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Merck Serono the Largest Division of the Merck Group

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Merck Serono the Largest Division of the Merck Group Personalisierte Medizin in der Praxis Dr. Bernhard Kirschbaum DVFA Life Science Conference Frankfurt, 17. Juni 2009 Merck Serono The largest division of the Merck Group Merck Group Revenues FY2008: €7,558m Business sectors Pharmaceuticals Chemicals Revenues FY2008: €5,429m s n o Merck Serono i Liquid Crystals €4,987m s i v Consumer Health Care Performance & i €442m Life Science Chemicals D Cross-divisional functions / Central functions 2 Merck Serono – Key Facts & Figures Established: January 5, 2007 Business: Innovative small molecules & biopharmaceuticals Employees: >17,500 President: Elmar Schnee Headquarters: Geneva, Switzerland Key growth drivers: 3 Therapeutic Area Focus: From Research and Development to Market Research Development Market Oncology Oncology Autoimmune & Inflammatory New Specialist Therapies Diseases (AIID) Osteoarthritis*, Rheumatology*, etc. Neurodegenerative diseases Neurodegenerative diseases Multiple Sclerosis, Parkinson‘s* Fertility Fertility Endocrinology Endocrinology CM Care & local products * Currently in Development 4 Stratified Medicine: Definition Stratified Medicine is about adapting the treatment (molecule, dose, schedule,…) according to the patient’s characteristics for better efficacy and less adverse events. Personalized Medicine versus Stratified Medicine ¾ Individual patients, ¾ Patient sub-populations e.g. cancer vaccine made from the patient’s tumor 5 Stratified Medicine: Basic Principle 6 How Can Stratified Medicine Help the Patients, Clinicians and Healthcare Systems? Patients: Clinicians: • More effective & predictive • Therapy adjustment based on treatment options disease and patient characteristics • Tool to optimize dosing Healthcare Systems: • Better return on healthcare expenditure • More innovation through products with higher medical value using combination of Diagnostics (Dx) and Pharma (Rx) 7 Stratified Medicine as a Means to Contain Health Care Expenditures Source: www.whitehouse.gov • Senator Obama introduces Genomics and Personalized Medicine Act (2006) • President Obama’s economical stimulus bill allocates US$1.1bn for comparative effectiveness research (2009) Early identification of non responders has double value for the authorities – increasing pressure is expected: • Increased patient benefit • Heath care cost containment 8 Stratified Medicine and Pharma Business – New Opportunities / Added Complexity Improved benefit / risk ratio Smaller target market Faster, more directed development Opens doors to Business - Higher new indications + Outcome R&D costs Higher & faster market penetration Complication through Better price and Dx testing reimbursement In practice 9 Merck Serono Pipeline as per April 27, 2009 Phase PhaseI I Phase PhaseII II Phase PhaseIII III in Registration Aurora Kinase Inhibitor Atacicept Rebif New Formulation in CIS Rebif New Formulation AS703569 Multiple Sclerosis (REFLEX) Relapsing forms of MS Solid tumors and hematological FDA: Submission filed Erbitux® (cetuximab) Cladribine tablets malignancies Breast cancer Relapsing forms of MS Erbitux® (cetuximab) NHS-IL2-LT Cladribine tablets NSCLC Solid tumors Tucotuzumab celmoleukin in CIS 1st line therapy (EMD 273066/huKS-IL2), DI17E6 Safinamide EMEA: Submission filed Small cell lung cancer (SCLC) Solid tumors Early stage Parkinson’s Eg 5 inhibitor EMD 273063 (hu14.18-IL2), Safinamide Solid tumors and hematological immunocytokine Mid-to-late stage Parkinson’s malignancies Pediatric neuroblastoma Erbitux® (cetuximab) Oncology Adj Colon Cancer Survivac Cancer Vaccine EMD 273063 (hu14.18-IL2), Neurodegenerative Diseases Solid tumors immunocytokine Erbitux® (cetuximab) Melanoma Gastric Cancer Autoimmune & Inflammatory Diseases MEK Inhibitor Cilengitide Solid tumors Cilengitide Fertility SCCHN Glioblastoma IMO-2055, TLR9 Cilengitide Stimuvax® immunomodulator, Solid tumors Endocrinology NSCLC NSCLC TM Adecatumumab (MT201) Sonepcizumab (ASONEP ) Atacicept Colorectal Cancer Solid tumors Lupus Atacicept Fibroblast Growth Factor 18 Tesamorelin Rheumatoid Arthritis Osteoarthritis HIV patients with lipodystrophy Hyperglycosylated FSH (US only) Infertility (ART) ARX 201 Growth hormone deficiencies 10 Merck Serono Pipeline as per April 27, 2009 Phase PhaseI I Phase PhaseII II Phase PhaseIII III in Registration Aurora Kinase Inhibitor Atacicept Rebif New Formulation in CIS Rebif New Formulation AS703569 Multiple Sclerosis (REFLEX) Relapsing forms of MS Solid tumors and hematological FDA: Submission filed Erbitux® (cetuximab) Cladribine tablets malignancies Breast cancer Relapsing forms of MS Erbitux® (cetuximab) NHS-IL2-LT Cladribine tablets NSCLC Solid tumors Tucotuzumab celmoleukin in CIS 1st line therapy (EMD 