F&E bei Bayer Schering Pharma: Fokus auf echte Produktivität

Transcription

1 Frankfurt, November 03, 2009 Global Drug Discovery Bayer Schering Pharma AG Head of Global Lead Generation & Optimization Prof. Dr. Hanno Wild F&E bei Bayer Schering Pharma: Fokus auf echte Produktivität

2 Challenges for the entire pharmaceutical industry Unprecedented change around the globe Environmental Pressures Industry Challenges Challenges for R&D Regulatory and safety concerns Pricing pressures Payers eclipsing doctors as decision makers Current economic crisis is reinforcing the trends in the markets Outsourcing and labor reduction to reduce costs Focus on pharmerging markets M&A to enhance the pipeline and reduce cost Redesigning the commercial model Continuously rising investments Higher attrition rates = lower number of NMEs Increasing hurdles regarding efficacy & safety How to gain productivity? Page 2

3 Productivity What is the common understanding of productivity in Pharma R&D? Productivity based on number of Data points Synthesized compounds Active projects in different phases Phase transitions Projects in the pipeline Products launched p. a.. Number of active projects in different phases Number of synthesized compounds Number of Phase transitions Number of pipeline projects Number of launched products p. a. Often not considered sufficiently Quality of each component Value adding effect for the overall process Value of the process overall Number of data points Single components of the process are important and have to be optimized But: Only value generation in the context of the overall value chain describes true productivity Page 3

4 Page 4 Status, Strategy & Productivity

5 * USA/Canada: Bayer HealthCare Pharmaceuticals Investments in R&D: mid term % of total net sales Sales 2008: EUR10,704 million Focus on 4 major business units Among the top 10 specialty pharma companies worldwide Key Data Bayer Schering Pharma* Specialty Medicine General Medicine Women s Healthcare Diagnostic Imaging

6 Bayer Schering Pharma Top 10 Products Product [EUR million] YAZ / Yasmin / Yasminelle (Women s Healthcare) 1,042 1,222 Betaferon / Betaseron (Specialty Medicine) 1,028 1,144 Kogenate (Specialty Medicine) Adalat (General Medicine) Avalox /Avelox (General Medicine) Nexavar (Specialty Medicine) Mirena (Women s Healthcare) Levitra (General Medicine) Cipro / Ciprobay (General Medicine) Glucobay (General Medicine)

7 Mission of Global Drug Discovery at Bayer Schering Pharma Best in Class true Productivity (Value Generation) Identify & focus on high unmet medical need to generate future business that improves the quality of life for patients Discover highly differentiated & reimbursable Proof of Concept-candidates (SMOLs & Biologicals) suited for a rapidly changing pharma environment Explore new fields for Medicinal Care Being considered as the top pharmaceutics inventor by Patients, Physicians & Payors Page 7

8 Bayer Schering Pharma s R&D strategy Key factors to increase Productivity 1 more focus: 2 higher efficiency: 4 therapeutic research areas with activities from target discovery up to launch (reduced from 9) Increase in development candidate output at decreased cost per NME (global use of platforms, stringent resource allocation, site consolidation) 3 better quality: 4 value maximization: Proof-of-Concept approach and strict project progression criteria Common mechanism approach to utilize opportunities NME: New Molecular Entity Page 8

9 Bayer Schering Pharma s R&D Strategy Focus on Four Therapeutic Research Areas June 1999 Oncology June 2005 Oncology Cardiology Schering Bayer Cardiology Hematology Diabetes/Obesity Hematology Oncology Gynecology June 2007 Bayer Schering Pharma Cardiology Oncology Women s Healthcare Bayer COPD/Asthma Antiinfectives Oncology Gynecology, FC MM Andrology Dermatology Immunology/Inflam. Andrology Dermatology Immunology Diagnostic Imaging Diagnostic Imaging Schering Cardiology Gene Therapy Diagnostic Imaging Page 9

10 Page 10 Fully integrated discovery organisation allows maximum leverage of assets - Special common mechanism functions (CMR) - Value maximization cross and beyond own therapeutic areas Common mechanism approach - >2.8 million compound library and strong MedChem - Strengthened biologicals research function - World class pharmacology in cardiology, gynecology and molecular imaging - Integration of development functions in research process - Big box approach in Europe (cost efficiency, communication) - Very stringent criteria for phase transitions, e.g. for development candidates Well defined research process up to Proof-of-concept in man Fully integrated organisation instead of silos Efficiency, quality and value maximization Bayer Schering Pharma s R&D Strategy

11 Bayer Schering Pharma s R&D Strategy Focus combined with selected opportunities Focus Focus indications Research centered in Germany: Berlin & Wuppertal Core competencies (e.g. Screening, MedChem, Pharmacology, Toxicology) Specialty indications Opportunities Common mechanism research Innovation centers US & China Strategy for innovation sourcing Expansion from specialty to larger indications R&D for pharmerging markets Main Sites Employees in R&D 5,912 (as of Dec. 31, 2007) Global Drug Discovery Innovation Centers Berlin Wuppertal US West Coast Beijing Page 11

