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Bayer Schering Pharma´s Approach to R&D:
Internal and external sourcing of innovation
Prof. Dr. Hanno Wild
Senior Vice President
Global Lead Generation & Optimization
Global Drug Discovery – Bayer Schering Pharma
Bayer – The inventor company
A journey through the world of research at Bayer
Reiner Fischer:
Research on tetramic acids (Evidor®) Elisabeth Perzborn, Susanne Röhrig,
Otto Bayer: Alexander Straub:
Research in isocyanate chemistry Research on factor Xa inhibitor Xarelto®
(Polyurethanes)
„Science is made by man“
Werner Heisenberg (1901-1976)
Felix Hoffmann:
Synthesis of Acetylsalicylic acid Hermann Schnell:
(Aspirin®)
Development of
Macrolon®
Gerhard Domagk: Klaus Grohe, Hans-Joachim Zeiler:
Research on sulfomamides (Prontosil®) Development of Ciprobay®
Page 2
Bayer Schering Pharma*
Key Data
Diagnostic
Imaging
Among the top 10 specialty
pharma companies worldwide General
Medicine
Focus on 4 major
business units
Sales 2008: Specialty
EUR10,704 million Medicine
Investments in R&D: Women’s
mid term 15 – 17 % of total Healthcare
net sales
* USA/Canada: Bayer HealthCare Pharmaceuticals
• Page 3
Bayer Schering Pharma
Top 10 Products
Product 2007 2008
[EUR million]
YAZ® / Yasmin® / Yasminelle® (Women’s Healthcare) 1,042 1,222
Betaferon® / Betaseron® (Specialty Medicine) 1,028 1,144
Kogenate® (Specialty Medicine) 818 848
Adalat® (General Medicine) 614 626
Avalox® / Avelox® (General Medicine) 445 462
Nexavar® (Specialty Medicine) 270 462
Mirena® (Women’s Healthcare) 361 462
Levitra® (General Medicine) 332 341
Cipro® / Ciprobay® (General Medicine) 383 338
Glucobay® (General Medicine) 298 304
Bayer Schering Pharma
Research Focus on Specialty Indications
Cardiology Oncology
Focus on acute heart Focus on large solid
failure, pulmonary tumors
hypertension, peripheral
arterial obstructive
disease
Women´s Health Diagnostic Imaging
Focus on gynecological Focus on molecular
therapies, incl. imaging in CNS,
endometriosis, uterine oncology and cardiology
fibroids
Main R&D Sites Innovation Centers
Innovation Forum • February 2009, Beijing • Page 5
Berlin Wuppertal US West Coast Beijing
• Page 5, Prof. Wild
Our R&D Pipeline
Late stage pipeline filled with innovative small molecules
Phase I (7) Phase II (17) Phase III (18)
Colorectal Cancer
Colorectal Cancer Acute Heart Failure
Acute Heart Failure Liposomal Formulation
Liposomal Formulation Medical ill
Medical ill NSCLC
NSCLC
L19-TNFalpha
L19-TNFalpha Cinaciguat
Cinaciguat Kogenate®
Kogenate® Xarelto®
Xarelto® Nexavar®
Nexavar®
(sGC Activator)
(sGC Activator)
Gastro IBD
Gastro IBD Breast Cancer
Breast Cancer SPAF
SPAF Thyroid Cancer
Thyroid Cancer
Lipoxin
Lipoxin DME
DME Nexavar®
Nexavar® Xarelto®
Xarelto® Nexavar®
Nexavar®
VEGF Trap-Eye
VEGF Trap-Eye
Cancer MN
Cancer MN Ovarian or Peritoneal
Ovarian or Peritoneal VTE Treatment
VTE Treatment Multiple Sclerosis
Multiple Sclerosis
Immunoconjugate
Immunoconjugate PH in COPD // ILD
PH in COPD ILD Cancer
Cancer Xarelto®
Xarelto® Alemtuzumab
Alemtuzumab
Riociguat
Riociguat Nexavar®
Nexavar®
Cancer
Cancer (sGC Stimulator) wet AMD
wet AMD Bone Met. Prev.
Bone Met. Prev.
