Rivaroxaban LCM studies program overview Martin van Eickels MD Head of Global Medical Affairs...

Rivaroxaban LCM studies program overview

Martin van Eickels MDHead of Global Medical Affairs Thrombosis

Bayer Healthcare

1993

2008

Continued Success Through Scientific Endeavour

1975

1899

1990

2013

Rivaroxaban: From Clinical Studies to Real-World Patients

Phase II studies

Phase IV studies

IIR projects

Phase III studies

Patients inLCM study programme

Patients treated to date*

*Estimate based on IMS data

100Over 10 million

Over 275,000

6

11

7

To Meet the Needs for Improved Treatments Options

Predictable, once daily oral

administration

Potent antithrombotic

activity

No routine coagulation monitoring

Broad therapeutic window

Long-term anticoagulation

therapy from hospital to home

Our R&D Goals

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

No need for routine coagulation monitoring

Wide therapeutic window

Oral administration

Fixed dosing regimens

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

Adapted from Spyropoulos 2007

Inactive factor

Active factor

Transformation

Catalysis

Propagation

Clot formationFibrinogen Fibrin

Thrombin

Prothrombin

X IX

Xa IXa

II

IIa

TFInitiation

VIIa

Factor Xa – The gate keeper

High-Throughput Screening: 5 Promising ‘Lead Structures’

Roehrig et al, 2005; Perzborn et al, 2011

1998

1998 Bayer substance library

200,000 substances screened

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

1999

Crystal Structure of Rivaroxaban Revealed

FXa

Rivaroxaban

Tyr228

Roehrig et al, 2005

A Promising Pharmacological Profile Emerges

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

Selective, direct Factor Xa inhibitor1

High oral bioavailability2

Rapid onset of action2

Half-life 5–13 hours2-4

Dual mode of elimination5

Limited drug–drug interactions

33%(unchanged drug)

50%inactive

metabolites

66%metabolized

2002

Extensive Phase I Programme

Bioavailability/absorption

PK/PD multiple-dose escalationMetabolism/excretion

PK/PD single-dose escalation

Phase I programme

Age Sex Body weight Renal impairment Hepatic impairment Ethnicity Heart failure patients

PK/PD in special populations

Thrombin generation Perfusion chamber

Other studies

CYP3A4/P-gp inhibitors CYP3A4/P-gp inducers CYP3A4/P-gp substrates Ranitidine

DDI (PK interactions)

ASA Clopidogrel Enoxaparin Naproxen Warfarin (switching from/to)

DDI (PD interactions)

2002

Early Evidence for Once-Daily Dosing

1. Kubitza et al, 2013; Graff et al, 2007; 3. Eriksson et al, 2007

Inhibition of Factor Xa

Similar between rivaroxaban 10 mg and enoxaparin 40 mg (phase I)1

Inhibition of thrombin generation

Lasted for 24 h after a single dose of rivaroxaban 30 mg (phase I)2

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

VT

E r

ate

(%)

10

20

30

0

Total daily dose (mg) of rivaroxaban*Tested as 30 mg od

0 10 20 30* 40 50 60 Enoxaparin 40 mg od

10

20

30

0

Maj

or b

leed

ing

rate

(%

)

0 8 16 24 32 40 480

1

2

3

4

Ant

i-Fac

tor

Xa

activ

ity (

chan

ge fr

om b

asel

ine) Rivaroxaban 10 mg

Enoxaparin 40 mg

Time (hours)

