Research for Medical Progress for the Benefit of the Patient
Bayer is the only global company simultaneously researching improvements in human, animal and plant health. Systematic and intensive collaboration among researchers beyond their original specialization is providing new impetus. From world-renowned pharmaceutical products to high-tech platforms, from innovative diagnostics technologies to veterinary medicines – Bayer lives an innovation culture across national borders and areas of research.
Research Areas at Bayer
Our division Pharmaceuticals focuses on indications with high medical need in the areas of cardiovascular disease, oncology, gynecology, ophthalmology and hematology. We conduct research and development activities at several locations, mainly in Germany, the United States, Japan, China, Finland and Norway.
2018, we were able to transfer five new molecular entities from our research pipeline into preclinical development. We define a new molecular entity (NME) as a new chemical or biological substance that has not been in development to date. In preclinical trials these substances are examined further in various models with respect to their suitability for clinical trials and the associated “first-in-man” studies.
In 2018, we conducted clinical trials with several drug candidates from our research and development pipeline. We strengthened products that were already on the market through additional development activities to further improve their application and / or expand their spectrum of indications.
Clinical trials are an essential tool for determining the efficacy and safety of new drugs before they can be used to diagnose or treat diseases. The benefits and risks of new medicinal products must always be scientifically proven and well documented. All clinical trials at Bayer satisfy strict international guidelines and quality standards, as well as the respective applicable national laws and standards.
Examples of Pharmaceuticals' Recent Filings & Approvals:
Adempas™ (active ingredient: riociguat) is the first member of a new class of vasodilation agents known as soluble guanylate cyclase (sGC) modulators. Administered in tablet form, riociguat is currently being investigated as an innovative, specific approach for the treatment of various forms of pulmonary hypertension.
Adempas™ is approved in the United States and Europe for the treatment of particular forms of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). In Japan, Bayer was granted marketing authorization for CTEPH in 2014 and for PAH in February 2015.
The trial program for riociguat also includes studies outside of the pulmonary hypertension indication. For example, riociguat is also in Phase II testing for the treatment of patients with diffuse systemic sclerosis.
Stivarga™ (active ingredient: regorafenib) is an oral multikinase inhibitor. It inhibits various signal pathways that are responsible for tumor growth. Stivarga™ is approved in the United States, Europe, Japan and other countries for the treatment of patients with metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumors (GIST).
In November 2016, an expansion of indications was filed for Stivarga™ (active ingredient: regorafenib) in the United States, Japan and Europe. The filings pertain to the second-line treatment of patients with unresectable hepatocellular carcinoma. Stivarga™, an oral multikinase inhibitor, is already approved under this brand name in numerous countries for the treatment of metastatic colorectal cancer and unresectable or metastatic gastrointestinal stromal tumors. The U.S. Food and Drug Administration (FDA) granted priority review status to regorafenib in the registration process for the expansion of indications (supplemental New Drug Application, sNDA). The Japanese Ministry of Health, Labour and Welfare (MHLW) granted priority review status for the registration filing in January 2017.
Stivarga™ was developed by Bayer. In 2011, Bayer and Onyx Pharmaceuticals, Inc., a subsidiary of Amgen Inc., United States, agreed that Onyx would receive royalties on global sales of Stivarga™ in the area of cancer treatment.
Xofigo™ (active ingredient: radium-223 dichloride) is approved in the E.U. and the United States for the treatment of adult patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases but no known visceral metastases.
In March 2016, the Japanese MHLW granted marketing authorization for Xofigo™ (radium‑223 dichloride) for the treatment of adult patients with castration-resistant prostate cancer and bone metastases.
Eylea™ (active ingredient: aflibercept) is our joint development project with Regeneron Pharmaceuticals, Inc., United States. Aflibercept blocks the natural growth factor VEGF (vascular endothelial growth factor), thus preventing the abnormal formation of new blood vessels that tend to leak fluid. The medication is administered directly into the eye. Regeneron Pharmaceuticals, Inc., United States, holds exclusive rights to the product in the United States, while in other countries it is marketed by Bayer.