PI3K Inhibitor (sGC Stimulator) CRC VEGF Trap-Eye Breast Cancer
PI3K Inhibitor CRC VEGF Trap-Eye Breast Cancer
2nd line Breast Cancer
2nd line Breast Cancer Nexavar®
Nexavar® Bonefos®
Bonefos®
Cancer
Cancer Lonaprisan (ZK-PRA) CRVO
CRVO
MEK-Inhibitor Lonaprisan (ZK-PRA) Additional Indications VEGF Trap-Eye OC
MEK-Inhibitor Additional Indications VEGF Trap-Eye OC
Lung // Ovar // Prostate
Lung Ovar Prostate Nexavar®
Nexavar® YAZ® Flex
YAZ® Flex
Hemophilia
Hemophilia Sagopilone (ZK-EPO) PAH
PAH
rec. Factor VII Sagopilone (ZK-EPO) Lung Infection Riociguat Menopause Management
rec. Factor VII Lung Infection Riociguat Menopause Management
Alzheimer PET Imaging
Alzheimer PET Imaging Cipro® inhale
Cipro® inhale (sGC Stimulator)
(sGC Stimulator) Angeliq low-low
Angeliq low-low
Diagnostic Imaging
Diagnostic Imaging Florbetaben
PET-Tracer Florbetaben OC CTEPH Contraception
PET-Tracer OC CTEPH Contraception
Cancer
Cancer E2+DRSP
E2+DRSP Riociguat
Riociguat LCS (ULD LNG)
LCS (ULD LNG)
Regorafenib
Regorafenib (sGC Stimulator)
(sGC Stimulator)
OC
OC Contraception
Contraception
Cancer
Cancer Valette plus
Valette plus ACS
ACS FC Patch Low
FC Patch Low
L19-SIP
L19-SIP Xarelto®
Xarelto®
Gram-neg. Pneumonia
Gram-neg. Pneumonia MRI LCM
MRI LCM
Amikacin inhale
Amikacin inhale HRPC
HRPC Gadovist®
Gadovist®
Alpharadin™
Alpharadin™
Status as of Oct 2009 New Molecular Life Cycle
Entities (NME) Management (LCM)
• Page 6
Our R&D Pipeline
Biologicals
Phase I (7) Phase II (17) Phase III (18)
Colorectal Cancer
Colorectal Cancer Acute Heart Failure
Acute Heart Failure Liposomal Formulation
Liposomal Formulation Medical ill
Medical ill NSCLC
NSCLC
L19-TNFalpha
L19-TNFalpha Cinaciguat
Cinaciguat Kogenate®
Kogenate® Xarelto®
Xarelto® Nexavar®
Nexavar®
(sGC Activator)
(sGC Activator)
Gastro IBD
Gastro IBD Breast Cancer
Breast Cancer SPAF
SPAF Thyroid Cancer
Thyroid Cancer
Lipoxin
Lipoxin DME
DME Nexavar®
Nexavar® Xarelto®
Xarelto® Nexavar®
Nexavar®
VEGF Trap-Eye
VEGF Trap-Eye
Cancer MN
Cancer MN Ovarian or Peritoneal
Ovarian or Peritoneal VTE Treatment
VTE Treatment Multiple Sclerosis
Multiple Sclerosis
Immunoconjugate
Immunoconjugate PH in COPD // ILD
PH in COPD ILD Cancer
Cancer Xarelto®
Xarelto® Alemtuzumab
Alemtuzumab
Riociguat
Riociguat Nexavar®
Nexavar®
Cancer
Cancer (sGC Stimulator) wet AMD
wet AMD Bone Met. Prev.
Bone Met. Prev.
PI3K Inhibitor (sGC Stimulator) CRC VEGF Trap-Eye Breast Cancer
PI3K Inhibitor CRC VEGF Trap-Eye Breast Cancer
2nd line Breast Cancer
2nd line Breast Cancer Nexavar®
Nexavar® Bonefos®
Bonefos®
Cancer
Cancer Lonaprisan (ZK-PRA) CRVO
CRVO
MEK-Inhibitor Lonaprisan (ZK-PRA) Additional Indications VEGF Trap-Eye OC
MEK-Inhibitor Additional Indications VEGF Trap-Eye OC
Lung // Ovar // Prostate
Lung Ovar Prostate Nexavar®
Nexavar® YAZ® Flex
YAZ® Flex
Hemophilia
Hemophilia Sagopilone (ZK-EPO) PAH
PAH
rec. Factor VII Sagopilone (ZK-EPO) Lung Infection Riociguat Menopause Management
rec. Factor VII Lung Infection Riociguat Menopause Management
Alzheimer PET Imaging
Alzheimer PET Imaging Cipro® inhale
Cipro® inhale (sGC Stimulator)
(sGC Stimulator) Angeliq low-low
Angeliq low-low
Diagnostic Imaging
Diagnostic Imaging Florbetaben
PET-Tracer Florbetaben OC CTEPH Contraception
PET-Tracer OC CTEPH Contraception
Cancer
Cancer E2+DRSP
E2+DRSP Riociguat
Riociguat LCS (ULD LNG)
LCS (ULD LNG)
Regorafenib
Regorafenib (sGC Stimulator)
(sGC Stimulator)
OC
OC Contraception
Contraception
Cancer
Cancer Valette plus
Valette plus ACS
ACS FC Patch Low
FC Patch Low
L19-SIP
L19-SIP Xarelto®
Xarelto®
Gram-neg. Pneumonia
Gram-neg. Pneumonia MRI LCM
MRI LCM
Amikacin inhale
Amikacin inhale HRPC
HRPC Gadovist®
Gadovist®
Alpharadin™
Alpharadin™
Status as of Oct 2009 New Molecular Life Cycle NBE
Management (LCM) New biological entity
Entities (NME)
• Page 7
Our R&D Pipeline Provides a Balanced Mix
of NME and LCM Opportunities
Phase I (7) Phase II (17) Phase III (18)
Colorectal Cancer
Colorectal Cancer Acute Heart Failure
Acute Heart Failure Liposomal Formulation
Liposomal Formulation Medical ill
Medical ill NSCLC
NSCLC
L19-TNFalpha
