Ce diaporama a bien été signalé.
Nous utilisons votre profil LinkedIn et vos données d’activité pour vous proposer des publicités personnalisées et pertinentes. Vous pouvez changer vos préférences de publicités à tout moment.

2016/03 – Cowen HC Conference

1 494 vues

Publié le

2016/03 – Cowen HC Conference

Publié dans : Santé
  • The 3 Secrets To Your Bulimia Recovery ■■■ http://tinyurl.com/yxcx7mgo
       Répondre 
    Voulez-vous vraiment ?  Oui  Non
    Votre message apparaîtra ici
  • The 3 Secrets To Your Bulimia Recovery ➤➤ http://ishbv.com/bulimiarec/pdf
       Répondre 
    Voulez-vous vraiment ?  Oui  Non
    Votre message apparaîtra ici
  • Soyez le premier à aimer ceci

2016/03 – Cowen HC Conference

  1. 1. Cowen & Co. Health Care Conference Dr. Elias Zerhouni, President – Global R&D Boston – March 8, 2016
  2. 2. 2 Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  3. 3. Four Strategic Priorities 3 Reshape the portfolio Deliver outstanding launches Simplify the organization Sustain innovation in R&D 1 2 3 4 Taking our Strategy Forward in 2016
  4. 4. Significant R&D Turnaround since 2012 (1) From first in human to approval (2) Peptide, protein, nucleic acid based molecular entities and vaccines (3) From beginning of 2008 to end of 2011: Pentacel® (2008), Multaq® (2009), Jevtana® (2010) (4) Toujeo®, Afrezza®, Cerdelga®, Lemtrada®, Aubagio®, Zaltrap®, Kynamro®, Hexaxim®, Fluzone® Quadrivalent, Praluent® 2012 2015 Quality over Quantity(1) 79 projects 44 projects Prioritization Unprioritized Tiering system Biologics(2) 58% 85% External Innovation >65% >65% Early Development Fast to Market Fast to Proof of Concept Cycle Times Slower than industry median Faster than industry median R&D Budget ~14% of sales ~14% of sales Launches 3 launches since 2008(3) 10 launches since 2012(4) 4
  5. 5. Sustain Innovation in R&D 5 ● Sustain leadership: Diabetes/CV, Vaccines, Rare Diseases ● Build competitive positions: Oncology, MS, Immunology ● Invest opportunistically: Neurodegeneration/pain, Infectious Diseases and Ophthalmology Continue to strengthen R&D pipeline A C D B Deliver a Balanced Pipeline… … Focused on GBU Priorities Increasing annual R&D investments up to €6bn by 2020 while maintaining financial discipline Foster existing R&D collaborations (REGN, ALNY) Increase capacity for external innovation Implement the R&D 2.0 model
  6. 6. Global Roll-out Underway for Three Major Products ● Rapid market access obtained in the U.S.(1) ● Showing early promise in key markets ● U.S. uptake trending favorably compared to diabetes analogues(2) ● Launched globally in 20 countries ● Significant progress achieved recently in U.S. Market Access ● >170m Commercial and Medicare lives now covered ● ~40% exclusive and ~60% at parity ● ODYSSEY OUTCOMES interim efficacy analysis expected in H2 2016(3) ● Priority introduction in high endemic countries ● Approvals recently granted in Mexico, the Philippines, Brazil and El Salvador(4) ● Regulatory decisions pending in 16 additional countries ● Transitioning from licensures to vaccination campaigns in 2016 6 Praluent® is developed and commercialized in collaboration with Regeneron (1) As of January 1, 2016, 86% of commercial and 91% of Medicare lives covered (2) Toujeo® analogues include: Bydureon® (AstraZeneca), Farxiga® (AstraZeneca), Invokana® (J&J), Levemir® (Novo Nordisk), Tanzeum® (GlaxoSmithKline), Tresiba® (Novo Nordisk) and Trulicity® (Eli Lilly) (3) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred (4) The Mexican Federal Commission for the Protection against Sanitary Risks, Philippines' Food and Drug Administration, Brazilian regulatory authorities ANVISA and El Salvador Dirección Nacional de Medicamentos approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in individuals from 9-45 years of age living in endemic areas
