Research & Innovation

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. In 2013 Bayer HealthCare, with R&D spending of €2.04 billion, accounted for some 64 percent of all R&D expenditures by the Bayer Group.

The division Pharmaceuticals carries out research and product development mainly in the fields of Cardiology and Hematology, Oncology, Women’s Healthcare and Diagnostic Imaging. Topical examples of the results of pharmaceutical research are:

Examples of new active ingredients from Pharmaceuticals research:

Riociguat

Riociguat is the first member of a new class of vasodilating agents known as soluble guanylate cyclase (sGC) stimulators. Administered in tablet form, riociguat is currently being investigated as a new approach for the treatment of various forms of pulmonary hypertension. Based on the Phase III studies CHEST-1 and PATENT-1, we submitted riociguat in February 2013 for marketing approval in the United States and the European Union for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). We received the first approval in the indication CTEPH in September 2013 in Canada. In October 2013, following priority review, the FDA approved riociguat in the U.S. under the trade name Adempas™ for use in CTEPH and PAH. In January 2014, we received approval for Adempas™ for the treatment of CTEPH in Japan, and in the European approval process, the European Committee for Medicinal Products for Human Use (CHMP) recommended that riociguat be approved to treat CTEPH and PAH. A final decision from the European Commission is expected in the first half of 2014.

Regorafenib

Stivarga™ (active ingredient: regorafenib) is a novel, oral multikinase inhibitor. It inhibits various signal pathways that are responsible for tumor growth. Stivarga™ was approved in the United States in 2012 for the treatment of patients with metastatic colorectal cancer (mCRC). The Japanese Ministry of Health, Labour and Welfare (MHLW) approved the product in this indication in March 2013. In August 2013, the product was approved in the European Union. In February 2013, the FDA approved Stivarga™ to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) who have been previously treated with imatinib and sunitinib. In August 2013, Stivarga™ was approved by the Japanese MHLW for the treatment of GIST. In September 2013, the product was submitted for approval in this indication in the European Union. Regorafenib is a compound developed by Bayer and co-promoted by Bayer and Onyx Pharmaceuticals, Inc., a subsidiary of Amgen Inc., in the United States. In 2011, we signed an agreement with Onyx under which that company receives a royalty on any future global sales of Stivarga™ in oncology.

Ra223 Dichloride

Xofigo™ (active ingredient: radium-223 dichloride), a cancer drug jointly developed with Algeta ASA, Norway, received FDA approval in May 2013 to treat adult patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastases. In November 2013, the product was approved in this indication in the European Union. In the United States, Xofigo™ is co-promoted with Algeta US, LLC. We are jointly developing and commercializing our cancer drug Nexavar™ (active ingredient: sorafenib) with Onyx Pharmaceuticals, Inc., United States. The successful active ingredient sorafenib, which targets both cancer cells and the vascular system of the tumor, has been registered for the treatment of advanced renal cell carcinoma since 2005 and hepatocellular carcinoma since 2007. We plan to develop the product beyond these two therapeutic areas with a broadly based life-cycle management program. Based on the clinical Phase III DECISION study, we submitted sorafenib to the European Medicines Agency (EMA) and the FDA in June 2013 for regulatory approval in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine. The FDA granted this approval in November 2013 following a priority review. In September 2013, sorafenib was submitted to the Japanese MHLW for marketing authorization for the treatment of thyroid cancer. Sorafenib is also being investigated in Phase III registration studies as an adjuvant therapy following curative tumor resection in patients with renal cell carcinoma or hepatocellular carcinoma. We are also conducting Phase III registration studies in breast cancer.

