |
| Gadovist® | Magnetic resonance imaging | Phase II |
| Levitra® | New indications | Phase II |
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