Research, Development, Innovation

Bayer Group expenses for research and development increased by 5.5% (Fx adj.) to €1,079 million in the third quarter of 2017.

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q3 2016

Q3 2017

Change

 

9M 2016

9M 2017

Change

 

Q3 2016

Q3 2017

Change

 

9M 2016

9M 2017

Change

 

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

Pharmaceuticals

 

682

688

+2.9

 

2,061

2,107

+2.2

 

679

687

+3.3

 

2,025

2,004

−0.9

Consumer Health

 

64

56

−9.5

 

193

180

−6.8

 

56

55

+1.6

 

172

171

−0.9

Crop Science

 

282

281

+2.0

 

815

839

+2.4

 

281

281

+2.1

 

807

836

+3.0

Animal Health

 

35

35

+0.9

 

99

106

+6.2

 

35

34

−0.9

 

99

105

+5.6

Reconciliation

 

(8)

19

.

 

(8)

38

.

 

(9)

19

.

 

(9)

38

.

Total Group

 

1,055

1,079

+5.5

 

3,160

3,270

+3.7

 

1,042

1,076

+6.6

 

3,094

3,154

+2.2

Pharmaceuticals

We are conducting clinical trials with several drug candidates from our research and development pipeline.

The following table shows our most important drug candidates currently in Phase II of clinical testing:

Research and Development Projects (Phase II)1

Indication

Cancer

Heart failure

Peripheral artery disease (PAD)

Prevention of thrombosis

Prevention of thrombosis2

Relapsed / refractory diffuse large B-cell lymphoma

Renal anemia

Chronic heart failure

Serious eye diseases3

Breast cancer with bone metastases

Cancer

Cancer

Diffuse systemic sclerosis

Endometriosis

1 As of October 6, 2017
2 Sponsored by Ionis Pharmaceuticals, Inc.
3 Sponsored by Regeneron Pharmaceuticals, Inc.
The nature of drug discovery and development is such that not all compounds can be expected to meet the predefined project goals. It is possible that any or all of the projects listed above may have to be discontinued due to scientific and / or commercial reasons and will not result in commercialized products. It is also possible that the requisite U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other regulatory approvals will not be granted for these compounds. Moreover, we regularly review our research and development pipeline so that we can give priority to advancing the most promising pharmaceuticals projects.

Bayer reported in July 2017 that a Phase II clinical trial evaluating Bayer’s oncological development candidate anetumab ravtansine, also known as BAY 949343, as a monotherapy in previously treated patients with advanced malignant pleural mesothelioma (MPM) did not meet its primary endpoint of progression-free survival. The safety and tolerability of anetumab ravtansine corresponded with observations from previous trials. Aside from this, anetumab ravtansine is currently being reviewed in other clinical trials as both a monotherapy and in combination with other drugs, including in a Phase Ib multi-indication study of six different types of advanced solid tumors and a Phase Ib combination study in patients with recurrent platinum-resistant ovarian cancer.

Bayer began a clinical Phase II trial in 2014 on the safety, tolerability and efficacy of riociguat in adult cystic fibrosis patients with the delta F508 gene mutation. The preliminary analysis of selected data from the first part of the trial indicated that there was no evidence of a positive trend in the efficacy of riociguat. A continuation of the trial was not considered meaningful at that time. In August 2017, Bayer decided to terminate the trial ahead of schedule. No concerns were raised about the safety of riociguat.

The following table shows our most important drug candidates currently in Phase III of clinical testing:

Research and Development Projects (Phase III)1

Indication

Gram negative pulmonary bacterial infection

Various forms of non-Hodgkin lymphoma (NHL)

Castration-resistant nonmetastatic prostate cancer

Hormone-sensitive metastatic prostate cancer

Diabetic kidney disease

Combination treatment of castration-resistant prostate cancer

Colon cancer, adjuvant therapy

Prevention of major adverse cardiac events (MACE)

Anticoagulation in patients with chronic heart failure2

Prevention of venous thromboembolism in high-risk patients after discharge from hospital2

Peripheral artery disease (PAD)