Aflibercept

Eylea™ (active ingredient: aflibercept) is our joint developmental 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 blood. The medication is administered directly into the eye. Regeneron Pharmaceuticals holds exclusive rights in the United States, where Eylea™ is approved for the treatment of wet age-related macular degeneration (AMD) and treatment of macular edema secondary to central retinal vein occlusion (CRVO). Bayer markets the product outside the United States. Eylea™ has been approved since 2012 in Europe, Japan, Australia and additional countries for the treatment of wet AMD. In August 2013, the European Commission approved Eylea™ for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). In November 2013, Eylea™ was approved by the Japanese MHLW for the treatment of CRVO. The first regulatory submissions in two further indications were made in November 2013: we applied to the EMA for approval of aflibercept in the treatment of diabetic macular edema (DME) and to the Japanese MHLW for approval in the treatment of choroidal neovascularization caused by pathologic myopia (mCNV). In the area of hematology, a clinical Phase II / III trial with the developmental substance BAY 86-6150 did not show the desired results and was discontinued ahead of schedule in May 2013. The trial investigated the efficacy and safety of the substance in people with hemophilia A and hemophilia B in whom antibodies to coagulation factors had developed.

Sorafenib

We are jointly developing and commercializing our cancer drug Nexavar™ (active ingredient: sorafenib) with Onyx Pharmaceuticals, Inc., United States. The successful active ingredient sorafenib, which targets both cancer cells and the vascular system of the tumor, has been registered for the treatment of advanced renal cell carcinoma since 2005 and hepatocellular carcinoma since 2007. We plan to develop the product beyond these two therapeutic areas with a broadly based life-cycle management program. Based on the clinical Phase III DECISION study, we submitted sorafenib to the European Medicines Agency (EMA) and the FDA in June 2013 for regulatory approval in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine. The FDA granted this approval in November 2013 following a priority review. In September 2013, sorafenib was submitted to the Japanese MHLW for marketing authorization for the treatment of thyroid cancer. Sorafenib is also being investigated in Phase III registration studies as an adjuvant therapy following curative tumor resection in patients with renal cell carcinoma or hepatocellular carcinoma. We are also conducting Phase III registration studies in breast cancer.

Rivaroxaban

Xarelto™ (active ingredient: rivaroxaban) has been approved for more indications than any of the other new oral anticoagulants. Xarelto™ is registered in the following indications in the United States and Europe:


  • prevention of venous thromboembolism (VTE) in adult patients after elective hip or knee joint replacement surgery
  • prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors
  • treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults
  • prevention of recurrent DVT and PE in adults

In May 2013, Xarelto™ was additionally approved by the European Commission for the prevention of atherothrombotic events after acute coronary syndrome (ACS) in patients with elevated cardiac biomarkers in combination with standard antiplatelet therapy. In January 2014, the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the approval of Xarelto™ for the treatment of ACS. The FDA will consider the Advisory Committee’s recommendations in its review of the application for approval of rivaroxaban in this indication but is not bound by them. Xarelto™ is marketed in the U.S. by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson. Beyond the already approved indications, rivaroxaban is also being investigated in other cardiovascular disorders. Ongoing clinical Phase III trials include COMPASS and COMMANDER-HF. The aim of the COMPASS study is to investigate the potential of rivaroxaban in the prevention of major adverse cardiac events. The COMMANDER-HF study is evaluating the potential additional benefit of rivaroxaban in combination with standard therapy in reducing the risk of mortality, myocardial infarction and stroke in patients with chronic heart failure and significant coronary heart disease. Xarelto™ is approved in more than 125 countries worldwide across all indications, its approval status varying from country to country.

Rivaroxaban was discovered by HealthCare and jointly developed with Janssen Research & Development, LLC.

Extensive information on research and development at Bayer HealthCare:

Animal Health

Research and development activities in the Animal Health Division focus on antibiotics, parasiticides and substances to treat non-infectious diseases in animals. more

Consumer Care

Research and development activities in the Consumer Care Division are aimed at identifying, developing and commercializing non-prescription products. more

Medical Care

The research and development activities of our Medical Care Division focus on blood glucose monitoring and the continuing development of medical equipment used in the diagnosis or treatment of various diseases. We are also investing to expand further segments such as medical data management systems. more

Pharmaceuticals

The research and development activities of Pharmaceuticals are focused on the identification and development of new active substances for diseases with a high medical need. more

Further information on research at Bayer HealthCare can be found in our research scientific magazine:

Last updated: September 22, 2014 Copyright © Bayer AG
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