Research and Development in Germany

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Research and Develoment in Germany Andreas Busch Head of Global Drug Discovery, Bayer Pharma Member of the ExCom of Bayer Healthcare FIP Kongress Pharmacy in Germany Setember 2015 Page 2 FIP Kongress

Five of these are from German comanies: 2 from Bayer, 2 from Boehringer Ingelheim, 1 from Fresenius 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Source: u to 2002:

1 Research and Develoment in Germany Andreas Busch Head of Global Drug Discovery, Bayer Pharma Member of the ExCom of Bayer Healthcare FIP Kongress Pharmacy in Germany Setember 2015 Page 2 FIP Kongress Pharmacy in Germany Setember was a record year for market launches in Germany Market launches of harmaceuticals with new active ingredients in Germany number (without biosimilars) Five of these are from German comanies: 2 from Bayer, 2 from Boehringer Ingelheim, 1 from Fresenius Source: u to 2002: Pharmazeutische Zeitung, since 2003: vfa Page 3 FIP Kongress Pharmacy in Germany Setember 2015 Page 4 FIP Kongress Pharmacy in Germany Setember 2015 The research location Germany has unique strengths, however We are committed to our major research sites in Germany Excellent research landscae: universities, research organizations, and industry Dense network of hositals: basis for rofessional clinical studies Strong rocess engineering and manufacturing know-how: roduction of small molecules and biologics Investment by: German harma: > 5 bn #1 in EU, #2 worldwide (after US) US harma > 50 bn Global R&D sending on healthcare > 120 bn Berkeley / Turku Oslo San Francisco Hematology Chemical and Oncology: Wuertal / Biologics Pharmaceuti- Thorium Berlin Cologne / Research & cal Develo- Conjugates Monheim Develoment ment: Polymer- Platform based Drug Delivery Oncology Cardiovascular Diseases Systems Gynecological Ohthalmology Theraies Biologics Research & Cross Indication Platform Develoment Cross Indication Platform Animal Health Research around 80% of our ~1350 MD/PhD scientists work in Germany Page 5 FIP Kongress Pharmacy in Germany Setember 2015 Page 6 FIP Kongress Pharmacy in Germany Setember

2 Tax-based research romotion in Germany would be an incentive for innovation have tax-based romotion for R&D OECD countries EU countries no tax-based romotion for R&D, includes Germany Introducing such romotion in Germany would: 1 Create Sustainable Growth 2 Generate Broadbased Growth Stimuli 3 Boost Germany as a Business Location One euro of romotion leads to one euro of additional sending. 1 Bayer has committed itself to reinvesting every euro received in tax-based research romotion into research. 1 Gutachten Prof. Wiegard (Regensburg) und Prof. Sengel (Mannheim) im Auftrag von BDI und VCI, 2011 Page 7 FIP Kongress Pharmacy in Germany Setember 2015 Page 8 FIP Kongress Pharmacy in Germany Setember 2015 Innovation sceticism is deely rooted in Germany Oenness to innovation through science is required on many levels How many Germans agree with the statement Science and technology make our lives healthier, simler, and more convenient? Successful Innovations Develoment of a society and the roserity of eole Only 60%! Social accetance and acknowlegment This is much less then other EU countries, not to mention countries like the US, China, or Jaan Ideas reliable business and regulatory frameworks technical and business know-how Market introductions of new technologies and roducts should not be hindered by regulatory agencies just because of olitical oinion or abstract concerns Source: OECD Survey 2013 Page 9 FIP Kongress Pharmacy in Germany Setember 2015 Page 10 FIP Kongress Pharmacy in Germany Setember 2015 Collaborations are art of Bayer s DNA We engage in collaborations worldwide including academia, start-us, and industry Collaborations between industry and academia consistenly create value for both sides Collaboration strength in Germany, e.g. DKFZ or our CoLaborator in Berlin Joint Labs German Cancer Research Consortia Crowdsourcing Licensing Center (DKFZ) IMI Grants4Targets, LDC Dortmund Grants4Leads Incubator CoLaborator SF, Berlin Close interaction, Multile rojects, shared labs close interaction Individual roject Transition of assets Arm s length Strategic Innovation Partnershi Broad Institute Joint Research Singaore Network Outsourcing Wuxi Atech Build to Buy Model Incetion4 Ohtalmology Investment High Tech Gründerfonds Page 11 FIP Kongress Pharmacy in Germany Setember 2015 Page 12 FIP Kongress Pharmacy in Germany Setember