273066/huKS-IL2), DI17E6 Safinamide EMEA: Submission filed Small cell lung cancer (SCLC) Solid tumors Early stage Parkinson’s Eg 5 inhibitor EMD 273063 (hu14.18-IL2), Safinamide Solid tumors and hematological immunocytokine Mid-to-late stage Parkinson’s Oncology malignancies Pediatric neuroblastoma Erbitux® (cetuximab) Adj Colon Cancer Survivac Cancer Vaccine EMD 273063 (hu14.18-IL2), Neurodegenerative Diseases Solid tumors immunocytokine Erbitux® (cetuximab) Melanoma Gastric Cancer Autoimmune & Inflammatory Diseases MEK Inhibitor Cilengitide Solid tumors Cilengitide Fertility SCCHN Glioblastoma IMO-2055, TLR9 Cilengitide Stimuvax® Endocrinology immunomodulator, Solid tumors NSCLC NSCLC TM Adecatumumab (MT201) Sonepcizumab (ASONEP ) Atacicept Colorectal Cancer Solid tumors v Lupus Atacicept Biomarker and or stratification Fibroblast Growth Factor 18 Tesamorelin Rheumatoid Arthritis Osteoarthritis HIV patients with lipodystrophy activities Hyperglycosylated FSH (US only) Infertility (ART) ARX 201 Growth hormone deficiencies Stratification is an important part of the Merck Serono strategy. Over 60% of our portfolio include Biomarker programs (predictive, mechanistic, surrogates). 11 Stratified Medicine: A Reality at Merck Serono • KRAS stratification for Erbitux® was key to therapeutic expansion. • Two stratified Phase III programs ongoing in Oncology – Cilengitide and Stimuvax • Implementation of stratified medicine approach across the whole development portfolio • Mandatory search for stratification biomarkers in our discovery process. • Creation of a specialized function dedicated to stratified medicine. 12 KRAS as a Predictive Marker for Erbitux® Efficacy in Metastatic Colorectal Cancer (mCRC) Chemotherapy (FOLFIRI) +/- Cetuximab in first line treatment of mCRC Cetuximab + FOLFIRI FOLFIRI 1.0 1.0 0.9 0.9 65% of patients 0.8 KRAS wild-type 0.8 0.7 0.7 65% of patients 0.6 0.6 KRAS wild-type 0.5 0.5 0.4 0.4 0.3 0.3 KRAS mutant 0.2 0.2 KRAS mutant 0.1 35% of patients 0.1 35% of patients Progression-free survival estimate estimate survival survival Progression-free Progression-free 0.0 0.0 0 2 4 68 1012 14 16 02468 1012 14 16 Months Months KRAS patient status influences the efficacy of Erbitux® 13 Improving tumor responses in mCRC: impact of tailored therapy and patient selection Personalized / tailored therapy – a new era in mCRC ITT, intent-to-treat population; wt, wild-type; LLD, liver-limited disease 1. Folprecht et al. ESMO 2008; 2. Van Cutsem et al. ESMO 2008; 3. Bokemeyer et al. ASCO 2008; 4. Van Cutsem et al. ASCO 2008; 5. Saltz et al. WCGIC 2007 14 Benefit-effort ratio Identified 60% pts (KRAS wt) treated with tailored therapy 100% pts treated with non-tailored therapy Target specific patient group (KRAS wt) No indicators to select patients y Maximize success in clinical studies y Variable success in clinical studies y Good clinical benefit in stratified patients y Variable clinical benefit in allcomers y Avoid unnecessary adverse effects y Risk of unnecessary adverse effects y Efficient from health economics perspective y Inefficient from health economics perspective 15 Extension of mCRC Indication to 1st Line with KRAS Stratification Treatment 3rd line 2nd line 1st line line 10,200 patients 32,200 patients 74,200 patients KRAS mutant KRAS mutant KRAS mutant KRAS mutant 35% 3,570 patients 11.270 patients 25,970 patients KRAS wild-type KRAS wild-type KRAS wild-type KRAS wild-type 65% 6,630 patients 20,930 patients 48,230 patients Treatment 16 weeks 20 weeks 32 weeks duration Treating 2nd and 3rd line, Treating 1st line, both KRAS wild-type and mutant: KRAS wild-type only: Market = 807,200 weeks treatment Market = 1,543,360 weeks treatment Bigger market enabled by stratification Higher penetration due to improved efficacy *Data for biggest 5 countries in Europe, Source: OncFoundation2007 projections for 2008 16 1 June 2009: Breakthrough for Erbitux in the UK ─ NICE recommendation thanks to KRAS 85 pieces of coverage for NICE (11 in major newspapers/newswires) 17 Cilengitide in Glioblastoma • Glioblastoma is a rare tumor, difficult to treat. • The methylation of the MGMT* gene promoter is a potential stratification marker. • Increased likelihood to succeed in Phase III using MGMT stratification. Stratified medicine helps to meet unmet medical needs and to access additional indications *O-Methylguanine-DNA Methyltransferase 18 Consequences of Stratified Medicine Implementation on Technology Management New capabilities → New complexities Drug Development Study Conduct Biomarker Technologies & BM Logistics Clinical Study Design 19 Implementation of Stratified Medicine Has a Strong Impact on Drug Development Process • Early integration in discovery and development process is important • Good early PK/PD research is essential • Competitive advantage to learn the lessons early • Address regulatory
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