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.

How Drugs are Developed

From Molecules to Medicine

Research Areas at Bayer

Pharmaceuticals

Research Area Pharmaceuticals - Development of Drugs and Medications

Dr. Jürgen Klar and Dr. Michael Böttger (left to right) from Bayer in Wuppertal evaluate images showing the condition of the blood vessels at the back of the eye.


Drug discovery in the Pharmaceuticals segment focuses on the areas of cardiology, oncology, ophthalmology, hematology, radiology and gynecology.

Examples of New Active Ingredients from Pharmaceuticals Research:

Riociguat

Adempas™ (active ingredient: riociguat) is the first member of a new class of vasodilating agents known as soluble guanylate cyclase (sGC) modulators. Administered in tablet form, riociguat is currently being investigated as a new, specific approach for the treatment of various forms of pulmonary hypertension.

Adempas™ was approved in the United States in 2013 for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH). In March 2014, Adempas™ was also approved by the European Commission in both indications. In Japan, the drug was approved for CTEPH in January 2014 and was submitted for approval to treat PAH in April 2014.

In 2014 the study program for riociguat was expanded to include new trials: a Phase IIIb pilot study was launched in March 2014 to evaluate the effect of riociguat in patients with PAH who demonstrated an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) either as a monotherapy or in combination with an endothelin receptor antagonist (ERA). In June 2014, we commenced the Phase IIb study RISE-IIp to investigate the safety and efficacy of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonia (IIp). Outside of the pulmonary hypertension indication, riociguat is also in Phase II testing for the treatment of patients with diffuse systemic sclerosis.

Another representative of the sGC modulator class is vericiguat, currently in Phase IIb clinical testing to treat chronic heart failure.

Since October 2014, we have been collaborating with Merck & Co., Inc., on the development and commercialization of sGC modulators.

Finerenone is a next-generation oral non-steroidal mineralcorticoid receptor antagonist that is currently in Phase IIb clinical development for the treatment of worsening chronic heart failure and diabetic nephropathy.

In the cardiorenal syndrome area, molidustat is being investigated for the treatment of patients with anemia accompanied by chronic kidney disease and/or terminal kidney failure.

Regorafenib

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 several other countries for the treatment of patients with metastatic colorectal cancer (mCRC). In 2013, Stivarga™ was also approved in the United States, Japan and other countries for the treatment of gastrointestinal stromal tumors (GIST). In July 2014, the European Commission granted approval for the treatment of GIST.

In February 2014, we initiated a Phase III trial investigating the effect of regorafenib as an adjuvant treatment option for colorectal cancer patients following resection of liver metastases with curative intent and completion of all planned chemotherapy.

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.

Ra-223-Dichlorid

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 April 2014, a new Phase III trial began that is evaluating radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic patients with bone-predominant metastatic castration-resistant prostate cancer who have not received chemotherapy.

Afilibercept

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, Inc. holds exclusive rights to the product in the United States, while in other countries it is marketed by Bayer.

Eylea™ is approved in more than 80 countries for the treatment of wet age-related macular degeneration (AMD). In 2013, Eylea™ was also approved in Europe, Japan, the United States and further countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). In August 2014, the European Commission approved Eylea™ in the treatment of diabetic macular edema (DME). The Japanese MHLW approved Eylea™ in this indication in November 2014.

In September 2014, the MHLW approved Eylea™ for the treatment of myopic choroidal neovascularization (mCNV). Pathologic myopia and the associated myopic CNV is the second most common cause of blindness in Japan.

In February 2015 Bayer received the EU Approval for Eylea™ for the treatment of patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO). This new indication includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion in adults (CRVO). The approval for Japan followed in June 2015.

Sorafenib

We are jointly developing and commercializing our cancer drug Nexavar™ (active ingredient: sorafenib) with Onyx Pharmaceuticals, Inc., United States. The active ingredient sorafenib, which targets both cancer cells and the vascular system of the tumor, is registered in more than 100 countries for the treatment of liver cancer and advanced kidney cancer. In May 2014, Nexavar™ was approved by the European Commission for the treatment of patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma refractory to radioactive iodine. In June 2014, the Japanese MHLW approved sorafenib for the treatment of patients with unresectable differentiated thyroid carcinoma.

