Rivaroxaban
LCM studies program overview
Martin van Eickels MD
Head of Global Medical Affairs Thrombosis
Bayer Healthcare
Continued Success Through
Scientific Endeavour
2013
2008
1993
1990
1975
1899
Rivaroxaban: From Clinical Studies to
Real-World Patients
Phase II studies
Phase III studies
Patients in
LCM study programme
Phase IV studies
IIR projects
Patients treated to date*
*Estimate based on IMS data
To Meet the Needs for Improved Treatments Options
Our R&D Goals
Predictable, once
daily oral
administration
Broad therapeutic
window
Potent
antithrombotic
activity
No routine
coagulation
monitoring
Long-term
anticoagulation
therapy from
hospital to home
Scientific Research Center Bayer Pharma AG
in Wuppertal
The Vision was to Provide Patients with
Improved Anticoagulation Options
A good balance of efficacy and safety
Wide therapeutic window
Oral administration
Fixed dosing regimens
No need for routine coagulation monitoring
Fast onset and offset of action
Low risk of food and drug interactions
Once-daily dosing if possible
Factor Xa: A Key Factor
in the Coagulation Cascade
TF VIIa
Initiation
X
IX
IXa
Xa
Propagation
Inactive factor
II
Prothrombin
Factor Xa –
The gate keeper
IIa
Active factor
Thrombin
Transformation
Catalysis
Adapted from Spyropoulos 2007
Fibrinogen
Fibrin Clot formation
1998
High-Throughput Screening:
5 Promising ‘Lead Structures’
1998
Bayer substance library
200,000 substances screened

1999
Identification of 5 lead compounds
as a starting point for improvement
Preclinical project Factor Xa

Chemical optimization

Discovery of rivaroxaban

In vitro and in vivo animal models
Roehrig et al, 2005; Perzborn et al, 2011
Crystal Structure of Rivaroxaban Revealed
Rivaroxaban
FXa
Tyr228
Roehrig et al, 2005
2002
A Promising Pharmacological
Profile Emerges
Selective, direct Factor Xa inhibitor1
High oral bioavailability2
Rapid onset of action2
Half-life 5–13 hours2-4
66%
metabolized
33%
(unchanged drug)
Limited drug–drug interactions
50%
inactive
metabolites
Dual mode of elimination5
1. Perzborn et al, 2005; 2. Kubitza et al, 2005a; 3. Kubitza et al, 2005b; 4. Kubitza et al, 2008; 5. Weinz et al, 2009
2002
Extensive Phase I
Programme
Phase I programme
Bioavailability/absorption
PK/PD single-dose escalation
Metabolism/excretion
PK/PD multiple-dose escalation
PK/PD in special populations
DDI (PK interactions)







Age
Sex
Body weight
Renal impairment
Hepatic impairment
Ethnicity
Heart failure patients
Other studies


Thrombin generation
Perfusion chamber




CYP3A4/P-gp inhibitors
CYP3A4/P-gp inducers
CYP3A4/P-gp substrates
Ranitidine
DDI (PD interactions)





