3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

1. Bayer Schering Pharma
Clinical Development in Asia Pacific and Japan
Dr. Rolf Schürmann
Vice-President,
Head of Global Clinical Development Women’s Healthcare
Bayer Schering Pharma AG
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010

2. Agenda
Global R&D Environment
Benefits of R&D in Asia Pacific and Japan
Examples
Outlook
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 2

3. Agenda
Global R&D Environment
Benefits of R&D in Asia Pacific and Japan
Examples
Outlook
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 3

4. Current Global R&D Environment
 Global competition
 Rising costs of development
 Decreasing productivity of R&D
 An industry under pressure
 Post Cox-2 environment
 Public disclosure
 Limited pool of trained investigators for clinical trials
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 4

5. “Within three years, up to 65% of
FDA-regulated clinical trials for the top
pharmaceutical companies
will be conducted outside of U.S…”
Tufts Outlook 2008 Report, January 2008
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 5

6. Agenda
Global R&D Environment
Benefits of R&D in Asia Pacific and Japan
Examples
Outlook
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 6

7. Off-shoring Clinical Development
 Sponsor perspective:
 Access to large number of patients, access to treatment naive patients
 Potential of emerging markets
 Economic advantage
 Health authority perspective:
 Drive to promote domestic biotechnology and medical research
 International agreements easing FDA/EMEA acceptance
 But: Acceptability of foreign data?
 Investigator perspective:
 Personal scientific interest and development of staff
 Financial incentives
Source: FDA, Visiongain, McKinsey
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 7

8. How to optimize global patient recruitment
- Shifting Global Patient Recruitment -
 Phase III trials in November 2007
 30% of clinical trials conducted
outside of US (157 of 509)
 More than 50% of study sites
outside of US (13,521 of 24,206)
 From 1995 to 2005, the number of countries
serving as trial sites outside
the US more than doubled
Ethical and Scientific Implications of the Globalization of Clinical
Research S Glickman et al. NEJM 360;8
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 8

9. Lead time to start a study in Asian
countries
Country CTA review time Special requirements for
CTA 2 4 6 8 10 12 Months
China* 9 – 12 months Full Dossier (TRDs + clinical and
non clinical reports) required for
CTA.
Japan CTN 30 days CT Notification form + study
protocol, IC and CRF
Draft protocol can be accepted to
start CTA review.
Korea Ca. 2 months Technical documentation and
study protocol
Taiwan 2- 3 months Technical documentation and
study protocol
EU / US CTA / IND 30 days Technical documentation and
study protocol
Multinational studies
60 days
* Data from Hong Kong where review is approx 3 months long can be used only if CTA is approved by SFDA.
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 10

10. Japan – South Korea – China
Increasing communications among regulators
2007 April in Seoul
2008 April in Tokyo
http://www2.convention.co.jp/eaprs2008ph/en/purpose/
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 11

11. Agenda
Global R&D Environment
Benefits of R&D in Asia Pacific and Japan
Examples
Outlook
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 12

12. Nexavar is the First Drug to Demonstrate
Overall Survival Benefit in HCC
Hazard ratio Sorafenib Placebo
Median overall survival (44% improvement)* 0.69 46.3 weeks 34.4 weeks
Median time to progression (73% prolongation)† 0.58 24.0 weeks 12.3 weeks
Sorafenib vs placebo: *P=0.0006; †P=0.000007
Overall Survival Time to Progression
Nexavar bears the potential to become the new standard
of care in patients with unresectable liver cancer
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 13

13. Liver Cancer (HCC): Representing a Significant
Therapeutic Opportunity
Annual cases of HCC
 Unprecedented results for
Nexavar in HCC – improvement
of overall survival by 44%
 Approved for treatment of HCC
e.g. in Europe, USA, Canada,
Korea, India, China, Japan
 Additional studies in HCC
E.U. ongoing (combination, post-
U.S. 54,000 TACE, adjuvant setting)
15,000 China
346,000 Japan  No near-term major competitors
40,000 anticipated
Globally more than 620,000 new cases of HCC annually
Source: Globcan 2002
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 14

14. Nexavar: Overall Survival in Asia-
Pacific HCC Study
1.00 Sorafenib
Median: 6.5 months
(95% CI: 5.6-7.6)
Survival Probability
0.75
Placebo
Median: 4.2 months
(95% CI: 3.7-5.5)
0.50
0.25
HR (S/P): 0.68
95% CI: 0.50-0.93
P=0.014
0
0 2 4 6 8 10 12 14 16 18 20 22
Patients at Risk Months
Placebo 76 62 41 26 23 15 9 5 4
Adapted from Cheng A et al. Presented at ASCO Annual Meeting; May 30-June 3, 2008; Chicago, IL. 1 0 0
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 15

15. Nexavar: Comparison of Efficacy Between the
Asia-Pacific and SHARP Trials
Asia-Pacific2 SHARP1
Hazard Ratio Hazard Ratio
End point (95% CI) P-value (95% CI) P-value
0.68 0.69
OS 0.014 <0.001
(0.50-0.93) (0.55-0.87)
0.90 1.08
TTSP 0.498 0.768
(0.67-1.22) (0.88-1.31)
0.57 0.58
TTP <0.001 <0.001
(0.42-0.79) (0.45-0.74)
0.62 0.65
PFS <0.001 <0.001
(0.46-0.82) (0.52-0.79)
 Patients on drug from SHARP trail experienced a 44% OS benefit
 Patients on drug from AP trail experienced a 47% OS benefit
1. Llovet JM et al. NEJM, 2008.
2 Adapted from Cheng A et al. Presented at ASCO Annual Meeting; May 30-June 3, 2008; Chicago, IL.
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 16