The Extensive, Completed Phase III Studies of Rivaroxaban

Patients with medical illness

Patients with DVT

Patients at risk ofsecondary VTE

Patientswith ACS

Patientswith AF

Patients with PE

Patients undergoing

major OS

Rivaroxaban: Worldwide Approvals Across the Breadth of Indications

VTEx

Pulmonary embolismDeep vein thrombosis

Approved in 80 countries

SPAF

Ischaemic stroke


VTEp OS

Elective hip or knee replacement surgery


ACS

Unstable angina and myocardial infarction


RegistriesN≈97,000

Phase IV/NISN≈47,000

Phase IIIbN≈2,400

Phase II/IIIN≈51,000

CompletedPhase I–IIIb

N≈86,000

Over 275,000 patients expected

Bayer is Committed to Improving Thrombosis Management

The Extensive, Ongoing Exploration of Rivaroxaban

Patients atrisk of

secondary VTE

Paediatric patients

with VTEPatientswith ACS

Patients with medical illness

Patientswith DVT

Patientswith ESUS

Patientswith PAD

Patients withHF and CAD

Patientswith AF

Patientswith PE

Patients undergoing

major OS

Patients with chronic CADor PAD

COMPASSCAD/PAD Study

*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

30-day run-in,ASA 100 mg

Rivaroxaban 2.5 mg bid + ASA 100 mg od ± pantoprazole 40 mg od

1:1:1

N~21,000

Population:Documented CAD or PAD

Rivaroxaban 5.0 mg bid± pantoprazole 40 mg od

ASA 100 mg od± pantoprazole 40 mg od

Final follow-up

visit#

30-daywashout period*

Final washout

period visit

Start: Q2-13LPLV: Q1-18

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)

Indication: CAD/PADShort design: Randomized, double-blind, controlled trial

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

R

COMMANDER HFChronic HF/CAD Study

15–45-day follow-up

Rivaroxaban 2.5 mg bid (single or dual antiplatelet therapy)

Placebo (single or dual antiplatelet therapy)

~6–30 months

N=5,000

Population: HF and CAD after recent hospitalization

Global treatment end date*

End of study visit

*Date when 984 primary efficacy outcome events have occurred

www.clinicaltrials.gov/ct2/show/NCT01877915

FPFV: Q3-13LPLV: Q2-16Indication: HF/CAD5

Short design: Randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven, superiority 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

R

Objective: efficacy and safety of rivaroxaban for reducing the risk of MI, stroke or death in HF with CAD

EINSTEIN CHOICELong-Term Secondary VTE Prevention Study

*Completed 6–12 months (±1 month) with interruption of anticoagulation ≤1 week at randomization

1 month observation

period

Rivaroxaban 20 mg od

n~950


n~950

Day 1

ASA 100 mg od

n~950

12-month treatment duration

Population: DVT and/or PE after 6–12 months of anticoagulation*

N~2,850


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

R

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

FPFV: Q1-14LPLV: Q4-16Indication: VTEx

Short design: Multicentre, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority study

In Secondary Prevention of ACS

in Stroke Prevention

In PAD

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

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

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

Addressing the Unmet Medical Needs…..

LCMPhase IV + NIS Programme Overview

Study Indication ObjectiveFPFV/ LPLV

ACSspRivaroxaban plus dual antiplatelet therapy vs UFH during elective PCI (N=107)1

Q4-11Q1-13

SPAFEfficacy and safety of rivaroxaban for prevention of CV events in non-valvular AF patients undergoing cardioversion vs VKA (N=1,504)2

Q4-12Q1-14

SPAFEfficacy of rivaroxaban for LA thrombus resolution in non-valvular AF/flutter patients (N~60)3

Q3-13Q2-15*

SPAFSafety of uninterrupted rivaroxaban vs VKA in non-valvular AF patients undergoing catheter ablation (N~250)4

Q1-13Q4-14*

SPAF/ACSsp

Safety of two rivaroxaban regimens vs VKA after PCI in non-valvular AF patients (N~2,100)5

Q2-13Q2-15*

VTEp OSSafety and efficacy of rivaroxaban vs SOC in VTE prophylaxis after major orthopaedic surgery (N=17,701)6

Q1-09Q4-12

VTExSafety of rivaroxaban vs SOC for acute DVT treatment (N=4,800)7

Q2-12Q1-15*

SPAFSafety of rivaroxaban for stroke prevention in non-valvular AF. Region: Europe (N=6,000)8

Q2-12EU: Q4-14*

*Subject to change. Abbreviations and details of studies on www.clinicaltrials.gov are found in slide notes

X-PLORERPCI Study

*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


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

Population:Symptomatic CAD undergoing elective PCI‡

Index PCIRivaroxaban 20 mg*

Rivaroxaban 10 mg*

Rivaroxaban 10 mg* plus UFH 50 IU/kg bolus#

UFH 70–100 IU/kg bolus#

R 30 + 7 days

Follow-up

N=107

2:2:2:1

FPFV: Q4-11LPLV: Q1-13Indication: SPAFShort design: Prospective, randomized, semi-

blinded study

FOR PRESENTATION PURPOSES ONLY. DO NOT DISTRIBUTE.