ASA
Clopidogrel
Enoxaparin
Naproxen
Warfarin (switching from/to)
Early Evidence for Once-Daily Dosing
between rivaroxaban 10 mg and
enoxaparin 40 mg (phase I)1
Inhibition of thrombin generation
Enoxaparin 40 mg
Rivaroxaban 10 mg
3
2
1
0
0
 Lasted
ODIXa-HIP tested 30 mg od after THR
 Efficacy
and safety well within the range
predicted from twice-daily dosing and similar
to enoxaparin (phase II)3
1. Kubitza et al, 2013; Graff et al, 2007; 3. Eriksson et al, 2007
VTE rate (%)
for 24 h after a single dose of
rivaroxaban 30 mg (phase I)2
8
16
24
32
Time (hours)
40
48
30
30
20
20
10
10
0
0 10 20 30* 40 50 60
Total daily dose (mg) of rivaroxaban
*Tested as 30 mg od
Major bleeding rate (%)
 Similar
4
Anti-Factor Xa activity
(change from baseline)
Inhibition of Factor Xa
0
Enoxaparin
40 mg od
The Extensive, Completed Phase III
Studies of Rivaroxaban
Patients with PE
Patients
with AF
Patients with
DVT
Patients at risk of
secondary VTE
Patients
undergoing
major OS
Patients with
medical illness
Patients
with ACS
Rivaroxaban: Worldwide Approvals Across the
Breadth of Indications
VTEx
Pulmonary embolism
Deep vein thrombosis
Approved in 80 countries
SPAF
Ischaemic stroke
Approved in 82 countries
VTEp OS
ACS
Elective hip or knee
replacement surgery
Unstable angina and
myocardial infarction
Approved in 112 countries
Approved in 46 countries
Bayer is Committed to Improving
Thrombosis Management
Registries
N≈97,000
Phase IV/NIS
N≈47,000
Phase IIIb
N≈2,400
Phase II/III
N≈51,000
Completed
Phase I–IIIb
N≈86,000
Over 275,000 patients expected
The Extensive, Ongoing Exploration
of Rivaroxaban
Patients
with PE
Patients
with DVT
Patients
with AF
Patients
with ESUS
Patients at
risk of
secondary
VTE
Patients with
HF and CAD
Paediatric
patients
with VTE
Patients
with ACS
Patients
undergoing
major OS
Patients with
medical illness
Patients with
chronic CAD
or PAD
Patients
with PAD
COMPASS
CAD/PAD Study
Official study title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in
Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using
Anticoagulation StrategieS)
Objective: efficacy and safety of rivaroxaban, low-dose rivaroxaban plus ASA or ASA alone for reducing
risk of MI, stroke or cardiovascular death in CAD or PAD
Rivaroxaban 2.5 mg bid + ASA 100 mg od
± pantoprazole 40 mg od
N~21,000
Population:
Documented CAD
or PAD
R
1:1:1
30-day
washout
period*
Rivaroxaban 5.0 mg bid
± pantoprazole 40 mg od
ASA 100 mg od
± pantoprazole 40 mg od
30-day run-in,
ASA 100 mg
Short design: Randomized, double-blind, controlled
trial
Final
follow-up
visit#
Indication: CAD/PAD
Final
washout
period visit
Start: Q2-13
LPLV: Q1-18
*Patients treated according to local standard of care; #≤30 days of the required pre-specified number of events having occurred
www.clinicaltrials.gov/show/NCT01776424
COMMANDER HF
Chronic HF/CAD Study
Official study title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral
Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Chronic Heart
Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure
Objective: efficacy and safety of rivaroxaban for reducing the risk of MI, stroke or death in HF with CAD
Rivaroxaban 2.5 mg bid (single
or dual antiplatelet therapy)
N=5,000
Population:
HF and CAD after
recent
hospitalization
~6–30 months
R
15–45-day
follow-up
Placebo (single or dual
antiplatelet therapy)
Global treatment
end date*
Short design: Randomized, double-blind, placebocontrolled, parallel-group, multicenter, event-driven,
superiority study
*Date when 984 primary efficacy outcome events have occurred
www.clinicaltrials.gov/ct2/show/NCT01877915
Indication: HF/CAD5
End of
study visit
FPFV: Q3-13
LPLV: Q2-16
EINSTEIN CHOICE
Long-Term Secondary VTE Prevention Study
Official study title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention
of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or
Pulmonary Embolism
Objective: efficacy and safety of reduced-dosed rivaroxaban, standard-dosed rivaroxaban versus ASA for
the long-term secondary prevention of recurrent symptomatic VTE in patients with symptomatic DVT
and/or PE
Rivaroxaban 20 mg od
Population:
DVT and/or PE after
6–12 months of
anticoagulation*
N~2,850
Day 1
R
n~950
Rivaroxaban 10 mg od
n~950
ASA 100 mg od
n~950
12-month treatment duration
Short design: Multicentre, randomized, doubleblind, double-dummy, active-comparator, eventdriven, superiority study
Indication: VTEx
*Completed 6–12 months (±1 month) with interruption of anticoagulation ≤1 week at randomization
www.clinicaltrials.gov/ct2/show/NCT02064439
1 month
observation
period
FPFV: Q1-14
LPLV: Q4-16
Addressing the Unmet Medical Needs…..