  7. 7. 7 Sarilumab is developed in collaboration with Regeneron (1) Sanofi announced that the U.S. FDA accepted the lixisenatide NDA for review on September 29, 2015; lixisenatide was approved for treatment of Type 2 Diabetes in Europe in February 2013 (2) Sanofi announced that the U.S. FDA accepted the LixiLan NDA for review on February 22, 2016 (3) Sanofi and Regeneron announced that the U.S. FDA accepted the sarilumab BLA for review on January 8, 2016 Three Regulatory Filings for New Medicines Submitted  U.S. regulatory decision expected in August 2016(2)  EU regulatory filing in March 2016 on track Type 2 Diabetes Rheumatoid ArthritisType 2 Diabetes  U.S. regulatory decision expected in July 2016(1)  U.S. regulatory decision expected in Q4 2016(3)  EU regulatory filing expected in Q3 2016 lixisenatide
  8. 8. Positioning Sarilumab for Potential Success in the Rheumatoid Arthritis Biologic Market(1) 8 Sarilumab is developed in collaboration with Regeneron (1) Sarilumab is an investigational agent under clinical development and its safety and efficacy has not been fully evaluated by any Regulatory Authority (2) Two subcutaneous dosing options- 200 mg and 150 mg, every other week - for all patients (not weight based) (3) X-ray data demonstrating 90% inhibition of structural damage with 200 mg every 2 weeks SC dosing (4) Humira® (adalimumab) is an AbbVie brand (5) Biologics License Application submitted to the FDA in October 2015 ● IL-6 plays key roles in the local joint symptoms and systemic manifestations of rheumatoid arthritis (RA) ● Entering an €18bn RA market where unmet need is still high ● IL-6 class >€1bn in sales and growing >20% ● Unique profile features potential dosing flexibility(2) and impact on bone erosion(3) ● Positive Phase III data in methotrexate-inadequate responder (IR) and difficult-to-treat TNF-IR populations ● Phase 3 MONARCH monotherapy study vs. Humira® results expected in Q2 2016(4) ● U.S. regulatory decision expected in Q4 2016(5) ● E.U. submission anticipated in Q3 2016
  9. 9. MOBILITY: Sarilumab Inhibited Progression of Structural Damage 9 Sarilumab is developed in collaboration with Regeneron *p<0.0001, **p=0.003 (1) Change from Baseline in mTSS (Van der Heijde modified Total Sharp Score) (2) In the MOBILITY study, infections were the most frequently reported adverse events and were reported with a higher incidence in the sarilumab groups vs. placebo, all in combination with MTX (39.6% for 200 mg, 40.1% for the 150 mg group and 31.1% for pbo). The incidence of serious infections was 4.0% in the 200 mg + MTX group, 2.6% in the 150 mg + MTX group, and 2.3% in the placebo + MTX group. (3) Incidence ≥3% Q2W = every other week; SC = subcutaneous 0 1 2 3 0 4 8 12 16 20 24 28 32 36 40 44 48 52 90% * * 70% Placebo + MTX sarilumab 150 mg q2w + MTX sarilumab 200 mg q2w + MTX ** * ● X-ray data(1) demonstrating 90% inhibition of progression of structural damage with 200 mg Q2W SC dosing ● Safety profile consistent with mechanism of action(2) ● Most common adverse events(3) included neutropenia, increased ALT, and upper respiratory infections Change from Baseline in mTSS at Week 24 and Week 52