Pulmonary infection

Chronic heart failure3

Symptomatic uterine fibroids

1 As of October 6, 2017
2 Sponsored by Janssen Research & Development, LLC
3 Sponsored by Merck & Co., Inc., USA
The nature of drug discovery and development is such that not all compounds can be expected to meet the predefined project goals. It is possible that any or all of the projects listed above may have to be discontinued due to scientific and / or commercial reasons and will not result in commercialized products. It is also possible that the requisite U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other regulatory approvals will not be granted for these compounds. Moreover, we regularly review our research and development pipeline so that we can give priority to advancing the most promising pharmaceuticals projects.

In August 2017, Bayer presented positive results at the European Society of Cardiology (ESC) Congress from the Phase III COMPASS trial – the largest such clinical trial of rivaroxaban to date – evaluating Factor Xa inhibitor Xarelto™ (active ingredient: rivaroxaban) in the vascular dose of 2.5 mg twice daily in combination with 100 mg of Aspirin™ once daily compared with only a 100 mg dose of Aspirin™ once daily. With the combined treatment approach of rivaroxaban and Aspirin™, the risk of stroke in patients with chronic coronary or peripheral artery disease was reduced by 42% and the risk of cardiovascular death by 22%. The relative risk of stroke, cardiovascular death and heart attack was reduced by 24%. Bleeding rates were low, and, although major bleeding complications were more frequent, there was no significant increase in intracranial or fatal bleeding. The combined treatment approach significantly improved the net clinical benefit by 20%.

In October 2017, Bayer and its development partner Janssen Research & Development, LLC, announced that the Phase III NAVIGATE ESUS trial was terminated ahead of schedule. The trial investigated the efficacy and safety of Xarelto™ (active ingredient: rivaroxaban) for the secondary prevention of strokes and systemic embolisms in patients who had recently suffered an embolic stroke of unknown source. Following a planned interim analysis conducted by the independent Data Monitoring Committee (DMC), the DMC recommended that the trial be terminated early since the efficacy of rivaroxaban compared with acetylsalicylic acid (ASS) was similar in the treatment groups and only offered limited potential for additional clinical benefit to patients if the trial continued.

The most important drug candidates in the approval process are:

Main Products Submitted for Approval1

Indication

U.S.A.: Non-cystic fibrosis bronchiectasis

Europe, U.S.A.: Hemophilia A

Europe, U.S.A.: long-term prevention of venous thromboembolic events

U.S.A.: secondary prophylaxis of acute coronary syndrome (ACS), rivaroxaban in combination with dual antiplatelet therapy (DAPT); ATLAS trial

1 As of October 6, 2017

2 Submitted by Janssen Research & Development, LLC

In August 2017, Bayer received approval from the European Commission to modify the prescribing information for the oral Factor Xa inhibitor Xarelto™ (active ingredient: rivaroxaban) based on PIONEER Phase III study data. The information now includes a recommendation for the use of Xarelto in patients with non-valvular atrial fibrillation who undergo percutaneous coronary intervention with stent placement and require oral anticoagulation. The recommendation pertains to the use of Xarelto 15 mg once daily in combination with a P2Y12 inhibitor for a maximum period of 12 months.

The European Commission approved the oral multi-kinase inhibitor Stivarga (active ingredient: regorafenib) for an additional indication in August 2017. The approval relates to the treatment of adult patients with hepatocellular carcinoma (HCC), who had previously been treated with Nexavar (active ingredient: sorafenib). Stivarga is the first medicine to show a significant improvement in overall survival in second-line treatment of patients with HCC for whom there was previously no further treatment option. The product had been approved for second-line treatment of HCC in the United States in April 2017 and in Japan in June 2017.

Also in August 2017, the United States Food and Drug Administration (FDA) granted priority review status to Bayer’s application for the investigational drug ciprofloxacin DPI (Dry Powder for Inhalation) for the treatment of adults with noncystic fibrosis bronchiectasis (NCFB). In June 2017, Bayer applied for approval of the combination product. The application is based on the data from the RESPIRE global Phase III trial program. The FDA has scheduled an Antimicrobial Drugs Advisory Committee meeting for November 16, 2017 to discuss the ciprofloxacin DPI application.