In Secondary
Prevention of ACS
rivaroxaban 2.5 mg twice daily in combination with a single
antiplatelet agent, including the novel antiplatelets
 rivaroxaban 2.5 mg twice daily in combination with a single
antiplatelet, a new Phase II study in >2,000 patients with ACS
across >10 countries

in Stroke
Prevention
ESUS accounts for about 25% of ischaemic strokes
 Clinical trials have addressed secondary prevention for all major
types of ischaemic stroke except ESUS
 High likelihood that anticoagulants would be effective for
secondary stroke prevention in patients with ESUS

In PAD
The PAD POST INTERVENTION Study
 Exploring the benefits of rivaroxaban in reducing thrombotic
vascular complications in moderate to high risk patients
undergoing either peripheral artery bypass graft or percutaneous
peripheral artery interventions
LCM
Phase IV + NIS Programme Overview
Study
Indication
Objective
FPFV/
LPLV
ACSsp
Rivaroxaban plus dual antiplatelet therapy vs UFH during
elective PCI (N=107)1
Q4-11
Q1-13
SPAF
Efficacy and safety of rivaroxaban for prevention of CV events in
Q4-12
non-valvular AF patients undergoing cardioversion vs VKA
Q1-14
(N=1,504)2
SPAF
Efficacy of rivaroxaban for LA thrombus resolution in nonvalvular AF/flutter patients (N~60)3
Q3-13
Q2-15*
SPAF
Safety of uninterrupted rivaroxaban vs VKA in non-valvular AF
patients undergoing catheter ablation (N~250)4
Q1-13
Q4-14*
SPAF/
ACSsp
Safety of two rivaroxaban regimens vs VKA after PCI in nonvalvular AF patients (N~2,100)5
Q2-13
Q2-15*
VTEp OS
Safety and efficacy of rivaroxaban vs SOC in VTE prophylaxis
after major orthopaedic surgery (N=17,701)6
Q1-09
Q4-12
VTEx
Safety of rivaroxaban vs SOC for acute DVT treatment
(N=4,800)7
Q2-12
Q1-15*
SPAF
Safety of rivaroxaban for stroke prevention in
non-valvular AF. Region: Europe (N=6,000)8
Q2-12
EU:
Q4-14*
*Subject to change. Abbreviations and details of studies on www.clinicaltrials.gov are found in slide notes
X-PLORER
PCI Study
Official study title: Prospective, Multi-center, Randomized, Heparin-controlled Dose-finding Trial to Evaluate the Efficacy
and Safety of Rivaroxaban, a Direct Factor Xa Inhibitor, on the Background of Standard Dual Antiplatelet Therapy to
Support Elective Percutaneous Coronary Intervention
Objective: compare rivaroxaban with UFH therapy, on a background of dual antiplatelet therapy, for
suppression of thrombosis and related ischaemic events during elective PCI
Rivaroxaban 20 mg*
N=107
Population:
Symptomatic CAD
undergoing elective PCI‡
Index
PCI
Rivaroxaban 10 mg*
R
Rivaroxaban 10 mg* plus
UFH 50 IU/kg bolus#
30 + 7 days
2:2:2:1
UFH 70–100 IU/kg
bolus#
Follow-up
Short design: Prospective, randomized, semiblinded study
Indication: SPAF
FPFV: Q4-11
LPLV: Q1-13
*Single dose 2–4 hours before index PCI procedure; #5 minutes before PCI (after catheter sheath insertion) to end of PCI;
‡All patients on stable dual antiplatelet therapy ≥5 days before PCI
www.clinicaltrials.gov/ct2/show/NCT01442792
RIVAROXABAN AT THE DOSES TESTED, EFFECTIVELY SUPPRESSED THROMBIN GENERATION
AND AMPLIFICATION UPON BALLOON DILATATION AND STENTING.
A rebound phenomenon was noticed in the heparin (only) group, but not with rivaroxaban.
10
0.4
0.3
0.2
0.1
0.0
1-5
start 0.5 hrs 2 hrs 6-8 hrs 48 hrs
days
PCI
TAT complex (mcg/L)