12 Bayer Schering Pharma s Value Chain Facts of R&D Productivity in Pharma Alignment of R&D and business on research area (General Project Frame) Portfolio funnel must deliver sustainable mid/late stage & reimbursable assets Rapid decision making based on appropriate expertise Project costs explode after PoC (proof of concept) First human data or PoC represent most significant first step in value generation required expertise for appropriate decision making Innovation Validation Commercial Valuation Page 12

13 Bayer Schering Pharma s R&D Strategy Leadership, Culture & People Entrepreneurship lived as No 1 behaviour Think strategically & prospectively on all management levels Drug hunting mindset Culture supports continous change Project/Expert teams as centers for innovation & decision making Page 13

14 Bayer Schering Pharma s R&D Pipeline A balanced mix of New Molecular Entities and LCM opportunities Phase I (8) Phase II (17) Phase III (18) PH in COPD Elastase Inhibitor Cancer L19-SIP Colorectal Cancer L19-TNFalpha Gastro IBD Lipoxin Cancer MN Immunoconjugate Cancer PI3K Inhibitor Cancer MEK- Inhibitor Hemophilia rec. Factor VII Acute Heart Failure Cinaciguat (sgc Activator) DME VEGF Trap-Eye PH in COPD / ILD Riociguat (sgc Stimulator) 2nd line Breast Cancer Lonaprisan (ZK-PRA) Lung / Ovar / Prostate Sagopilone (ZK-EPO) Alzheimer PET Imaging BAY (AV1 / ZK) Cancer DAST Inh. (BAY ) Liposomal Formulation Kogenate Breast Cancer Nexavar Ovarian or Peritoneal Cancer Nexavar Colorectal Cancer Nexavar Additional Indications Nexavar Lung Infection Cipro inhale Oral Contraception E2+DRSP Oral Contraception OC+DHEA Oral Contraception Valette plus Gram-neg. Pneumonia Amikacin inhale Medical ill Xarelto SPAF Xarelto VTE Treatment Xarelto wet AMD VEGF Trap-Eye CRVO VEGF Trap-Eye PAH Riociguat (sgc Stimulator) CTEPH Riociguat (sgc Stimulator) ACS Xarelto NSCLC Nexavar Multiple Sclerosis Alemtuzumab Bone Met. Prev. Breast Cancer Bonefos Dysmenorrhea (J) YAZ Oral Contraception YAZ Flex Oral Contraception Yasmin plus / YAZ plus Menopause Management Angeliq low-low Contraception LCS (ULD LNG) ACS Aspirin i.v. Contraception FC Patch Low Status as of July 2009 New Molecular Entities (NME) Life Cycle Management (LCM) Despite the challenges to R&D, Bayer Schering Pharma brought a constant flow of NMEs to the market while reducing its cost basis Page 14

15 Bayer Schering Pharma s R&D Strategy R&D costs and productivity Constant output of preclinical candidates at decreasing cost level Sum of the R&D budgets of 10 major Pharma companies in Billion * 2,5 R&D budget BSP in Billion * R&D budget in mio * , , Year Based on data from "Evaluate Pharma" Year All data from Evaluate Pharma, inflation corrected (1.5% p.a.) Success rates for overall development (preclinical launch) substantially increased for our core indications and over industry benchmark Page 15

16 Bayer Schering Pharma s R&D Strategy Facts about Innovation Reality at Bayer Schering Pharma Innovative Compound - Xarelto (innovative structure first oral FXa inhibitor on the market) Innovative Compound and Mode of Action - Nexavar (oral dual acting kinase inhibitor first targeted therapy in kidney cancer, only approved drug with overall survival benefit in liver cancer - Cinaciguat (sol. Guanylate Cyclase activator acute heart failure, Ph II) - Riociguat (sol. Guanylate Cyclase stimulator pulmonary hypertension, Ph III) Innovative Indication - Oral multi kinase inhibitor pulmonary hypertension Innovative Application Route - Mirena (IUS 5 years long acting contraceptive), Wafer and Patches in Women s Healthcare Innovation is a key productivity factor Page 16

17 Summary Productivity and costs are key challenges in PH R&D Strategies to increase true productivity Winning concepts: Proof of concept and Common Mechanism Operational Excellence and integrated technology platforms Focus on specialty and innovation in areas of high unmet medical need Global Networks: Capturing innovation potential worldwide Present pipeline assets have potential for sustainable BSP growth Our aspiration Become a recognized innovation driver in Cardiology, Oncology, Women s Health and Diagnostic Imaging Discover innovative drugs to improve the quality of life for patients Page 17

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19 Page 19 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 The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.