Growth and Innovation
HealthCare

Research and Development

Expenses for research and development at HealthCare rose by 19.4% (Fx adj.) in the first nine months of 2015 to €1,995 million (9M 2014: €1,613 million), including €699 million (Fx adj. +21.0%) in the third quarter (Q3 2014: €561 million). We made further progress with our research and development pipeline in the third quarter of 2015.

The most important drug candidates in the approval process are:

Products Submitted for Approval1

 

 

 

 

 

Indication

1

As of October 22, 2015

2

Submitted by Janssen Research & Development, LLC

Aflibercept

 

E.U.; treatment of myopic choroidal neovascularization (mCNV)

Bay 81-8973 (rFVIII)

 

E.U., U.S.A., Japan; treatment of hemophilia A

Rivaroxaban2

 

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

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

Research and Development Projects (Phases II and III)1

 

 

 

 

 

 

 

Indication

 

Status

1

As of October 22, 2015

2

Sponsored by Janssen Research & Development, LLC

3

Sponsored by Isis 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 pre-defined 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.

Amikacin Inhale

 

Pulmonary infection

 

Phase III

BAY 1841788 (ODM-201, AR antagonist)

 

Prostate cancer

 

Phase III

Damoctocog alfa pegol (BAY 94-9027, long-acting rFVIII)

 

Hemophilia A

 

Phase III

Ciprofloxacin DPI

 

Pulmonary infection

 

Phase III

Copanlisib (PI3K inhibitor)

 

Various forms of non-Hodgkin’s lymphoma (NHL)

 

Phase III

Finerenone (MR antagonist)

 

Chronic heart failure

 

Phase III

Finerenone (MR antagonist)

 

Diabetic kidney disease

 

Phase III

LCS-16 (ULD LNG Contraceptive System)

 

Contraception, duration of use: up to 5 years

 

Phase III

Radium-223 dichloride

 

Combination treatment of castration-resistant prostate cancer

 

Phase III

Regorafenib

 

Refractory liver cancer

 

Phase III

Riociguat

 

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

 

Phase III

Rivaroxaban

 

Prevention of major adverse cardiac events (MACE)

 

Phase III

Rivaroxaban

 

Anti-coagulation in patients with chronic heart failure2

 

Phase III

Rivaroxaban

 

Long-term prevention of venous thromboembolism

 

Phase III

Rivaroxaban

 

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

 

Phase III

Rivaroxaban

 

Embolic stroke of undetermined source (ESUS)

 

Phase III

Rivaroxaban

 

Peripheral artery disease (PAD)

 

Phase III

Tedizolid

 

Pulmonary infection

 

Phase III

Anetumab ravtansine (Mesothelin ADC)

 

Cancer

 

Phase II

BAY 1067197 (partial adenosine A1 agonist)

 

Heart failure

 

Phase II

BAY 1007626 (progestine IUS)

 

Contraception

 

Phase II

BAY 1142524 (Chymase inhibitor)

 

Heart failure

 

Phase II

BAY 2306001 (ISIS-FXIRx)

 

Prevention of thrombosis3

 

Phase II

BAY 98-7196 + anastrozole (intravaginal ring)

 

Endometriosis

 

Phase II

Copanlisib (PI3K inhibitor)

 

Recurrent / resistant non-Hodgkin’s lymphoma (NHL)

 

Phase II

Molidustat (HIF-PH inhibitor)

 

Renal anemia

 

Phase II

PDGRF-beta + aflibercept

 

Wet age-related macular degeneration4

 

Phase II

Radium-223 dichloride

 

Bone metastases in breast cancer

 

Phase II

Radium-223 dichloride

 

Cancer, various studies

 

Phase II

Refametinib (MEK inhibitor)

 

Cancer

 

Phase II

Regorafenib

 

Cancer

 

Phase II

Riociguat

 

Pulmonary hypertension (IIP)

 

Phase II

Riociguat

 

Raynaud’s phenomenon

 

Phase II

Riociguat

 

Diffuse systemic sclerosis

 

Phase II

Riociguat

 

Cystic fibrosis

 

Phase II

Rivaroxaban

 

Secondary prevention of acute coronary syndrome (ACS)2

 

Phase II

Roniciclib (CDK inhibitor)

 

Small-cell lung cancer (SCLC)

 

Phase II

Vericiguat (BAY 1021189, sGC stimulator)

 

Chronic heart failure

 

Phase II

Vilaprisan (S-PRM)

 

Symptomatic uterine fibroids

 

Phase II

Vilaprisan (S-PRM)

 

Endometriosis

 

Phase II

In July 2015, Gadovist™ was approved by the European Commission for use in children under two years of age. This label extension applies to all indications that have already been approved.

Since August 2015, our innovative immunostimulant Zelnate™ has been available in the United States. It was approved by the United States Department of Agriculture (USDA) to aid in the treatment of bovine respiratory disease caused by Mannheimia haemolytica bacteria. The product offers veterinarians and farmers a new approach alongside vaccinations and antibiotics for treating these complex infectious diseases, which have a substantial negative impact in cattle breeding.

In September 2015, the oral anticoagulant Xarelto™ (active ingredient: rivaroxaban) was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment and secondary prevention of pulmonary embolism and deep vein thrombosis.

In September 2015, the European Committee for Medicinal Products for Human Use (CHMP) recommended the approval of aflibercept for injection into the eye (tradename: Eylea™) for the treatment of myopic choroidal neovascularization (mCNV).

We are expanding the clinical development program for finerenone, our novel, oral, third-generation mineralocorticoid receptor antagonist, to include three new Phase III trials. In September 2015, two trials were initiated to investigate the efficacy and safety of finerenone in patients with diabetic kidney disease. Another Phase III trial is being prepared in the indication chronic heart failure.

Capital Expenditures, Acquisitions and Cooperations

In July 2015, we entered into a collaboration and license agreement with Sprint Bioscience AB, Sweden, concerning the research, development and commercialization of oncological drug candidates. Under the agreement, we will receive the license for a research program that is currently at the preclinical stage and aims at inhibiting tumor cell metabolism.

Emerging Markets

HealthCare raised sales in the Emerging Markets by 15.6% (Fx adj.) in the first nine months of 2015 to €5,352 million (9M 2014: €4,582 million), including €1,749 million (Fx adj. +14.6%) in the third quarter (Q3 2014: €1,593 million). The largest increase in absolute terms in the third quarter was recorded in China, where, in addition to the positive development of our pharmaceutical products, we especially benefited from the acquired consumer care businesses. We posted double-digit sales growth in Latin America. The Emerging Markets’ share of total HealthCare sales was 31.4% in the first nine months of 2015 (9M 2014: 33.4%) and 31.0% in the third quarter (Q3 2014: 33.6%).