Two clinical Phase III trials with sorafenib failed to meet their respective primary endpoints in March and July 2014. The trials investigated sorafenib as an adjuvant treatment for hepatocellular carcinoma and as a combination therapy for breast cancer.

Rivaroxaban

Xarelto™ (active ingredient: rivaroxaban) has been approved for more indications in the area of venous and arterial thromboembolism than any of the other new oral anticoagulants. Xarelto™ is approved in more than 125 countries worldwide across all indications, its approval status varying from country to country.

In February 2014, the FDA issued complete response letters in connection with the U.S. approval process in the prevention of atherothrombotic events secondary to acute coronary syndrome (ACS). A new Phase II study will now investigate rivaroxaban in combination with a single platelet aggregation inhibitor for long-term prevention in patients with ACS. Xarelto™ is marketed in the United States by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.

In May 2014, we submitted rivaroxaban to the Japanese Ministry of Health, Labor and Welfare (MHLW) for marketing authorization to treat patients with deep vein thrombosis and pulmonary embolism and for the prevention of recurrent venous thromboembolism.

Beyond the already approved indications, rivaroxaban is also being investigated in other cardiovascular disorders. Ongoing Phase III clinical 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 the prevention of cardiovascular events in patients with chronic heart failure and significant coronary heart disease.

In 2014, the study program for rivaroxaban was expanded to include new trials: the EINSTEIN CHOICE trial is evaluating two different doses of rivaroxaban for the long-term, secondary prevention of deep vein thrombosis and pulmonary embolism. The MARINER trial is evaluating the efficacy and safety of rivaroxaban to reduce the risk of post-hospital-discharge symptomatic venous thromboembolism (VTE) in patients who were hospitalized for acute medical illness. The ESUS NAVIGATE study is investigating the efficacy and safety of rivaroxaban in patients following embolic stroke of undetermined source. A further Phase III study (VOYAGER PAD) to investigate the efficacy and safety of rivaroxaban in patients with peripheral artery disease (PAD) following surgery is in preparation.

Rivaroxaban was invented by HealthCare and is being jointly developed with Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson.

Radiology

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. Our research and development centers are located near Pittsburgh, Pennsylvania, United States; in Toronto, Canada; in Berlin, Germany; and in Sydney, Australia. In June 2014, Gadavist™ (Gadobutrol) was approved by the FDA as the first contrast agent in magnetic resonance imaging (MRI) for detection and evaluation of breast cancer. In January 2015, Gadavist™ was the first contrast agent to receive FDA approval for use in children under two years of age. In 2014 we also worked to expand the capabilities of our informatics product offerings by developing new software and informatics to improve contrast agent and radiation dose management.

Consumer Health

Research Area Consumer Health - Research and Development of non-prescription medicines and supplement products

Andreas Werner (left) and Francesco Lo Grande clean and monitor the stirring rods of an ointment mixer for the production of Bepanthen™ wound and healing ointment.

In our Consumer Health Division, research and development activities at the product development centers in Morristown, New Jersey and Memphis, Tennessee, United States, and Gaillard, France, focus on developing non-prescription medicines, medical skincare products, foot care products, sunscreens and nutritional supplements to market maturity. Aligned to end consumers, our development strategies are geared toward expanding and improving our brand portfolio through new products and delivery forms. We also work to achieve reclassification of current prescription medicines as OTC products. We introduced a number of new product line expansions to various markets in 2014. They included new delivery forms and uses for existing brands such as Canesten™, Bepanthen™/Bepanthol™, Coppertone™ and Dr. Scholl’s™.

Animal Health

Research Area Animal Health - Research and Development of drugs for Animals and Pets.

Lab assistant Carolin Geier examinating round worms in a lab in Monheim.

In our Animal Health business unit, we focus our research and development activities on antiparasitics, antibiotics and medicines to treat non-infectious disorders. We operate R&D centers in Germany, the United States, New Zealand and Brazil. Our central research activities are conducted in Monheim, Germany. We reinforce the business by continually identifying further product development candidates through our existing collaborations.

Further Information on Research at Bayer HealthCare Can Be Found in Our research Scientific Magazine:

Last updated: January 6, 2016 Copyright © Bayer AG
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