1-5 days prior

start PCI

0.5 hrs 2 hrs 6-8 hrs 48 hrs0.0

0.4

0.8

1.2

1.6

2.0

10 mg 20 mg10 mg + UFH UFH

Anti

-Xa (

U/m

L)

1-5 days prior

start PCI

0.5 hrs 2 hrs 6-8 hrs 48 hrs0.0

0.1

0.2

0.3

0.4


F1+

2 (

nm

ol/L)

1-5 days prior

start PCI

0.5 hrs 2 hrs 6-8 hrs 48 hrs0

2

4

6

8

10


TA

T c

om

ple

x (

mcg/L

)1-5

days prior

start PCI

0.5 hrs 2 hrs 6-8 hrs 48 hrs0.0

4.0

8.0

12.0

16.0

20.0


PT (

seconds)

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.

A rebound phenomenon was noticed in the heparin (only) group, but not with rivaroxaban.

RIVAROXABAN AT THE DOSES TESTED, EFFECTIVELY SUPPRESSED THROMBIN GENERATION AND AMPLIFICATION UPON BALLOON DILATATION AND

STENTING.

The results of Xplorer contrast with these of the Randomized, Open-label, Dose-Ranging 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.

Rivaroxaban 10mg

(n:30 )

Rivaroxaban

20mg

(n:32)

Rivaroxaban

10 or 20mg

(n:62)

Rivaroxaban 10mg plus

heparin

(n:29)

Heparin

(n:16)

Bailout AC therapy and/or flow limiting thrombotic event*

0 (0) 0 (0) 0 (0) 0 (0) 1 (6.25)

MYOCARDIAL INFARCTION

Peri-procedural 0 (0) 3 (9.4) 3 (4.8) 4 (13.8) 5 (31.3)

Spontaneous, up to 30 days 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

BLEEDING TIMI_class

Significant (major or minor) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

Requiring medical attention 4 (13.3) 1 (3.1) 5(8.1) 5 (17.2) 4 (25.0)

BARC_class

2, 3 or 5 3 (10.0) 1 (3.1) 4 (6.5) 4 (13.8) 3 (18.8)

3 or 5 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

AC denotes anticoagulation therapy. TIMI denotes Thrombolysis In Myocardial Infarction, ARC denotes academic research consortium, ND denotes not done

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.

X-VERTCardioversion Study

http://www.clinicaltrials.gov/ct2/show/NCT01674647 Ezekowitz MD et al. Am Heart J 2014

*CrCl 30–49 ml/min: 15 mg od

Population:Non-valvular AF lasting >48 hours or unknown duration, scheduled for cardioversion (electrical or pharmacological)

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

Objective: efficacy and safety of rivaroxaban versus VKA for prevention of cardiovascular events in AF patients scheduled for cardioversion

FPFV: Q4-12LPLV: Q1-14Indication: SPAF

Short design: Prospective, randomized, open-label, blinded endpoint evaluation, parallel-group, active controlled, multi-center study

No: delayedcardioversion

Yes: directcardioversion

42 days

42 days≥21 days

(max. 56 days)

1–5 days

30-day follow-up

30-day follow-up

Rivaroxaban20 mg od*


VKA (INR 2–3)

SOC

SOC

SOC

SOC



Car

dio

vers

ion

2:1

N=1,500VKA (INR 2–3)

VKA (INR 2–3) VKA (INR 2–3)2:1

R

R

Sufficient anti-coagulation

or immediate

TEE

Car

dio

vers

ion

Time to cardioversion by cardioversion strategy

*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)

Median time to cardioversion Patients cardioverted as scheduled*

Pat

ien

ts (

%)

