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Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
Clinical Development in Asia Pacific and Japan    	  Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer
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Clinical Development in Asia Pacific and Japan Rolf Schuermann, M.D., Ph.D., Vice-President, Head of Global Clinical Development Women’s Healthcare, Bayer

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

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

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  • 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

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