Research, Development, Innovation

Bayer Group expenses for research and development rose by 3.0% (Fx adj.) to €1,165 million in the second quarter of 2017, with the Life Science businesses accounting for €1,097 million (Fx adj. +2,6%) of this figure.

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q2 2016

Q2 2017

Change

 

H1 2016

H1 2017

Change

 

Q2 2016

Q2 2017

Change

 

H1 2016

H1 2017

Change

 

 

€ million

€ million

Fx. adj. %

 

€ million

€ million

Fx. adj. %

 

€ million

€ million

Fx. adj. %

 

€ million

€ million

Fx. adj. %

Pharmaceuticals

 

679

707

+3.5

 

1,379

1,419

+1.9

 

679

638

−6.6

 

1,346

1,317

−3.1

Consumer Health

 

71

65

−8.6

 

129

124

−5.5

 

60

59

−3.3

 

116

116

−2.1

Crop Science

 

272

275

−0.4

 

533

558

+2.6

 

265

273

+1.5

 

526

555

+3.5

Animal Health

 

34

38

+10.3

 

64

71

+9.2

 

34

38

+10.3

 

64

71

+9.2

Reconciliation

 

4

12

.

 

0

19

.

 

4

12

.

 

0

19

.

Total Life Sciences1

 

1,060

1,097

+2.6

 

2,105

2,191

+2.8

 

1,042

1,020

−3.0

 

2,052

2,078

.

Covestro

 

62

68

+9.7

 

126

132

+4.0

 

62

68

+9.7

 

126

132

+4.0

Total Group

 

1,122

1,165

+3.0

 

2,231

2,323

+2.8

 

1,104

1,088

−2.4

 

2,178

2,210

+0.2

Pharmaceuticals

We are conducting clinical trials with a number of 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 thrombosis2

Relapsed / refractory diffuse large B-cell lymphoma

Renal anemia

Chronic heart failure

Serious eye diseases3

Breast cancer with bone metastases

Cancer, various studies

Cancer

Diffuse systemic sclerosis

Cystic fibrosis

Endometriosis

1 As of July 3, 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.

Based on the results of the GEMINI trial conducted by Janssen Research & Development, LLC, which had investigated rivaroxaban (tradename: Xarelto™) used in connection with a single antiplatelet therapy (SAPT) for the secondary prophylaxis of acute coronary syndrome (ACS), the decision was made to no longer pursue the development of rivaroxaban in this indication.

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

Non-cystic fibrosis bronchiectasis

Various forms of non-Hodgkin lymphoma (NHL)

Hemophilia A

Nonmetastatic castration-resistant prostate cancer

Metastatic hormone-sensitive 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

Embolic stroke of undetermined source (ESUS)

Peripheral artery disease (PAD)

Pulmonary infection

Chronic heart failure3

Symptomatic uterine fibroids

1 As of July 03, 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 July 2017, Bayer initiated the Phase III clinical trial program ASTEROID, which is investigating the development candidate vilaprisan in women with symptomatic uterine fibroids. The product of Bayer’s research efforts, vilaprisan is a novel oral and selective progesterone receptor modulator that is aimed at treating uterine fibroids long term.

The most important drug candidates in the approval process are:

Main Products Submitted for Approval1

Indication

U.S.A.: Recurrent / resistant non-Hodgkin lymphoma (NHL)

Europe: second-line treatment for unresectable liver cancer

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 July 3, 2017

2 Submitted by Janssen Research & Development, LLC

In April 2017, Bayer and its development partner Janssen Research & Development submitted an additional dose option for the oral Factor Xa inhibitor rivaroxaban (tradename: Xarelto™) to the U.S. Food and Drug Administration (FDA), seeking an expansion of indications. The application is supported by data from the EINSTEIN CHOICE trial. The new dose of 10mg of rivaroxaban once a day is to supplement the current therapy of 20mg once a day and is intended for use as an anticoagulation therapy to reduce the risk of recurrent venous thromboembolism after at least six months of standard therapy with anticoagulants.

In May 2017, the FDA granted priority review status to the development candidate copanlisib in the registration process, based on the Phase II data presented in the first quarter of 2017. The substance is being reviewed for the treatment of relapsed or refractory follicular lymphoma.

In April and June 2017, Bayer received approvals from the FDA and Japanese Ministry of Health, Labour and Welfare (MHLW) for the use of its oral multikinase inhibitor Stivagra™ (active ingredient: regorafenib) for the second-line treatment of patients with hepatocellular carcinoma who previously had been treated with Nexavar™ (active ingredient: sorafenib). Stivarga™ is the first drug product to show a significant improvement in overall survival in the second-line treatment of patients with hepatocellular carcinoma.

In June 2017, the European Committee for Medicinal Products for Human Use recommended the approval of Bayer’s cancer drug Stivarga™ (active ingredient: regorafenib) for the treatment of adult patients with hepatocellular carcinoma in the European Union who had previously been treated with Nexavar™ (active ingredient: sorafenib). The European Commission is expected to make a decision in the third quarter of 2017.

Collaborations

On April 6, 2017, Bayer decided to not exercise its option to further develop and market Wnt signaling pathway inhibitors, a class of biologics, as part of its collaboration with OncoMed Pharmaceuticals Inc., United States.

Crop Science

In April 2017, we received regulatory approval for the biological nematicide BioAct™ Prime DC in Greece. The new substance is intended for use in a variety of fruit and vegetables and directly targets eggs and larvae from nematode pests. The product is scheduled to be launched in Greece in 2017 and there are plans to gain approvals in other European countries, too.

In June 2017, Bayer and KWS SAAT SE, Germany – in line with their research cooperation which began in 2012 – granted a long-term license to the Belgian company SESVanderHave for their new CONVISO™SMART sugar beet cultivation system. The technology, which is based on conventionally cultivated sugar beet varieties that are tolerant to certain herbicides, makes weed management easier. It will initially be made available to farmers in 2018, mainly in Eastern and Northern Europe, and is to be introduced in the following years in Germany, France and Poland, among other countries.

We also signed a two-year research agreement with the Shanghai Institutes for Biological Sciences (SIBS) of the Chinese Academy of Sciences in June 2017. The purpose of the agreement is to increase wheat yields using new mathematical models and computer simulations for more efficient photosynthesis. The improvement in photosynthesis is considered to be a promising approach to considerably increasing plant productivity.

In June 2017, Bayer also signed an agreement with the Sumitomo Chemical Company, which is headquartered in Tokyo, Japan, for fungicide mixes used to control soybean diseases in Brazil. The companies plan to develop an effective substance to control widespread plant diseases such as soybean rust by combining a new fungicide produced by Sumitomo Chemical with established Bayer fungicides. Both companies expect to file a product registration application at the end of 2017.

Covestro

Covestro and its partners have developed a new procedure for producing the basic chemical aniline using industrial sugar. The chemical is used in the production of plastics. This means that benzene, a raw material derived from crude oil, can be replaced by biomass. The laboratory-tested procedure is now to be transferred to a larger pilot facility with the goal of manufacturing aniline on an industrial scale using renewable raw materials.