0

20

40

60

80

100

77.0

36.3

Column2

p<0.001

Day

s

0

20

40

60

80

100

Early Delayed

p=0.628

p<0.001

RivaroxabanVKA

1 patient with inadequate

anticoagulation

95 patients with inadequate

anticoagulation

22 days

30 days

Delayed group

X-TRALA/LAA Thrombus Resolution Study

*CrCl 15–49 ml/min: 15 mg od

www.clinicaltrials.gov/show/NCT01839357

Population: Non-valvular AF or atrial flutter with LA/LAA thrombus detected via TEE 6 weeks

Rivaroxaban 20 mg od*

End-of-treatment TEE

Standard of care

30 days

Treatment assignment

(baseline data)

N~60

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

FPFV: Q3-13LPLV: Q2-15Indication: SPAFShort design: Single arm, multicenter, prospective,

open-label, interventional study

End offollow-up

VENTURE-AFCatheter Ablation Study

30±5 daysfollow-up


VKA (INR 2–3) VKA (INR 2–3)


≥28 days

Day 1 ≥4 weeks ≥8 weeks

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

Objective: safety of rivaroxaban versus VKA in AF patients undergoing catheter ablation

FPFV: Q1-13LPLV: Q4-14Indication: SPAFShort design: Randomized, open-label, active-

controlled, multicenter study


Ca

the

ter

ab

lati

on

pro

ce

du

re:

Intr

av

en

ou

s h

ep

ari

n (

targ

et

AC

T =

30

0–

40

0 s

ec

on

ds

)

R

N~25,013

1:1

Population: Paroxysmal or persistent non-valvular AF, first ever catheter ablation

PIONEER AF-PCIPCI Study

Rivaroxaban 15 mg od*# + clopidogrel

End of treatment (12 months)

Rivaroxaban 2.5 mg bid#

+ DAPT‡

VKA (INR 2.0–3.0)§ + DAPT‡

Rivaroxaban 15 mg od* + low-dose ASA

VKA + low-dose ASA

*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


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

FPFV: Q2-13LPLV: Q2-15Indication: SPAF/ACSShort design: Open-label, randomized, multicenter

study

N=2,100

1:1:1

Population: Paroxysmal, persistent or permanent AF, undergoing PCI (with stent placement)

R

Intended DAPT duration of 1, 6 or 12 months



Phase IIIbN≈2,400



N≈86,000



Clinical Trials vs Real-Life Experience

Clinical study Real life

Strict inclusion and exclusion criteria Strict study protocol Objectively adjudicated event rates Strict guidance for problematic cases

Only indications and contra-indications regulated

Dose recommendations for groupsof patients only

Over- and under-representation of events Limited guidance for problematic cases

Capturing Real-Life Experience with Rivaroxaban/Novel OACs

Bayer/Janssensupport

I and II (US)

(Europe)

Dresden NOAC

(Dresden, Germany)

Glo

bal

VT

E r

egis

trie

s

Nat

ion

al/r

egio

nal

reg

istr

ies

Global AF registry

Non-interventional studies

Results of RECORD Studies Confirmed in Real-Life Practice

Symptomatic VTE¹ Symptomatic VTE²0.0

0.5

1.0

1.5

2.0

0.600000000000001

0.600000000000001

1.3

1.0

Inci

de

nce

(%

)

Rivaroxaban

Enoxaparin

SOC

1. Turpie et al, 2011; 2. Turpie et al, 2013

0.0

2.0

4.0

6.0

8.0

10.0

0.4

2.2

7.0

0.4

1.7

4.7

0.2

1.8

6.5

0.3

1.4

3.2

Inci

de

nce

(%

)

Different treatment durations in RECORD and XAMOS; all events treatment emergent. SOC, standard of care (82% LMWH)

GARFIELD...Uptake of Novel OACs

VKA, Vitamin K antagonists; FXa, Factor Xa inhibitors; DTI, Direct thrombin inhibitors; AP, Antiplatelets