16. Xarelto: #1 patient enrolment globally and the high
recruitment rate saved 2 months to end the trial
14
12
10
8
6
4
2
0
Recruitment duration % of Total patients
BSP International Hemato/cardio Clinical trail (2006/2007)
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 17

17. AP regional and Global Trials recruiting
China Korea
Dragon Dragon
11608 Fxa
11609 Fxa
11708 Fxa
Hong Kong
Dragon
HCC 11546
Australia
11213
11714
11223
New Zealand
11213
11714
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 18

18. China On-going AP Trials Ph I to III
Gadovist 91682
Primovist Patent-1
Patent-2 Chest 1
Chest 2 Einstein
Korea
Pakistan Einstein ext Magellan 91682
Magellan r-th. Gastric Patent-1
Maestral Storm Nexus Patent-2
ACE Maestral Chest 1
13085 Alemb. Chest 2
VEGF YAZ 1 Einstein
Q OC Qlaira Einstein ext
YAZ YAZ 2 Magellan
India LCS 12917 Gastric
91681 Taiwan Post Tace
Einstein Patent-1 Storm
Einstein ext Patent-2 NSCLC
Magellan Chest 1 Zeal
View-2 Chest 2 View-2
Hong Kong Einstein LCS
Einstein Einstein ext 12007
Einstein ext Magellan 12917
Magellan Storm
Thailand Storm Step
Einstein ACE 12917
Einstein ext Maestral
Magellan YAZ
Zeal 12007
Maestral
Malaysia Philippines
Q libido Einstein
Q tolerability Einstein
Einstein ext
Einstein ext
Maestral
Magellan
Australia
91681 91749 New Zealand
Singapore 91783 91784
Chest 1
Patent-1 Patent-1 Patent-2
Indonesia Chest 1 Chest 2
Chest 2
Einstein Einstein
Einstein Einstein Einstein ext
Einstein ext Einstein ext
Einstein ext Magellan Storm
Magellan Magellan
Magellan Step Maestral
Storm Storm
Maestral Potent Beyond F-up
NSCLC Step
Zeal CARE 1 CARE 2
12917
13085 View-2 FC
View-2 12917 Q libido
12917 Q tolerability
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 19

19. Japan: Most of the Phase III are Global Trials Involving
Japanese Centers
Domestic  Shorter development time for Bayer’s
programs development assets.
Pan-Asian  Earlier access to the Japanese market.
trials
 No drug lag in Japan.
(incl. JP)
 More development projects within the
same resource frame.
Global trials
 Increased probability of regulatory
(incl. Japan) success.
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 20

20. Japan Development Portfolio by BUs (Sep. 2009)
Preclinical or Pending Decision Phase I Phase II Phase III Under Review Approval in 2009
Amikacin inhale XARELTO CIPRO Inhale Cinaciguat XARELTO GLUCOBAY ADALAT CR
VAP VTE Treatment COPD Acute HF Stroke Px aFib ODT 40 mg Small
XARELTO Riociguat XARELTO CIPRO IV
BAY 60-4552 sGC
VTE Px OS PH-LVD VTE Px Medically ill (PAA)
ADAPTINOL XARELTO XARELTO
LCM VTE Px Abdo. surgeries ACS
FOSRENOL LCM ADALAT Riociguat
Sachet FDC Pulmonary HT
FOSRENOL LCM ADALAT Riociguat
Pre-dialysis HD Pulmonary CTEPH
BAY 94-9172 PET BAY 94-9172 PET GADOVIST
[18F]Glutamic acid PET [18F]SIGMA-2 PET
Alzheimer (P-II) Alzheimer (P-III) Brain Met
IOPAMIRON
[18F]FEDAA 1106 PET [18F]DPA-714 PET
Plastic PFC (AS)
GADOVIST
Whole Body
GADOVIST
CNS
NEXAVAR NEXAVAR NEXAVAR NEXAVAR NEXAVAR
CRC GC 1st line S1 Ovarian cancer Post-TACE HCC Unresectable HCC
NEXAVAR NEXAVAR DAST CAMPATH NEXAVAR FLUDARA oral
Thyroid cancer Breast cancer Cancer GVHD (ISS) NSCLC 3rd/4th line B-CLL
L19-SIP NEXAVAR NEXAVAR FLUDARA iv
Cancer GC 1st line Cape Adjuvant HCC NHL
L19-TNF alpha NEXAVAR NEXAVAR
Cancer GC 2nd line paclitaxel Thyroid
BAY VII VEGF Trap VEGF Trap BETAFERON
Hemophilia DME AMD (PAAs)
KOGENATE liposome VEGF Trap VEGF Trap
Hemophilia Myopic CNV AP/J CRVO
LIPOXIN KOGENATE-PF
Gastroenterology Hemophilia
KOGENATE-FS
2000 IU (PAAs)
S-PR Antagonist E2+DRSP YAZ
Fibroids Contraception Dysmenorrhea
ER Agonist DRSP Successor MIRENA
Vasomotor symptom Contraception (PAA)
SEGRA Topical
Atopic dermatitis
GME DGI ONC STH WHC Intendis
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 21

21. Agenda
Global R&D Environment
Benefits of R&D in Asia Pacific and Japan
Examples
Outlook
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 22

22. GD Asia Facility Opening
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 23

23. Summary and Outlook
 The trend for off-shoring of clinical research into the
Asia-Pacific region will continue
 The are limits in how far regional externalization of
R&D is possible (ethnicity, global acceptance)
 Bayer Schering Pharma will continue to significantly
invest global R&D resources into the AP region
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 24

24. Thank you for your kind attention
Your questions?
Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 25

25. Dr. Rolf Schürmann GTCBio , Seattle, Jan 2010 • Page 26