Research, Development, Innovation

Bayer Group expenses for research and development increased by 2.7% (Fx adj.) to €1,158 million in the first quarter of 2017, with the Life Science businesses accounting for €1,094 million of this figure (Fx adj. +2.9%).

Research and Development Expenses

 

 

R&D expenses

 

R&D expenses before special items

 

 

Q1 2016

Q1 2017

Change

 

Q1 2016

Q1 2017

Change

 

 

€ million

€ million

Fx adj. %

 

€ million

€ million

Fx adj. %

2016 figures restated

Pharmaceuticals

 

700

712

+0.4

 

667

679

+0.5

Consumer Health

 

58

59

−1.6

 

56

57

−0.7

Crop Science

 

261

283

+5.8

 

261

282

+5.5

Animal Health

 

30

33

+7.7

 

30

33

+7.7

Reconciliation

 

(4)

7

.

 

(4)

7

.

Total Life Sciences

 

1,045

1,094

+2.9

 

1,010

1,058

+3.0

Covestro

 

64

64

.

 

64

64

.

Total Group

 

1,109

1,158

+2.7

 

1,074

1,122

+2.9

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

Relapsed / refractory diffuse large B-cell lymphoma

Renal anemia

Chronic heart failure

Breast cancer with bone metastases

Cancer, various studies

Cancer

Diffuse systemic sclerosis

Cystic fibrosis

Secondary prevention of acute coronary syndrome (ACS)4

Symptomatic uterine fibroids5

Endometriosis

1 As of April 18, 2017
2 Sponsored by Regeneron Pharmaceuticals, Inc.
3 Sponsored by Ionis Pharmaceuticals, Inc.
4 Sponsored by Janssen Research & Development, LLC
5 Based on positive Phase II study data, the decision was taken to initiate Phase III studies.
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 clinical Phase II CAPELLA trial after 28 weeks, our partner Regeneron Pharmaceuticals, Inc., United States, decided to discontinue the further development of rinucumab, a PDGFR-β antibody, in combination with aflibercept (tradename: Eylea™) for the treatment of wet age-related macular degeneration. The trial missed its clinical endpoint, which had been for a statistically significant improvement in visual acuity after 12 or 28 weeks.

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

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

1 As of April 18, 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.

After conducting an interim analysis, the independent Data Monitoring Committee (DMC) issued a recommendation in February 2017 to discontinue the Phase III COMPASS trial as the primary endpoint had been achieved ahead of schedule. The trial investigated the efficacy of rivaroxaban at preventing major adverse cardiac events (MACE) such as cardiovascular mortality, heart attacks and strokes in patients with coronary heart disease or periphery arterial occlusive disease. COMPASS is one of the largest clinical trials investigating rivaroxaban.

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, Japan, U.S.A.: second-line treatment for unresectable liver cancer

Europe: long-term prevention of venous thromboembolic events

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

1 As of April 18, 2017

2 Submitted by Janssen Research & Development, LLC

In January 2017, the United States Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare granted priority review status to regorafenib, an oral multikinase inhibitor, in the registration process for the expansion of indications. If approved, Bayer’s cancer drug will in the future also be available as a second-line treatment to patients with unresectable liver cancer.

In March 2017, Bayer presented the latest results of the EINSTEIN CHOICE trial at the American College of Cardiology’s Annual Scientific Session. The trial found that, in dosages of 10 mg once a day and 20 mg once a day, the oral Factor Xa inhibitor rivaroxaban (Xarelto™) significantly reduced the rate of recurrent venous thromboembolism compared with Aspirin™ (acetylsalicylic acid, ASA) taken once a day in a dosage of 100 mg. The trial investigated patients who had previously received 6 to 12 months of anticoagulant therapy due to them having had a pulmonary embolism or symptomatic deep vein thrombosis. Comparable and low rates of major bleeding (the primary endpoint for safety) that were at the level of the Aspirin™ therapy were observed for both rivaroxaban dosages.

At the end of March 2017, Bayer presented positive data from a Phase II trial involving the oncological development product copanlisib at the American Association for Cancer Research’s Annual Meeting. In the open-label, non-randomized CHRONOS‑1 trial, copanlisib achieved an objective tumor response rate of 59.2% across all patient groups, while the complete response rate stood at 12% and the median duration of response at the time of the primary analysis was more than 98 weeks (687 days). The trial investigated the safety and efficacy of copanlisib in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL), including follicular lymphoma. The patients had previously been treated with at least two other medicines. Copanlisib is an intravenous pan-class I phosphatidylinositol‑3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.

Collaborations

Under an existing exclusive licensing deal, Bayer reached an agreement with Ionis Pharmaceuticals, Inc., United States, in February 2017 pertaining to the further clinical development of IONIS-FXIRx. Under the agreement, Ionis plans to conduct a Phase IIb trial evaluating IONIS-FXIRx in around 200 patients with end-stage kidney disease on hemodialysis to finalize dose selection. Ionis will also initiate development of IONIS-FXI-LRx and plans to develop this substance through Phase I.

Crop Science

In February 2017, we concluded a software cooperation and technology licensing agreement with the fertilizer producer Yara International ASA, Oslo, Norway. The goal of the agreement is to develop new digital farming solutions and increase the use of existing technologies, helping farmers to more efficiently manage their use of fertilizer and crop protection products and thus enhance productivity and sustainability in their operations.