Research, Development, Innovation

Bayer Group expenses for research and development rose by 7.2% (Fx adj.) to €1,122 million in the third quarter of 2016, with the Life Science businesses accounting for €1,055 million of this figure (Fx adj. +7.4%).

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q3 2015

Q3 2016

 

Change

 

9M 2015

9M 2016

 

Change

 

Q3 2015

Q3 2016

 

Change

 

9M 2015

9M 2016

 

Change

 

 

€ million

€ million

 

Fx. adj. %

 

€ million

€ million

 

Fx. adj. %

 

€ million

€ million

 

Fx. adj. %

 

€ million

€ million

 

Fx. adj. %

2015 figures restated

1

Including reconciliation

Pharmaceuticals

 

607

682

 

+12.7

 

1,721

2,061

 

+20.1

 

606

679

 

+12.3

 

1,717

2,025

 

+18.3

Consumer Health

 

62

64

 

+5.0

 

179

193

 

+9.4

 

58

56

 

–2.6

 

168

172

 

+3.7

Crop Science

 

266

282

 

+7.1

 

772

815

 

+7.4

 

266

281

 

+6.7

 

772

807

 

+6.4

Animal Health

 

30

35

 

+16.0

 

95

99

 

+4.9

 

30

35

 

+16.0

 

95

99

 

+5.3

Total Life Sciences1

 

974

1,055

 

+7.4

 

2,826

3,160

 

+10.3

 

969

1,042

 

+8.0

 

2,811

3,094

 

+10.9

Covestro

 

65

67

 

+3.1

 

192

193

 

+0.5

 

65

67

 

+3.1

 

191

193

 

+1.0

Total Group

 

1,039

1,122

 

+7.2

 

3,018

3,353

 

+9.7

 

1,034

1,109

 

+7.7

 

3,002

3,287

 

+10.3

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

Serious eye diseases2

Heart failure

Prevention of thrombosis3

Recurrent / resistant non-Hodgkin lymphoma (NHL)

Renal anemia

Chronic heart failure

Wet age-related macular degeneration2

Breast cancer with bone metastases

Cancer, various studies

Cancer

Diffuse systemic sclerosis

Cystic fibrosis

Secondary prevention of acute coronary syndrome (ACS)4

Symptomatic uterine fibroids

Endometriosis

1 As of October 13, 2016
2 Sponsored by Regeneron Pharmaceuticals, Inc.
3 Sponsored by Ionis Pharmaceuticals, Inc.
4 Sponsored by Janssen Research & Development, LLC
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 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 September 2016, our partner Regeneron Pharmaceuticals, Inc., United States, published the first data from a clinical Phase II study investigating the treatment of wet age-related macular degeneration with rinucumab, a PDGFR-β antibody, in combination with aflibercept (tradename: Eylea™). While the study failed to meet its primary endpoint of a statistically significant improvement in visual acuity after 12 weeks, it is being continued by Regeneron as planned and further data will be analyzed after 28 weeks as well as following the conclusion of the trial (after 52 weeks). Bayer will then analyze the available data and decide on the next steps.

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

Research and Development Projects (Phase III)1

Indication

Pulmonary infection

Nonmetastatic castration-resistant prostate cancer

Metastatic hormone-sensitive prostate cancer

Non-cystic fibrosis bronchiectasis

Various forms of non-Hodgkin lymphoma (NHL)

Hemophilia A

Diabetic kidney disease

Combination treatment of castration-resistant prostate cancer

Refractory liver cancer

Colon cancer, adjuvant therapy

Pulmonary arterial hypertension (PAH) in patients who do not sufficiently respond to PDE-5i / ERA

Prevention of major adverse cardiac events (MACE)

Anticoagulation in patients with chronic heart failure2

Long-term prevention of venous thromboembolism

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

Embolic stroke of undetermined source (ESUS)

Peripheral artery disease (PAD)

Pulmonary infection

Chronic heart failure3

1 As of October 13, 2016
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 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 September 2016, a clinical Phase III study was initiated to investigate vericiguat, a soluble guanylate cyclase (sGC) stimulator, in patients suffering from chronic heart failure with reduced ejection fraction. The development and commercialization of vericiguat are part of the worldwide strategic collaboration between Bayer and Merck, United States (through a subsidiary), in the field of sGC modulation.

The most important drug candidates in the approval process are:

Products Submitted for Approval1

Indication

U.S.A.; secondary prophylaxis of acute coronary syndrome (ACS)

1 As of October 13, 2016

2 Submitted by Janssen Research & Development, LLC

Also in September 2016, the U.S. Food and Drug Administration (FDA) approved our new low-dose levonorgestrel-releasing intrauterine system with the brand name Kyleena™. The new system releases the lowest daily hormone dose in an intrauterine system for up to five years of effective protection against pregnancy. It uses the smallest plastic T-shaped body in a hormone-releasing intrauterine system available today. In October 2016, furthermore, we successfully completed the corresponding decentralized registration procedure for the European Union. On this basis, it is expected that the health authorities of the E.U. member states will grant national authorizations in the coming months.

Cooperation

In July 2016, we expanded our research collaboration with biotech company X-Chem, Inc., United States, for the development of novel small molecule therapeutics. The partnership covers multiple therapeutic areas and extends Bayer’s access to X-Chem’s DEX™ technology, which is based on DNA-encoded libraries of small molecules with more than 120 billion molecules. The aim of the collaboration is to discover innovative lead structures for complex drug targets in areas of high unmet medical need.

In August 2016, we entered into a five-year, multitarget research partnership with Evotec AG, Hamburg, Germany, to develop multiple clinical candidates for the treatment of kidney diseases such as chronic kidney disease in diabetes patients. Both companies will contribute novel drug targets and a comprehensive set of high-quality technology platforms, and will hold joint responsibility for the preclinical development of potential clinical candidates.

In September 2016, we signed a collaboration and technology license agreement with DelSiTech Ltd., Turku, Finland, for the worldwide application of DelSiTech’s Silica Matrix drug delivery platform to a number of Bayer’s compounds in ophthalmology.

Consumer Health

In July 2016, we expanded our Alka-Seltzer™ product family in the United States to include another cold medicine in the Alka-Seltzer Plus™ line.

Crop Science

In July 2016, the E.U. Commission approved the dual herbicide tolerance trait Balance™ GT in soybeans for food and feed uses. Balance GT is owned by MS Technologies and is being codeveloped through a joint development agreement between that company and Bayer. The launch of soybeans with this new trait is planned for 2017, pending approval by the regulatory authorities.

In September 2016, Crop Science announced a five-year research partnership with the Jülich Research Center, Germany, that is focused on phenotyping for plant breeding, research into plant traits and the development of biologics.

Covestro

After successfully commissioning a novel foam production facility in Dormagen in June 2016 that reduces the input of petrochemical raw materials through the use of CO2, Covestro announced the Dream Resource research project in September 2016. Together with partners from industry and science, Covestro intends to investigate how CO2 can be used as a component in insulating foam and other products of the plastics industry. The three-year initiative will be supported by the German Ministry for Education and Research (BMBF).