07/10/2015 Pain treatment with COX--2 inhibitors only COX works in three of four atients Page 13 FIP Kongress Pharmacy in Germany Setember 2015 Page 14 FIP Kongress Pharmacy in Germany Setember 2015

3 07/10/2015 Pain treatment with COX--2 inhibitors only COX works in three of four atients Page 13 FIP Kongress Pharmacy in Germany Setember 2015 Page 14 FIP Kongress Pharmacy in Germany Setember 2015 Drugs against migraine work in less than half of the atient oulation Cancer drugs work in only every fifth atient Page 15 FIP Kongress Pharmacy in Germany Setember 2015 Page 16 FIP Kongress Pharmacy in Germany Setember 2015 Biomarker are the key to ersonalized medicine aroaches Personalized medicine is the combination of an efficaceous drug with biomarker diagnostics Classical Aroach Stratification of atients for successful clinical studies more aroved drugs Page 17 FIP Kongress Pharmacy in Germany Setember 2015 Personalized Medicine Clear data rotection laws (informed consent) are necessary for research, develoment, and theray using artientderived material or data Page 18 FIP Kongress Pharmacy in Germany Setember

Data rotection laws strongly influence the develoment of drugs Personal data and human samles are required for research and develoment However, same data rotection laws are alicable to any kind

rotection laws data rotection standards vary from country to country and within Germany even from state to state most data rotection laws are outdated and do not address new harmaceutical trends

.) to anonymize individual atient data Data Protection Laws comrise several legal uncertainties Page 19 FIP Kongress Pharmacy in Germany Setember 2015 Page 20 FIP Kongress Pharmacy in Germany

Investments in technologies and roduction facilities san decades, though, and often cost many millions if not billions.

This requires a broad and general accetance of safe new technologies within societies. Thank you!

Page 21 FIP Kongress Pharmacy in Germany Setember 2015 Major investment and risk is involved in bringing drugs to atients 10 Stages, 12 Years, More than 1 Billion er aroved drug Drug Research

regulatory Ongoing > 2 years Significant and increasing R&D Tolerability and authorities investment harmacodynamics at Bayer HealthCare U to 2 years or more Lab bn and animal Phase II: 100-500

