Research, Development, Innovation

Bayer Group expenses for research and development rose by 17.4% (Fx adj.) to €1,110 million in the first quarter of 2016, with the Life Science businesses accounting for €1,046 million of this figure (Fx adj. 18.0%).

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q1 2015

Q1 2016

Change

 

Q1 2015

Q1 2016

Change

2015 figures restated

1

Including reconciliation

 

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

Pharmaceuticals

 

533

700

+30.8

 

533

667

+24.6

Consumer Health

 

52

58

+11.5

 

50

56

+12.0

Crop Science

 

240

262

+10.4

 

240

262

+10.4

Animal Health

 

33

30

−9.1

 

33

30

−9.1

Total Life Sciences1

 

887

1,046

+18.0

 

885

1,011

+14.2

Covestro

 

59

64

+8.5

 

59

64

+8.5

Total Group

 

946

1,110

+17.4

 

944

1,075

+14.0

Capital expenditures for property, plant and equipment and intangible assets amounted to €363 million (Q1 2015: €345 million), including €317 million (Q1 2015: €256 million) in the Life Science businesses.

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

Heart failure

Prevention of thrombosis2

Endometriosis

Recurrent / resistant non-Hodgkin lymphoma (NHL)

Renal anemia

Serious eye diseases3

Wet age-related macular degeneration3

Bone metastases in breast cancer

Cancer, various studies

Cancer

Pulmonary hypertension (IIP)

Diffuse systemic sclerosis

Cystic fibrosis

Secondary prevention of acute coronary syndrome (ACS)4

Chronic heart failure

Symptomatic uterine fibroids

Endometriosis

1 As of April 15, 2016
2 Sponsored by Ionis Pharmaceuticals, Inc.
3 Sponsored by Regeneron 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 the first quarter of 2016, the study involving BAY 1007626 or progestin IUS (contraceptive) was ended. Clinical development of roniciclib (cancer) will be discontinued. Bayer does not intend to pursue the development of refametinib (cancer) and the project will be returned to Ardea BioSciences, Inc., United States.

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

Prostate cancer

Hemophilia A

Pulmonary infection

Various forms of non-Hodgkin lymphoma (NHL)

Diabetic kidney disease

Combination treatment of castration-resistant prostate cancer

Refractory liver cancer

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

1 As of April 15, 2016
2 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.

At present, we intend to focus our development activities for finerenone on the indication of diabetic kidney disease. For this reason, a study in the indication of chronic heart failure will not be performed.

The most important drug candidates in the approval process are:

Products Submitted for Approval1

Indication

E.U., U.S.A.; contraception

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

1 As of April 15, 2016

2 Submitted by Janssen Research & Development, LLC

In February 2016, Bayer received approval from the European Commission for Kovaltry™ (Bay 81‑8973) for the treatment of hemophilia A in patients of all age groups. Kovaltry™ is an unmodified recombinant factor VIII product that in clinical trials has demonstrated efficacy and tolerability as an on-demand therapy and for prophylactic use two or three times per week by hemophilia A patients. In March 2016, Kovaltry™ was approved by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW).

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.

In February 2016, we launched our fifth global crowdsourcing initiative with Grants4Indications™.

In March 2016, we expanded our existing cooperation with Regeneron Pharmaceuticals, Inc., United States, to jointly develop a combination therapy of the angiopoietin2 (Ang2) antibody nesvacumab and aflibercept for the treatment of serious eye diseases. Two ongoing Phase II clinical studies are evaluating the combination therapy as a coformulated single intravitreal injection in patients with wet age-related macular degeneration or diabetic macular edema.

Consumer Health

At Consumer Health, research and development activities focus on the development of nonprescription (over-the-counter = OTC) medications for pain and allergy relief, as well as skin and foot care products, sunscreens, dietary supplements and other self-care products.

In the first quarter of 2016, we expanded our MiraLax™ product line to include the laxative MiraFiber™. This fiber-based dietary supplement is available in the United States in drink powder and tablet form.

Crop Science

In February 2016, Crop Science announced that it had acquired the Germany-based diagnosis and warning service provider proPlant Gesellschaft für Agrar- und Umweltinformatik mbH. The company develops and markets IT solutions for the European agricultural sector and will operate in the future as Bayer Digital Farming GmbH. The acquisition continues the expansion of the division’s activities in the field of digitization in agriculture.

Animal Health

In January 2016, Animal Health submitted an application to the E.U. regulatory authorities for approval of a new product to protect honey bees against the Varroa mite. It is based on the proven active substance flumethrin.

Covestro

In March 2016, Covestro announced a collaboration with Tokyo-based NANODAX Co., Ltd., to develop innovative polycarbonate composites reinforced with glass wool for which NANODAX has developed a special production process. Both companies see good prospects for future use of the reinforced plastics in automotive, IT and electronics applications.