Research, Development, Innovation

Bayer Group expenses for research and development amounted to €1,040 million in the first quarter of 2018, matching the prior-year level (Fx adj. +0.0%).

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q1 2017

Q1 2018

Change

 

Q1 2017

Q1 2018

Change

 

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

Pharmaceuticals

 

712

693

+1.8

 

679

693

+6.8

Consumer Health

 

59

55

+1.9

 

57

55

+5.4

Crop Science

 

283

257

−3.7

 

282

254

−4.4

Animal Health

 

33

30

−3.6

 

33

30

−4.2

Reconciliation

 

7

5

−40.0

 

7

5

−40.0

Total Group

 

1,094

1,040

0.0

 

1,058

1,037

+3.1

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

Malignant pleural mesothelioma2

Endometriosis

Heart failure

Chronic kidney disease

Peripheral artery disease (PAD)

Prevention of thrombosis

Prevention of thrombosis3

Chronic heart failure

Serious eye diseases4

Breast cancer with bone metastases

Multiple myeloma

Systemic sclerosis

Endometriosis

1 As of April 5, 2018
2 This trial did not meet its primary endpoint. However, it has not yet been terminated. Additional studies investigating anetumab ravtansine as a treatment for different forms of solid tumors are ongoing. See the Bayer Annual Report 2017 for more information.
3 Sponsored by Ionis Pharmaceuticals, Inc.
4 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.

The Phase II study with copanlisib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL), was concluded. The results were presented at ASCO 2017 (American Society of Clinical Oncology). A Phase III study in this indication is not currently planned. Bayer continues to investigate copanlisib in a Phase III program pertaining to indolent NHL.

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

Research and Development Projects (Phase III)1

Indication

Various forms of non-Hodgkin lymphoma (NHL)

Castration-resistant nonmetastatic prostate cancer

Hormone-sensitive metastatic prostate cancer

Diabetic kidney disease

Renal anemia

Combination treatment of castration-resistant prostate cancer2

Anticoagulation in patients with chronic heart failure3

Prevention of venous thromboembolism in high-risk patients after discharge from hospital3

Peripheral artery disease (PAD)

VTE treatment in children

Chronic heart failure4

Symptomatic uterine fibroids

1 As of April 5, 2018
2 This trial was unblinded ahead of schedule and there are no patients who are still receiving the combination therapy. Otherwise, however, the trial is continuing, especially with regard to per protocol patient monitoring. The final assessment has not yet been completed. For more information see the Bayer Annual Report 2017.
3 Sponsored by Janssen Research & Development, LLC
4 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.

Bayer and the U.S. study network NSABP (National Surgical Adjuvant Breast and Bowel Project) decided to discontinue ahead of schedule a clinical Phase III study investigating the active substance regorafenib as an adjuvant therapy in colon carcinoma due to an insufficient number of participants.

In March 2018, Bayer and MSD International GmbH, a Group company of Merck & Co., Inc., decided to discontinue the joint development and commercialization of Sivextro™ (active ingredient: tedizolid phosphate) to treat infections of the skin and subcutaneous tissue. Bayer had inlicensed Sivextro™ in July 2011 for emerging markets and Japan. MSD will now continue to develop and market Sivextro™ in a number of these countries.

The most important drug candidates in the approval process are:

Main Products Submitted for Approval1

Indication

Europe, U.S.A., Japan: Hemophilia A

Europe, U.S.A.: Prevention of major adverse cardiac events (MACE), COMPASS trial

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

Solid tumors with NTRK gene fusions

1 As of April 5, 2018

2 Submitted by Janssen Research & Development, LLC

3 Submitted by Loxo Oncology, Inc.

In February 2018, Eylea™ (active ingredient: aflibercept solution for injection into the eye) was approved by the China Food and Drug Administration (CFDA) for the treatment of visual impairment due to diabetic macular edema. This is the first indication for which Eylea™ has obtained CFDA approval.

In March 2018, Bayer’s cooperation partner Loxo Oncology, Inc., Stamford, Connecticut, United States, completed the submission of a rolling New Drug Application (NDA) for larotrectinib in the United States. The registration application refers to the treatment of cancer patients suffering from locally advanced or metastatic solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusions. The active substance larotrectinib was designed to specifically block the signaling pathway responsible for tumor growth.

Crop Science

In February 2018, Bayer and Mitsui Chemicals Agro, Inc. (MCAG), headquartered in Tokyo, Japan, signed a license agreement granting Bayer an exclusive right to develop and commercialize the new fungicide quinofumelin worldwide except in certain selected countries. This product features a broad spectrum of action and is intended particularly for application in fruit tree crops, vegetables, oilseed rape / canola and rice.

At the beginning of March 2018, Bayer and the International Rice Research Institute (IRRI), headquartered in Los Baños, Philippines, signed an agreement confirming Bayer’s participation in the Direct Seeded Rice Consortium (DSRC) led by IRRI to drive forward modern rice cultivation technologies in Asia.

Also in March 2018, Bayer, Exeter University in the United Kingdom and Rothamsted Research, headquartered in Harpenden, United Kingdom, identified in a joint study enzymes in honey bees and bumble bees that determine how sensitively they react to different neonicotinoid insecticides. Bayer is convinced the research results will help to selectively develop additional bee-friendly insecticides.

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