F1+2 (nmol/L)
Median vs. time curves plotted by individual treatment for median anti-Xa activity, pro-thrombin time, activated
partial thromboplastin time, endogenous thrombin potential per treatment.
8
6
4
2
0
1-5
days
20 mg
10 mg + UFH
10 mg
UFH
2.0
20.0
1.5
15.0
PT (seconds)
Anti-Xa (U/mL)
PCI
prior
prior
10 mg
start 0.5 hrs 2 hrs 6-8 hrs 48 hrs
1.0
0.5
0.0
20 mg
10 mg + UFH
UFH
10.0
5.0
0.0
1-5
start
days
PCI
0.5 hrs 2 hrs 6-8 hrs 48 hrs
days
prior
10 mg
1-5
start 0.5 hrs 2 hrs 6-8 hrs 48 hrs
PCI
prior
20 mg
10 mg + UFH
UFH
10 mg
20 mg
10 mg + UFH
FOR PRESENTATION PURPOSES ONLY. DO NOT DISTRIBUTE.
UFH
The results of Xplorer contrast with these of the Randomized, Open-label, DoseRanging study of Dabigatran Etexilate, a Novel, Oral, Direct Thrombin-inhibitor in
clinical development, in Elective Percutaneous Coronary Intervention (D-fine)
study.
Vranckx P et al. Eurointervention 2013.
Numerically, there were fewer thrombotic events and less bleeding
complications with rivaroxaban. Major bleeding events did not occur in
any treatment group.
Overall the trial was too small to draw any conclusion regarding differences in clinical outcome.
Rivaroxaban
10mg
Rivaroxaban
Rivaroxaban
20mg
10 or 20mg
Rivaroxaban
10mg plus
heparin
Heparin
(n:32)
(n:62)
(n:29)
0 (0)
0 (0)
0 (0)
0 (0)
1 (6.25)
0 (0)
3 (9.4)
3 (4.8)
4 (13.8)
5 (31.3)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
4 (13.3)
1 (3.1)
5(8.1)
5 (17.2)
4 (25.0)
3 (10.0)
1 (3.1)
4 (6.5)
4 (13.8)
3 (18.8)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
(n:16)
(n:30 )
Bailout AC therapy and/or flow
limiting thrombotic event*
MYOCARDIAL INFARCTION
Peri-procedural
Spontaneous, up to 30 days
BLEEDING
TIMI_class
Significant (major or minor)
Requiring medical attention
BARC_class
2, 3 or 5
3 or 5
AC denotes anticoagulation therapy. TIMI denotes Thrombolysis In Myocardial Infarction, ARC denotes academic research consortium, ND denotes not
done
X-VERT
Cardioversion Study
Official study title: A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring
the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral
Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation
Scheduled for Cardioversion
Yes: direct
cardioversion
R
Sufficient anticoagulation
or
immediate
TEE
1–5
days
2:1
VKA (INR 2–3)
N=1,500
No: delayed
cardioversion
Rivaroxaban
20 mg od*
R
≥21 days
(max. 56 days)
2:1
VKA (INR 2–3)
Short design: Prospective, randomized, open-label,
blinded endpoint evaluation, parallel-group, active
controlled, multi-center study
Indication: SPAF
*CrCl 30–49 ml/min: 15 mg od
http://www.clinicaltrials.gov/ct2/show/NCT01674647 Ezekowitz MD et al. Am Heart J 2014
Cardioversion
Population:
Non-valvular AF
lasting >48 hours or
unknown duration,
scheduled for
cardioversion
(electrical or
pharmacological)
Rivaroxaban
20 mg od*
Cardioversion
Objective: efficacy and safety of rivaroxaban versus VKA for prevention of cardiovascular events in AF
patients scheduled for cardioversion
Rivaroxaban
20 mg od*
SOC
42 days
30-day
follow-up
VKA (INR 2–3)
SOC
Rivaroxaban
20 mg od*
SOC
42 days
30-day
follow-up
VKA (INR 2–3)
SOC
FPFV: Q4-12
LPLV: Q1-14
Time to cardioversion by cardioversion strategy
Median time to cardioversion
100
Days
80
p<0.001
60
p=0.628
40
22
days
20
30
days
