1 1 Innovation Wild

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Information about 1 1 Innovation Wild

Published on October 8, 2009

Author: Silja

Source: slideshare.net

Prof. Dr. Hanno Wild Bayer Schering Pharma AG Head of Global Lead Generation & Optimization Basle, October 08, 2009 Successful innovation within a post-merger environment

Challenges for the entire pharmaceutical industry Unprecedented change around the globe Regulatory and safety concerns Generics often first line therapy Pricing pressures Payers eclipsing doctors as decision makers Shifting portfolios from primary care to specialist-driven therapies Current economic crisis is reinforcing the trends in the markets Environmental Pressures Outsourcing and labor reduction to reduce costs Entry into new markets – biosimilars, services Focus on pharmerging markets M&A to enhance the pipeline and reduce cost Redesigning the commercial model Industry Challenges Continuously rising investments Higher attrition rates = lower number on NMEs Increasing hurdles regarding efficacy & safety Low hanging fruits have been picked Innovation crisis? Challenges for R&D

Regulatory and safety concerns

Generics often first line therapy

Pricing pressures

Payers eclipsing doctors as decision makers

Shifting portfolios from primary care to specialist-driven therapies

Current economic crisis is reinforcing the trends in the markets

Outsourcing and labor reduction to reduce costs

Entry into new markets – biosimilars, services

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 on NMEs

Increasing hurdles regarding efficacy & safety

Low hanging fruits have been picked

Innovation crisis?

Challenges for R&D Key reactions of Bayer/Bayer Schering Pharma - strong need for continuous steering Portfolio adjustments  Bayer Pharma 2002-2005 Mergers & Acquisitions  Schering Integration 2006 - 2008 Efficiency  Internal program 2009 - 2012 Further increase R&D productivity and innovation, Optimize internal processes and resource allocation Complement internal activities by innovation sourcing

Portfolio adjustments  Bayer Pharma 2002-2005

Mergers & Acquisitions  Schering Integration 2006 - 2008

Efficiency  Internal program 2009 - 2012

Further increase R&D productivity and innovation,

Optimize internal processes and resource allocation

Complement internal activities by innovation sourcing

Bayer Schering Pharma* Key Data Specialty Medicine Diagnostic Imaging General Medicine Women’s Healthcare * USA/Canada: Bayer HealthCare Pharmaceuticals Among the top 10 specialty pharma companies worldwide Focus on 4 major business units Sales 2008: EUR10,704 million Investments in R&D: mid term 15 – 17 % of total net sales

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

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

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

Focus indications

Research centered in Germany: Berlin & Wuppertal

Core competencies (e.g. Screening, MedChem, Pharmacology, Toxicology)

Specialty indications

Common mechanism research

Innovation centers US & China

Strategy for innovation sourcing

Expansion from specialty to larger indications

R&D for pharmerging markets

Bayer Schering Pharma’s R&D Pipeline A balanced mix of NME and LCM opportunities Status as of July 2009 Phase II (17) Phase III (18) 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 ® 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 BAY94-9172 (AV1 / ZK) Cancer DAST Inh. (BAY73-4506) 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 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 Phase I (8) 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 Despite the challenges to R&D, Bayer Schering Pharma brought a constant flow of NMEs to the market while reducing its cost basis New Molecular Entities (NME) Life Cycle Management (LCM)

At the end, however, this is not a numbers game… … more focus: Stringent quality criteria Consistency of strategies Flexible responses to new findings Transparent decision making and communication Talented people … it is about

Stringent quality criteria

Consistency of strategies

Flexible responses to new findings

Transparent decision making and communication

Talented people

 

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 Schering Pharma Top 10 Products Product [EUR million] 2007 2008 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

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