L19-TNFalpha Cinaciguat
Cinaciguat Kogenate®
Kogenate® Xarelto®
Xarelto® Nexavar®
Nexavar®
(sGC Activator)
(sGC Activator)
Gastro IBD
Gastro IBD Breast Cancer
Breast Cancer SPAF
SPAF Thyroid Cancer
Thyroid Cancer
Lipoxin
Lipoxin DME
DME Nexavar®
Nexavar® Xarelto®
Xarelto® Nexavar®
Nexavar®
VEGF Trap-Eye
VEGF Trap-Eye
Cancer MN
Cancer MN Ovarian or Peritoneal
Ovarian or Peritoneal VTE Treatment
VTE Treatment Multiple Sclerosis
Multiple Sclerosis
Immunoconjugate
Immunoconjugate PH in COPD // ILD
PH in COPD ILD Cancer
Cancer Xarelto®
Xarelto® Alemtuzumab
Alemtuzumab
Riociguat
Riociguat Nexavar®
Nexavar®
Cancer
Cancer (sGC Stimulator) wet AMD
wet AMD Bone Met. Prev.
Bone Met. Prev.
PI3K Inhibitor (sGC Stimulator) CRC VEGF Trap-Eye Breast Cancer
PI3K Inhibitor CRC VEGF Trap-Eye Breast Cancer
2nd line Breast Cancer
2nd line Breast Cancer Nexavar®
Nexavar® Bonefos®
Bonefos®
Cancer
Cancer Lonaprisan (ZK-PRA) CRVO
CRVO
MEK-Inhibitor Lonaprisan (ZK-PRA) Additional Indications VEGF Trap-Eye OC
MEK-Inhibitor Additional Indications VEGF Trap-Eye OC
Lung // Ovar // Prostate
Lung Ovar Prostate Nexavar®
Nexavar® YAZ® Flex
YAZ® Flex
Hemophilia
Hemophilia Sagopilone (ZK-EPO) PAH
PAH
rec. Factor VII Sagopilone (ZK-EPO) Lung Infection Riociguat Menopause Management
rec. Factor VII Lung Infection Riociguat Menopause Management
Alzheimer PET Imaging
Alzheimer PET Imaging Cipro® inhale
Cipro® inhale (sGC Stimulator)
(sGC Stimulator) Angeliq low-low
Angeliq low-low
Diagnostic Imaging
Diagnostic Imaging Florbetaben
PET-Tracer Florbetaben OC CTEPH Contraception
PET-Tracer OC CTEPH Contraception
Cancer
Cancer E2+DRSP
E2+DRSP Riociguat
Riociguat LCS (ULD LNG)
LCS (ULD LNG)
Regorafenib
Regorafenib (sGC Stimulator)
(sGC Stimulator)
OC
OC Contraception
Contraception
Cancer
Cancer Valette plus
Valette plus ACS
ACS FC Patch Low
FC Patch Low
L19-SIP
L19-SIP Xarelto®
Xarelto®
Gram-neg. Pneumonia
Gram-neg. Pneumonia MRI LCM
MRI LCM
Amikacin inhale
Amikacin inhale HRPC
HRPC Gadovist®
Gadovist®
Alpharadin™
Alpharadin™
Status as of Oct 2009 New Molecular Life Cycle
Entities (NME) Management (LCM)
Despite the challenges to R&D, Bayer Schering Pharma brought a
constant flow of NMEs to the market
• Page 8
Bayer Schering Pharma’s pipeline & products
First in class & targeting high unmet medical need
Nexavar, the first kinase inhibitor approved for renal & liver cancer
First targeted therapy in kidney cancer (RCC)
Only approved drug with overall survival benefit in liver cancer (HCC)
Approved in >90 countries for RCC, >80 countries for HCC
Xarelto, a paradigm shift in anti-thrombotic treatment
First oral, once-daily factor Xa inhibitor
Comprehensive development program in five thrombosis related
indications
Approved for VTE prevention after orthopedic surgery (EU, Canada &
other regions)
Riociguat - commitment to target unmet medical need
Potential to redefine treatment for pulmonary hypertension
Target subtypes of pulmonary hypertension without
currently approved standard medication
Bayer Schering Pharma’s innovations
Bayer Schering Pharma’s innovations
Bayer Schering Pharma
Extending Innovation Sources
Tap into external innovation
potential, worldwide
global R&D spent >1000fold higher
than BSP internal R&D
Building a
Strengthening network of
the research research
competencies satellites innovation sources: academia,
biotechs, & other companies
Establishing
Shaping the new
research leverage full potential of in-licensed
partnering
landscape innovation by utilizing our in-house
models
technology platforms
Innovation Sourcing
… by building up alliances and collaborations
Basic Drug Preclin. Submission/
Clinical Development
Research Discovery Develop. Approval
Early stage drug discovery Late stage drug discovery
alliances & collaborations alliances (licensing)
Biotech Academia Biotech Co-development
Access to external expertise
Access to external expertise Scarcity of late stage
Scarcity of late stage
Competitive advantage
Competitive advantage compounds available
compounds available
Enhanced discovery capability
Enhanced discovery capability