Patients (%)
Rivaroxaban
VKA
Patients cardioverted as scheduled*
100
Rivaroxaban
VKA
80
77.0 p<0.001
60
1 patient with
inadequate
anticoagulation
40
36.3
20
95 patients with
inadequate
anticoagulation
0
0
Early
Delayed
Delayed group
*Reason for not performing cardioversion as first scheduled from 21–25 days primarily due to
inadequate anticoagulation (indicated by drug compliance <80% for rivaroxaban or weekly INRs outside
the range of 2.0–3.0 for 3 consecutive weeks before cardioversion for VKA)
X-TRA
LA/LAA Thrombus Resolution Study
Official study title: An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral
Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular
Atrial Fibrillation or Atrial Flutter
Objective: efficacy of rivaroxaban for resolution of LA/LAA thrombus (confirmed by TEE) in non-valvular
AF or atrial flutter
Rivaroxaban 20 mg od*
Population:
Non-valvular AF or atrial
flutter with LA/LAA
thrombus detected
via TEE
Standard of care
N~60
6 weeks
Treatment
assignment
(baseline data)
Short design: Single arm, multicenter, prospective,
open-label, interventional study
*CrCl 15–49 ml/min: 15 mg od
www.clinicaltrials.gov/show/NCT01839357
30 days
End-of-treatment
TEE
Indication: SPAF
FPFV: Q3-13
LPLV: Q2-15
End of
follow-up
VENTURE-AF
Catheter Ablation Study
Official study title: A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted
Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation
Rivaroxaban
20 mg od
N~25,013
Population:
Paroxysmal or persistent
non-valvular AF, first ever
catheter ablation
R
≥28 days
1:1
VKA (INR 2–3)
Day 1
Short design: Randomized, open-label, activecontrolled, multicenter study
www.clinicaltrials.gov/ct2/show/NCT01729871
Catheter ablation procedure:
Intravenous heparin (target
ACT = 300–400 seconds)
Objective: safety of rivaroxaban versus VKA in AF patients undergoing catheter ablation
≥4 weeks
Indication: SPAF
Rivaroxaban
20 mg od
30±5 days
follow-up
VKA (INR 2–3)
≥8 weeks
FPFV: Q1-13
LPLV: Q4-14
PIONEER AF-PCI
PCI Study
Official study title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of
Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who
Undergo Percutaneous Coronary Intervention
Objective: safety of two rivaroxaban regimens versus VKA after PCI (with stent placement) in non-valvular
AF
Rivaroxaban 15 mg od*# + clopidogrel
Population:
Paroxysmal, persistent
or permanent AF,
undergoing PCI
(with stent placement)
N=2,100
Rivaroxaban 2.5 mg bid#
+ DAPT‡
Rivaroxaban 15 mg od*
+ low-dose ASA
R
1:1:1
Intended DAPT duration
of 1, 6 or 12 months
VKA (INR 2.0–3.0)§
+ DAPT‡
Short design: Open-label, randomized, multicenter
study
VKA + low-dose ASA
End of treatment
(12 months)
Indication: SPAF/ACS
FPFV: Q2-13
LPLV: Q2-15
*CrCl 30–49 ml/min: 10 mg od; #first dose 72–96 hours after sheath removal; ‡ASA (75–100 mg daily) + clopidogrel (75 mg daily)
(alternative use of prasugrel or ticagrelor allowed, but capped at 15%); §first dose 12–72 hours after sheath removal
www.clinicaltrials.gov/ct2/show/NCT01830543
Bayer is Committed to Improving
Thrombosis Management
Registries
N≈97,000
Phase IV/NIS
N≈47,000
Phase IIIb
N≈2,400
Phase II/III
N≈51,000
Completed
Phase I–IIIb
N≈86,000
Over 275,000 patients expected
Clinical Trials vs Real-Life Experience
Clinical study