4 Data rotection laws strongly influence the develoment of drugs Personal data and human samles are required for research and develoment However, same data rotection laws are alicable to any kind of industry telecommunication industry using data for advertisement healthcare industry using data for research Informed consent by atients required for such activities Governed by data rotection laws data rotection standards vary from country to country and within Germany even from state to state most data rotection laws are outdated and do not address new harmaceutical trends and advanced technologies which generate more and more data (e.g. bio-banking) with established otions (elsewhere..) to anonymize individual atient data Data Protection Laws comrise several legal uncertainties Page 19 FIP Kongress Pharmacy in Germany Setember 2015 Page 20 FIP Kongress Pharmacy in Germany Setember 2015 Bayer makes the largest investments in R&D of the harmaceutical industry in Germany. Investments in technologies and roduction facilities san decades, though, and often cost many millions if not billions. In Germany, Bayer advocates the introduction of a tax credit for R&D investments. The welfare of societies is closely linked to the ability to develo and use new technologies. This requires a broad and general accetance of safe new technologies within societies. Thank you! Consistent standards for atient informed consent would adress legal uncertainties and facilitate R&D at the individual harmaceutical comanies but also in cross-border rojects. Page 21 FIP Kongress Pharmacy in Germany Setember 2015 Major investment and risk is involved in bringing drugs to atients 10 Stages, 12 Years, More than 1 Billion er aroved drug Drug Research Preclinical Clinical Trials Regulatory Aroval Phase IV Studies and Registries BACKUP Discovery and biochemical testing 10,000 Test Comounds Phase I: healthy volunteers Data review by regulatory Ongoing > 2 years Significant and increasing R&D Tolerability and authorities investment harmacodynamics at Bayer HealthCare U to 2 years or more Lab bn and animal Phase II: atients exeriments 2,5 Safety and ddosing 2,3 Phase III: 1,000-10,000* atients Efficacy and safety 2,0 2,1 1,9 2,0 2,0 <10% of drugs Half of total R&D cost 1,7 1,8 make it all the < 250 < 5 way to aroval Test 1,5Comounds Test Comounds by health authorities 1, Years *Number of atients involved in Phase III trials can vary from less than 1,000 for rare diseases and u to 20,000 for more common diseases such as cardiovascular diseases Page 23 FIP Kongress Pharmacy in Germany Setember 2015 Page 24 FIP Kongress Pharmacy in Germany Setember

Bayer HealthCare delivers innovative medicines to atients for over a century Xarelto An innovation from Wuertal Established New Innovation Traditional inhibitors of the blood coagulation cascade:

story: 1999: identification of leads through High Throughut Screening 2000-2006: reclinical and clinical studies 2008: first aroval in Euroe Today, Xarelto is the modern oral anticoagulation drug

comarison to atients that are not treated with anticoagulants Page 25 FIP Kongress Pharmacy in Germany Setember 2015 Page 26 FIP Kongress Pharmacy in Germany Setember 2015 Our R&D strategy focuses on

fibrillation Pulm. (Arterial) Hyertension Inflammatory & Fibrotic Lung

5 Bayer HealthCare delivers innovative medicines to atients for over a century Xarelto An innovation from Wuertal Established New Innovation Traditional inhibitors of the blood coagulation cascade: very efficacious intraveneous alication or tablets with lower efficacy Rivaroxaban: Chemical marriage of two molecules to combine both high efficacy with oral bioavailability R&D continues Success story: 1999: identification of leads through High Throughut Screening : reclinical and clinical studies 2008: first aroval in Euroe Today, Xarelto is the modern oral anticoagulation drug that has the most aroved indications was investigated worldwide the most is being rescribed the most With Xarelto, two of three strokes in atients with atrial fibrillation can be revented in comarison to atients that are not treated with anticoagulants Page 25 FIP Kongress Pharmacy in Germany Setember 2015 Page 26 FIP Kongress Pharmacy in Germany Setember 2015 Our R&D strategy focuses on innovation in theraeutic areas with high medical need Hemohilia Anemia and other blood diseases Hematooiesis Hemoglobinoathies Ohthalmology Hematology Oncology Cardiology Heart Failure, Atrial fibrillation Pulm. (Arterial) Hyertension Inflammatory & Fibrotic Lung Conditions Vascular Dysfunction (e.g. rht) Thrombosis, ACS Acute CV organ disorders Chronic kidney disease Gynecology Wet AMD & DME Dry AMD & Stargardt disease Cell Cycle / Survival Signaling Immunotheray / Antibody- Drug Conjugates Tumor Metabolism / Hyoxia Chromatin Modulation / OncoGenomics Myeloroliferative neolasms Endometriosis Uterine Fibroids PCOS Page 27 FIP Kongress Pharmacy in Germany Setember

Company Profile. German-Taiwan Biotech Seminar 6 November 2017

Company Profile. German-Taiwan Biotech Seminar 6 November 2017 Company Profile German-Taiwan Biotech Seminar 6 November 2017 Our Mission Bayer: Science For A Better Life A growing and aging world population requires an adequate supply of food and improved medical