Management Report

9.1 HealthCare

Research and development

Expenses for research and development at HealthCare rose by 14.7% (Fx adj.) in the first quarter of 2015 to €628 million (q1 2014: €530 million). We made further progress with our research and development pipeline.

The most important drug candidates in the approval process are:

Products Submitted for Approval1 [Table 19]

Japan; treatment of macular edema secondary to branch retinal vein occlusion (BRVO)
Aflibercept E.U., treatment of myopic choroidal neovascularization (mCNV)
Bay 81-8973 E.U., U.S.A.; treatment of hemophilia A
Rivaroxaban2 U.S.A.; secondary prophylaxis of acute coronary syndrome (ACS)

Japan; treatment of deep vein thrombosis and pulmonary embolism, prevention of recurrent venous thromboembolism
1 as of April 16, 2015
2 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
  Indication Status
Amikacin Inhale Treatment of pulmonary infection Phase III
Damoctocog alfa pegol (BAY 94-9027, long-acting rFVIII) Treatment of hemophilia A
Phase III
Ciprofloxacin DPI Treatment of pulmonary infection Phase III
Copanlisib (PI3K inhibitor)
Treatment of 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) Treatment of prostate cancer Phase III
Radium-223 dichloride
Combination treatment of castration-resistant prostate cancer Phase III
Regorafenib Treatment of refractory liver cancer Phase III
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
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
Sorafenib Treatment of kidney cancer, adjuvant therapy Phase III
Tedizolid Treatment of pulmonary infection3 Phase III
Anetumab ravtansine (Mesothelin ADC) Cancer therapy
Phase II
BAY 1067197 (partial adenosine A1 agonist) Heart failure
Phase II
BAY 98-7196 (intravaginal ring) Endometriosis Phase II
Copanlisib (PI3K inhibitor) Treatment of recurrent/resistant non-Hodgkin’s lymphoma 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 Treatment of bone metastases in cancer Phase II
Refametinib (MEK inhibitor) Cancer therapy Phase II
Regorafenib Cancer therapy Phase II
Regorafenib (ophthalmology) Treatment of wet age-related macular degeneration (AMD) 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) Treatment of small-cell lung cancer (SCLC) Phase II
Sorafenib Cancer therapy Phase II
Vericiguat (BAY 1021189, sGC stimulator) Chronic heart failure
Phase II
Vilaprisan (S-PRM) Treatment of uterine fibroids Phase II
Vilaprisan (S-PRM) Endometriosis Phase II
1 as of April 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.

In February 2015, AdempasTM (active ingredient: riociguat) received marketing authorization from the Japanese Ministry of Health, Labor and Welfare (mhlw) for treatment of patients with pulmonary arterial hypertension (pah). Following its approval in Japan in January 2014 for the treatment of inoperable chronic thromboembolic pulmonary hypertension (cteph) or persistent or recurrent cteph after surgery, AdempasTM is now the first drug approved in Japan to treat two forms of pulmonary hypertension. The development and commercialization of riociguat is part of the global strategic pharmaceutical collaboration with Merck & Co., Inc., United States, in the field of soluble guanylate cyclase (sGC) modulation.

In February 2015, the European Commission extended marketing authorization for EyleaTM (active ingredient: aflibercept for injection into the eye) to include the treatment of patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (brvo). Together with the indication approved some time ago for central retinal vein occlusion (crvo), EyleaTM can now be used in Europe by all patients with visual impairment due to macular edema resulting from retinal vein occlusion (rvo). Furthermore, in March 2015 we submitted an application to the European Medicines Agency (ema) for marketing authorization of aflibercept for the treatment of myopic choroidal neovascularization (mCNV).

In March 2015, we suspended enrollment in a Phase iii trial with regorafenib (trade name: StivargaTM) due to insufficient patient recruitment. Due to the low number of trial participants, it will not be possible to assess the study endpoints. The trial is investigating regorafenib as an adjuvant treatment option for colorectal cancer following resection of liver metastases with curative intent.

In April 2015, we announced the expansion of our global clinical development program for researching the cancer drug copanlisib. Various therapeutic options for different forms of non-Hodgkin’s lymphoma (nhl) are to be investigated in two Phase iii trials and a Phase ii trial. The new trials are provisionally scheduled to begin recruiting patients in mid-2015 and investigating the safety and effectiveness of copanlisib in patients with recurring indolent nhl and diffuse large B-cell lymphomas (dlbcl), an aggressive subtype of nhl.

In January 2015, GadovistTM (active ingredient: gadobutrol) was approved in the United States as the first contrast agent in magnetic resonance imaging (mri) for use in children under two years of age. In March 2015, we received approval in Japan for GadovistTM injection for use with mri. GadovistTM is thus the first high concentration/high relaxivity gadolinium-based contrast agent to be made available in Japan.

Capital expenditures, acquisitions and cooperations

In March 2015, we expanded our partnership with the Broad Institute at the Massachusetts Institute of Technology (mit) and Harvard University to include collaboration on cardiovascular genomics and drug discovery.

Emerging Markets

HealthCare raised sales in the Emerging Markets by 17.4% in the first quarter of 2015 to €1,823 million (q1 2014: €1,479 million). The largest increase in absolute terms was recorded in China. In addition to the positive development of our pharmaceutical products, we especially benefited from the acquired consumer care businesses. We lifted sales in both segments in Russia as well. Business in Latin America developed positively, primarily in the Consumer Care Division. The Emerging Markets accounted for 31.7% (q1 2014: 32.3%) of total HealthCare sales.

Last updated: August 16, 2017  Copyright © Bayer AG