Strict inclusion and exclusion criteria
 Strict study protocol
 Objectively adjudicated event rates
 Strict guidance for problematic cases
Real life

Only indications and contra-indications
regulated
 Dose recommendations for groups
of patients only
 Over- and under-representation of events
 Limited guidance for problematic cases
Capturing Real-Life Experience with
Rivaroxaban/Novel OACs
Non-interventional studies
I and II (US)
Bayer/Janssen
support
(Europe)
Dresden
NOAC
(Dresden, Germany)
Global AF registry
Results of RECORD Studies
Confirmed in Real-Life Practice
Incidence (%)
2.0
10.0
8.0
1.5
1.3
7.0
Rivaroxaban
Enoxaparin
SOC
6.5
6.0
1.0 4.7
1.0
4.0
0.6
2.2
0.5
2.0
0.4 0.2
0.0
3.2
0.6
1.8
1.7 1.4
0.4 0.3
Major
Major
Any bleeding¹
Major
Major
Any bleeding²
Symptomatic
VTE¹
Symptomatic
VTE²
bleeding
bleeding
bleeding
bleeding
(RECORD)¹
(EMA)¹
(RECORD)²
(EMA)²
Different treatment durations in RECORD and XAMOS; all events treatment emergent. SOC, standard of care (82% LMWH)
1. Turpie et al, 2011; 2. Turpie et al, 2013
GARFIELD...Uptake of Novel OACs
VKA, Vitamin K antagonists; FXa, Factor Xa inhibitors; DTI, Direct thrombin inhibitors; AP, Antiplatelets
Bayer is Committed to Improving
Thrombosis Management
Registries
N≈97,000
Phase IV/NIS
N≈47,000
Phase IIIb
N≈2,400
Phase II/III
N≈51,000
Completed
Phase I–IIIb
N≈86,000
Over 275,000 patients expected
Global Clinical IIR Status:
100 IIRs with Rivaroxaban Ongoing*
Others
20
Device surgery
Worldwide IIR network
1
ACS/atherosclerosis
Europe
43
1
VTEp
Americas
13
5
VTEx
Asia
38
15
SPAF
58
Multinational
6
All
100
0
*Status Oct 2014 based on IMPACT
20
40
60
80
100 120
Responsible Use is Crucial
The basics
Right dose for the
Right patient for the
Right indication
Practical questions
Concomitant medications
Transition to and from ‘Xarelto’
Management of bleeding
To Meet the Needs for Improved Treatments Options
Our R&D Goals
Predictable, once
daily oral
administration
Potent
antithrombotic
activity
Scientific Research Continues in BAYER
Broad therapeutic
window
No routine
coagulation
monitoring
Long-term
anticoagulation
therapy from
hospital to home
Research in Indications with High
Unmet Medical Needs
Cardiology research covers diseases in:
Blood
Lung
Heart
Kidney
Thrombosis
Pulmonary hypertension
Heart failure
Chronic kidney disease
Increased blood pressure
in lung vessels leading to
lung dysfunction and right
heart insufficiency
The heart fails to pump
blood at a sufficient rate
to meet the metabolic
requirements of the body
Impaired kidney function