High degree of flexibility
High degree of flexibility High-cost of sourcing
High-cost of sourcing
No need to build up in-house programs
No need to build up in-house programs compounds
compounds
(lower risks and costs)
(lower risks and costs)
Current trend:
Current trend:
Increase in early drug discovery alliances
Increase in early drug discovery alliances
11
Global Networks
Showcase Oncology
Biomarker Research
Research Clinical
Pre-clinical Phase I / Development
Target Lead Lead Development POC
Discovery Discovery Optimization Phase II Phase III
Technology Collaborations & Acquisitions in 2008
14
12
Emerging market
INDIA
India is one of the biggest
emerging markets in Asia.
India’s excellent education
system has resulted in a large
number of highly skilled
scientists.
The pharmaceutical sector is
growing fast
India is a likely future
innovation powerhouse
Very attractive to gain an option to innovation
Very attractive to gain an option to innovation
from a new player
from a new player
13
Current and future interests for collaborations
In the past, Bayer Schering Pharma has mainly collaborated
with Indian companies in the field of chemical synthesis for
research and CMC purposes
We are interested to continue and expand these activities for
small molecules as well as in the field of biologicals
We are continously looking into opportunities for outsourcing of
different steps of the R&D process
In addition, we are interested to source innovation for our core
indications from targets to compounds in development
We want to expand our external network for
We want to expand our external network for
outsourcing and innovation sourcing
outsourcing and innovation sourcing
14
Bayer Schering Pharma has a Successful Partnering Record
Development/
Distribution
Discovery
Technologies
15
Summary
Bayer Schering Pharma
is commited to innovation China
China
Internal and external networks are key for
being world class in research & development
Singapore
Seeking potential partners for
- target validation research
India
- out-sourcing of different steps of the R&D process
- in-licensing of drug candidates
India
BSP will foster collaborations in Asia
to develop new therapeutic options and
create value for the patients
Korea
16
Forward-Looking Statements
This presentation may contain forward-looking statements based
on current assumptions and forecasts made by Bayer Group or
subgroup management.
Various known and unknown risks, uncertainties and other factors
could lead to material differences between the actual future
results, financial situation, development or performance of the
company and the estimates given here. These factors include
those discussed in Bayer’s public reports which are available on
the Bayer website at www.bayer.com.
The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or
developments.
Bayer Business Areas
Overview
108,600 Employees 2008 Sales: EUR 32.9 billion
~ 350 subsidiaries 2008 R&D Budget: EUR 2.8 billion
Business Segments:
Nutrition High-tech Materials Health Care
Crop Protection Materials Bayer Schering Pharma
EnvironmentalScience Systems Consumer Care
BioScience Diabetes Care
Animals Health
Page 18
Bayer Schering Pharma
Early Stage Licensing – Search Priorities
Oncology:
Two major principles: anti- proliferative and anti-angiogenic
Targeted therapeutics for solid tumors; small molecules that have shown good data in animal
models; functional antibodies and immunoconjugate approaches; new targets for oncology.
Cardiovascular:
Targets, small molecules and biologicals (incl. AB) for heart failure, atrial fibrillation,
cardioprotection, sepsis, acute respiratory distress syndrom as well as severe chronic
obstructive pulmonary disease.
Women’s Health:
Targets, small molecules and biologicals (incl. AB) for endometriosis, uterine fibroids
(Leiomyoma), bleeding disorders, fertility control and menopause management (hot flushes).
Diagnostic Imaging:
Positron Emission Tomography (PET) tracers (preferably F18) for Oncology, CNS and CV.
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