Management Report

9.1 HealthCare

Research and development

Expenses for research and development at HealthCare rose by 18.4% (Fx adj.) in the first half of 2015 to €1,296 million (h1 2014: €1,052 million), including €678 million (Fx adj. +22.3%) in the second quarter (q2 2014: €530 million). We made further progress with our research and development pipeline in the second quarter of 2015.

The most important drug candidates in the approval process are:

Products Submitted for Approval1[Table 19]
AfliberceptE.U.; treatment of myopic choroidal neovascularization (mCNV)
Bay 81-8973 (rFVIII)E.U., U.S.A., Japan; treatment of hemophilia A
Rivaroxaban2U.S.A.; secondary prophylaxis of acute coronary syndrome (ACS)
Rivaroxaban Japan;  treatment of deep vein thrombosis and pulmonary embolism, prevention of recurrent venous thromboembolism
1 as of July 16, 2015
submitted by Janssen Research & Development, LLC

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 [Table 20]
  Indication Status
Amikacin Inhale Pulmonary infection 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
LCS-16 (ULD LNG Contraceptive System) Intrauterine contraception, duration of use:
up to 5 years
Phase III
ODM-201 (AR antagonist) Prostate cancer 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 infection3 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 98-7196 (intravaginal ring) Endometriosis Phase II
Copanlisib (PI3K inhibitor) Recurrent/resistant non-Hodgkin’s lymphoma (NHL) Phase II
Finerenone (MR antagonist) Chronic heart failure Phase II
Finerenone (MR antagonist) Diabetic nephropathy Phase II
Molidustat (HIF-PH inhibitor) Anemia Phase II
Radium-223 dichloride Bone metastases in cancer 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) Uterine fibroids Phase II
Vilaprisan (S-PRM) Endometriosis Phase II
1 as of July 16, 2015
2 sponsored by Janssen Research & Development, LLC
3 Phase III for the treatment of complicated skin infections is completed; first submissions have been made
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.

We have expanded our global clinical development program for the cancer drug copanlisib to include new studies. A Phase iii and a Phase ii trial began enrolling patients in May 2015, while a further Phase iii study started in June 2015. The new studies are designed to investigate the safety and efficacy of copanlisib in patients with recurring indolent non-Hodgkin’s lymphoma (nhl) and diffuse large B-cell lymphomas (dlbcl), an aggressive subtype of nhl. Copanlisib is a novel, intravenous phosphatidylinositol 3-kinase (pi3k) inhibitor.

In April 2015, we submitted an application to the Japanese Ministry of Health, Labour and Welfare (mhlw) for marketing authorization for radium-223 dichloride as an injection solution for the treatment of prostate carcinoma with bone metastases. Radium-223 dichloride is approved in more than 40 countries worldwide under the brand name XofigoTM.

In May 2015, the oral anticoagulant XareltoTM (active ingredient: rivaroxaban) was approved by the China Food and Drug Administration (cfda) for the prevention of stroke and systemic embolism in patients with atrial fibrillation and for the treatment of deep vein thrombosis (dvt). The approval also includes the use of XareltoTM to reduce the risk of recurrent dvt and pulmonary embolism following acute dvt.

In June 2015, the Japanese mhlw approved EyleaTM (active ingredient: aflibercept for injection into the eye) to treat patients with macular edema secondary to retinal vein occlusion (rvo). This new approval includes branch retinal vein occlusion (brvo) in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion (crvo).

In June 2015, we submitted an application to the Japanese mhlw for marketing authorization for the recombinant Factor viii compound bay 81-8973 for the treatment of hemophilia a.

A Phase IIa clinical study with regorafenib eye drops did not show the desired results and the project is therefore being discontinued. The study investigated the use of regorafenib for the treatment of wet age-related macular degeneration (AMD).

Capital expenditures, acquisitions and cooperations

In April 2015, we entered into an exclusive license agreement with Isis Pharmaceuticals, Inc., United States, pertaining to isis–FXIRX, an antisense drug in clinical development for the prevention of thrombosis. Under the agreement, Bayer will further develop and commercialize isis-FXIRX in areas of high unmet medical need. Antisense drugs bind to the target mRNA molecules in the cell and inhibit the production of disease-causing proteins. The novel mechanism of inhibiting Factor xi synthesis through isis-FXIRX may offer a treatment option for patients for whom none is currently available.

In June 2015, we entered into a strategic research alliance with Johns Hopkins University, United States, concerning the discovery and development of innovative drugs for the treatment of serious diseases of the posterior part of the eye that affect many people worldwide. The five-year collaboration will aim to develop new ophthalmic therapies for various retinal diseases.

Emerging Markets

HealthCare raised sales in the Emerging Markets by 16.2% (Fx adj.) in the first half of 2015 to €3,603 million (h1 2014: €2,989 million), including €1,824 million (Fx adj. +15.0%) in the second quarter of 2015 (q2 2014: €1,544 million). The largest increase in absolute terms in the second 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 and Eastern Europe. The Emerging Markets’ share of total HealthCare sales was 31.6% in the first half of 2015 (h1 201433.3%) and 30.9% in the second quarter (q2 201433.5%).

Last updated: July 29, 2015  Copyright © Bayer AG