due to damage to fine
capillaries in the glomeruli
Development of arterial or
venous thrombi preventing
blood flow in vessels
Anaemia
Decreased erythropoiesis
in chronic kidney disease
Development Pipeline
Phase I (14)
Cardiovascular
Phase III (16)
Phase II (14)
Cancer
Roniciclib (BAY 1000394)
(CDK-Inhibitor)
Heart Failure
BAY 86-8050
(Vasopr. Rec. Antag.)
Diabetic Nephropathy
Finerenone
(MR-Antagonist)
Heart Failure
BAY 1067197
(Part. Aden. A1 Agonist)
Skin and Lung Infections
Tedizolid
Cancer
Anetumab ravtansine
(BAY 94-9343)
(Mesothelin-ADC)
Cancer
BAY 1125976
Allosteric AKT 1/2 - I.
CHF
Finerenone (BAY 94-8862)
(MR-Antagonist)
Additional Indications
Sorafenib
Hemophilia
Damoctocog alfa pegol
(BAY 94-9027)
(peg rFVIII mutein)
Sympt. Uterine Fibroids
BAY 1002670
(S-PRAnt)
Cancer
BAY 1143572
PTEFb Inhibitor
NHL
Copanlisib (BAY 80-6946)
(PI3k Inhibitor)
Cancer
BAY 2010112
PSMA BiTE Antibody.
Cancer
Bronchiectasis
BAY 85-8501
Neutroph. Elastase Inhibit.
Cancer
BAY 1179470
FGFR2 Ab
Contraception
BAY1007626
(Progestin IUS)
Cancer
Heart failure
BAY 1142524
Chymase Inhibitor
Lung disease
BAY 1097761
PEGylated Adrenomedullin
Worsening chronic heart failure
Vericiguat (BAY 1021189)
(sGC Stimulator)
Endometriose
BAY 98-7196
Intravaginal ring
Cancer
BAY1163877
Pan-FGFR Inhibitor
Anemia
Molidustat (BAY 85-3934
(HIF-PH Inhibitor)
BAY1082439
(PI3k Inhibitor)
Refametinib
(BAY 86-9766)
Cancer
Regorafenib
Combination study in CRPC
Radium-223-Dichloride
Regorafenib
Gram-negative Pneumonia
Amikacin inhale
Breast Cancer
Sorafenib
PH.IIP
MACE prevention
Riociguat (sGC Stimulator)
Rivaroxaban
Adjuvant RCC
Sorafenib
Diffuse Systemic sclerosis
CHF and CAD
Riociguat (sGC Stimulator)
Rivaroxaban
Raynaud's phenomenon
Riociguat (sGC Stimulator)
Long-term VTE prevention
Rivaroxaban
Contraception
LCS 16
Cancer
Medically ill
Non-CF Bronchiectasis
Radium-223-Dichlorid
Rivaroxaban
Cipro DPI
HCC 2nd line
RESPITE study (insuff.
responders to PDE5-inhib.)
Regorafenib
Status April 2014
Selection of major Pharma pipeline projects
in clinical Phase I to III
Adjuvant CRC with resected liver
metastases
*Regorafenib is a Bayer compound developed solely by Bayer. In 2011,
Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under
which Onyx will receive a royalty on any future global net sales of
regorafenib in oncology
http://pharmatoday.bhc.cnb/APPS/BSP/DE/BSP-GPM/BSP-GPM.nsf/id/EN_Pipeline_external
VV Atrophy
Prasterone
(Vaginorm)
Riociguat
New molecular entities
(NME)
Life cycle management
(LCM)
Thank you very much
for your attention