Phase IIIbN≈2,400



N≈86,000



Global Clinical IIR Status: 100 IIRs with Rivaroxaban Ongoing*

All

SPAF

VTEx

VTEp

ACS/atherosclerosis

Device surgery

Others

0 20 40 60 80 100 120

100

58

15

5

1

1

20

*Status Oct 2014 based on IMPACT

Worldwide IIR network

Americas13

Asia38

Europe43

Multinational6

Responsible Use is Crucial

The basicsRight dose for the

Right patient for the

Right indication

Practical questionsConcomitant medications

Transition to and from ‘Xarelto’

Management of bleeding

To Meet the Needs for Improved Treatments Options

Predictable, once daily oral

administration

Potent antithrombotic

activity

No routine coagulation monitoring

Broad therapeutic window

Long-term anticoagulation

therapy from hospital to home

Our R&D Goals

Scientific Research Continues in BAYER

Research in Indications with High Unmet Medical Needs

Blood Lung Heart Kidney

Thrombosis Pulmonary hypertension Heart failure Chronic kidney disease

Development of arterial or venous thrombi preventing blood flow in vessels

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

Anaemia

Decreased erythropoiesis in chronic kidney disease

Cardiology research covers diseases in:

Phase I (14) Phase II (14) Phase III (16)

CancerRoniciclib (BAY 1000394)(CDK-Inhibitor)

Heart FailureBAY 86-8050(Vasopr. Rec. Antag.)

Diabetic Nephropathy Finerenone(MR-Antagonist)

Heart FailureBAY 1067197(Part. Aden. A1 Agonist)

Skin and Lung InfectionsTedizolid

Adjuvant CRC with resected liver metastases

Regorafenib

CancerAnetumab ravtansine (BAY 94-9343)(Mesothelin-ADC)

CancerBAY 1125976 Allosteric AKT 1/2 - I.

CHF Finerenone (BAY 94-8862)(MR-Antagonist)

Additional IndicationsSorafenib

HemophiliaDamoctocog alfa pegol (BAY 94-9027)(peg rFVIII mutein)

Combination study in CRPC

Radium-223-Dichloride

Sympt. Uterine FibroidsBAY 1002670 (S-PRAnt)

CancerBAY 1143572PTEFb Inhibitor

NHLCopanlisib (BAY 80-6946)(PI3k Inhibitor)

Cancer

RegorafenibGram-negative PneumoniaAmikacin inhale

Breast CancerSorafenib

CancerBAY 2010112PSMA BiTE Antibody.

CancerBAY1082439 (PI3k Inhibitor)

BronchiectasisBAY 85-8501Neutroph. Elastase Inhibit.

PH.IIP

Riociguat (sGC Stimulator)

MACE prevention

RivaroxabanAdjuvant RCCSorafenib

CancerBAY 1179470FGFR2 Ab

ContraceptionBAY1007626 (Progestin IUS)

Cancer

Refametinib

(BAY 86-9766)

Diffuse Systemic sclerosis

Riociguat (sGC Stimulator)

CHF and CAD

Rivaroxaban

VV Atrophy Prasterone (Vaginorm)

Heart failureBAY 1142524Chymase Inhibitor

Lung diseaseBAY 1097761PEGylated Adrenomedullin

Worsening chronic heart failureVericiguat (BAY 1021189)(sGC Stimulator)

Raynaud's phenomenon Riociguat (sGC Stimulator)

Long-term VTE prevention

RivaroxabanContraceptionLCS 16

EndometrioseBAY 98-7196Intravaginal ring

CancerBAY1163877Pan-FGFR Inhibitor

AnemiaMolidustat (BAY 85-3934(HIF-PH Inhibitor)

Cancer

Radium-223-Dichlorid

Medically ill

Rivaroxaban

Non-CF Bronchiectasis

Cipro DPI

HCC 2nd line

Regorafenib

RESPITE study (insuff. responders to PDE5-inhib.)

Riociguat

Development Pipeline

New molecular entities (NME)

Life cycle management (LCM)

Status April 2014Selection of major Pharma pipeline projectsin clinical Phase I to III

*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

Cardiovascular

http://pharmatoday.bhc.cnb/APPS/BSP/DE/BSP-GPM/BSP-GPM.nsf/id/EN_Pipeline_external

Thank you very much for your attention

Rivaroxaban LCM studies program overview Martin van Eickels MD Head of Global Medical Affairs...

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