Eylea™ is approved for the treatment of wet age-related macular degeneration (AMD), visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) and diabetic macular edema (DME). In Japan, Eylea™ is additionally approved for the treatment of myopic choroidal neovascularization (mCNV).
In February 2015, the European Commission extended marketing authorization for Eylea™ to include the treatment of patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO). Eylea™ therefore can be used in Europe by all patients with visual impairment due to macular edema resulting from retinal vein occlusion (RVO). In June 2015, the product was approved in this indication in Japan. In October 2015, Eylea™ was approved by the European Commission for the treatment of myopic choroidal neovascularization (mCNV).
A Phase IIa clinical study with regorafenib eye drops did not show the desired results and the project is therefore being discontinued. The study investigated the use of regorafenib for the treatment of wet age-related macular degeneration (AMD).
Xarelto™ (active ingredient: rivaroxaban) has been approved for more indications in the area of venous and arterial thromboembolism than any of the other non-vitamin-K-dependent oral anticoagulants. Xarelto™ is approved in more than 130 countries worldwide across all indications, its approval status varying from country to country. Xarelto™ is marketed in the United States by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.
In May 2015, Xarelto™ was approved by the China Food and Drug Administration (CFDA) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis (DVT). The approval also includes the use of Xarelto™ to reduce the risk of recurrent DVT and pulmonary embolism following acute DVT. In September 2015, Xarelto™ was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment and secondary prevention of pulmonary thromboembolism and deep vein thrombosis.
In addition to the already approved indications, the use of rivaroxaban is also being investigated in other cardiovascular diseases such as prevention of major adverse cardiac events, embolic stroke of undetermined source or peripheral artery disease.
Rivaroxaban was invented by Bayer and is being jointly developed with Janssen Research & Development, LLC, United States, a subsidiary of Johnson & Johnson.
The aim of our research and development activities in the area of contrast agents and medical equipment (Radiology business unit) is to steadily improve our contrast agents and our contrast injection systems in order to build on our leadership position in the field of radiology.
In March 2015, we received approval in Japan for Gadovist™ (active ingredient: gadobutrol) injection for use with resonance imaging (MRI). Gadovist™ is the first high concentration / high relaxivity gadolinium-based contrast agent to be made available in Japan. In July 2015, Gadovist™ was approved by the European Commission for use in children under two years of age. This label extension applies to all indications that have already been approved.
In August 2015, the MRXperion injection system was approved by the FDA for the injection of contrast agents. Our system optimizes injection workflow, provides enhanced point-of-care capabilities and can be connected to our Radimetrics™ Enterprise platform.
In 2015, we also worked to expand the capabilities of our informatics product offerings by developing new software applications to improve contrast agent and radiation dosage management across CT, MRI and nuclear medicine modalities.
In May 2016, the U.S. Food and Drug Administration (FDA) approved Gadavist™ / Gadovist™ (active ingredient: gadobutrol) as the first contrast agent for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in patients of all ages.
In November 2018, larotrectinib (tradename: Vitrakvi™) was approved in the United States for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.
The approval also applies to patients with tumors with an NTRK gene fusion that are either metastatic or where surgical resection is likely to result in severe morbidity, and for patients who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
The active substance larotrectinib was designed to specifically block the signaling pathway responsible for tumor growth. In August 2018, Bayer filed an application seeking approval of larotrectinib in the European Union as well.
AT Consumer Health, we concentrate on developing new nonprescription (OTC) products and solutions that improve the health and well-being of consumers in the areas of pain relief, dermatology, dietary supplements, digestive health, allergy relief and cold symptoms, as well as foot care. The focus lies on product developments that are aligned to the desires and needs of consumers. Our innovations range from new product formulations and packaging to technical applications and medical devices. In 2018, we developed around 40 new consumer validated concepts, significantly exceeding our plans for the year. Consumer Health maintains a global network of research and development facilities, with sites in the United States, France, Germany and China. Another important part of our strategy is transferring current prescription medicines that are suitable for self-care to OTC status (Rx-to-OTC switches).