In early September 2017, Bayer applied for marketing authorization to the European Medicines Agency (EMA) for the long-acting site-specifically PEGylated recombinant human Factor VIII (damoctocog alfa pegol) for the treatment of patients with Hemophilia A. The regulatory submission is based on the data from the PROTECT VIII trial. In that trial, damoctocog alfa pegol provided protection from bleeds when used prophylactically once every seven days, once every five days, or twice per week. Bayer had already submitted an application for an authorization to manufacture biopharmaceutical products (Biologics License Application, BLA) for damoctocog alfa pegol to the U.S. Food and Drug Administration (FDA) in August 2017.

In September 2017 as well, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted Bayer another positive opinion for its oral Factor Xa inhibitor Xarelto™ (active ingredient: rivaroxaban) based on the data of the EINSTEIN CHOICE Phase III trial. This expands the approval to include a once daily 10 mg dose of rivaroxaban for the extended prevention of recurrent venous thromboembolism (VTE). The final decision of the European Commission is expected by the end of 2017.

In September 2017, the United States Food and Drug Administration (FDA) likewise granted Bayer approval for copanlisib, which will be sold under the tradename Aliqopa™ in the future, for the treatment of previously treated patients with relapsed follicular B-cell non-Hodgkin lymphoma. The accelerated approval was granted based on the results of the CHRONOS-1 Phase II trial including 142 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease had relapsed after two previous treatments, of which 104 patients had follicular B-cell non-Hodgkin lymphoma. The approval was issued on the basis of the overall response rate and must still be confirmed in a further trial. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.

In August 2017, Bayer and Vanderbilt University Medical Center in Nashville, Tennessee, United States, signed a five-year strategic research alliance to fight kidney disease.

Crop Science

In July 2017, Bayer and the Israeli company Netafim, which is based in Tel Aviv, joined forces to enhance the application of crop protection products. The new approach, called “DripByDrip”, will enable farmers to water their fields and apply crop protection products in a more targeted way using Netafim’s drip irrigation technology. The first launch is scheduled to take place in Mexico at the end of 2017.

In August 2017, Bayer and the Citrus Research and Development Foundation (CRDF), a non-profit organization supporting citrus growers in Florida, signed a research collaboration agreement to find solutions to Citrus Greening disease, which currently threatens the global citrus production and juice industry.

In addition, Bayer and Rothamsted Research, Harpenden, United Kingdom, formed a strategic alliance in August 2017 to develop holistic solutions to meet the individual needs of farmers. New technologies are also set to be deployed and developed as part of the alliance.

Bayer and the non-profit organization Quantified Plant, Vaxholm, Sweden, signed a licensing and cooperation agreement in August 2017. Under the agreement, Bayer is providing proprietary, crowd-sourced data from more than 70 countries on certain plant varieties and their location, prevalence and distribution. Quantified Planet makes this data available worldwide for use in scientific research in the field of biodiversity.

The new TwinLink Plus™ cotton technology was launched on the U.S. market in September 2017. With three modes of action against insect pests added to the double herbicide tolerance, it provides season-long protection and further improves resistance management.

In addition, Bayer and Bosch, Germany, signed a three-year cooperation agreement in September 2017, with the objective of developing a smart spraying technology to make the application of crop protection products more efficient and facilitate a more targeted use of herbicides.

Bayer and the Greek Institute of Molecular Biology and Biotechnology, which forms part of the Foundation of Research and Technology Hellas (IMBB-FORTH), announced a five-year research collaboration in September 2017. This collaboration will involve research into insect gut physiology, with the goal of developing new insecticides.

In addition, Bayer and Ginkgo Bioworks, Inc., United States, founded a new company focused on the plant microbiome in September 2017. The innovative joint venture will concentrate on transformational beneficial microbes for plants to minimize agriculture’s environmental impact. The company will have sites in Boston and Sacramento, United States.