  10. 10. Fully Human IL-4Rα mAb Inhibiting Intracellular Signaling of Both IL-4 and IL-13 Dupilumab – A Pipeline in a Product with Multi-blockbuster Potential(1) Dupilumab is developed in collaboration with Regeneron Th2: T-helper 2 cells involved in “humoral-mediated” immunity (1) Dupilumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory agency 10 IL-4 IL-4Rα γc Type I Receptor Type II Receptor IL-13 IL-4Rα IL-13Rα1 or IL-4/IL-13 pathway may be a fundamental driver in these Th2-mediated allergic diseases Atopic Dermatitis ● Received “Breakthrough Therapy” designation by FDA ● SOLO 1 and 2 Phase III top line results expected in Q1 2016 ● CHRONOS Phase III interim results expected in Q2 2016 ● U.S. regulatory submission expected in Q3 2016 Asthma ● Phase III ongoing ● Completed Phase 2b trial considered pivotal by FDA Nasal Polyposis ● Start of Phase III expected in Q4 2016 Eosinophilic Esophagitis ● Phase II ongoing
  11. 11. ● Over 5 million people in the U.S. and EU(1) estimated to be affected by moderate-to-severe atopic dermatitis ● 40% of moderate-to-severe patients uncontrolled with topicals ● Characterized by eczematous dermatitis with intractable pruritus ● Negative impact on Quality of Life is underestimated ● Similar or higher than in psoriasis ● Greater risk for psychological distress including anxiety, depression and suicidal ideation(2,3,4) 11 Atopic Dermatitis Is a Serious, Chronic, Inflammatory Skin Condition 11 (1) Adapted from White Book on Allergy published in 2011, http://www.worldallergy.org/UserFiles/file/WAO-White-Book-on-Allergy_web.pdf (2) Journal of Psychomatic Research 57 (2004) 195-200 (3) Acta Derm Venereol 2004;84(3):205-12 (4) Suicide Life Threat Behav 2006 2006 Feb;36(1):120-4
  12. 12. Parameter Placebo 300mg q2w 300mg qw EASI Score(1) -18.1% -68.2% -73.7% 50/75/90 EASI Improvement(2) 29.5%/11.5%/3.3% 78.1%/53.1%/29.7% 82.5%/60.3%/36.5% IGA Response(3) 1.6% 29.7% 33.3% Pruritus NRS(4) -11.3% -52.9% -59.7% Dupilumab is developed in collaboration with Regeneron (1) Least–squares (LS) mean percent change in EASI (Eczema Area Severity Index) (2) Proportion of patients achieving EASI-50/70/90 (3) Proportion of patients achieving IGA ≤ 1 (Investigator’s Global Assessment score of 0 “clear” or 1 “almost clear”) (4) Overall weekly mean percent change in pruritus NRS (Numeric Rating Scale) (5) IGA response is the primary endpoint for the U.S. FDA regulatory filing; . IGA response and EASI-75 score are co-primary endpoints for regulatory filings in the EU and Japan. Dupilumab Significantly Improved Signs and Symptoms in Moderate-to-Severe AD Patients Uncontrolled by Topicals 300mg qw and 300mg q2w dose regimens being studied in Phase 3 program 12 p<0.0001 vs placebo for all parameters Phase IIb Study in AD - Change in Efficacy Endpoints at 16 Weeks Primary endpoint of Phase III studies(5)
  13. 13. Dupilumab Safety Findings in Moderate-to-Severe Atopic Dermatitis(1) 13 PlaceboDupilumab 32.3% 25.0% Nasopharyngitis PlaceboDupilumab 14.8% 7.7% Headache Dupilumab Placebo 9.5% 4.6% Injection site reactions ● Nasopharyngitis, the most common adverse event, balanced across dupilumab treatment groups vs. placebo ● Headache and injection site reactions more frequent with dupilumab Phase IIb Study Dupilumab is developed in collaboration with Regeneron (1) Final 32wk safety results from all dupilumab dose cohorts in the Phase 2b study presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD); San Francisco, CA, USA; March 20–24, 2015 26.2% 3.3% 3.3%
  14. 14. ● 235-300m people worldwide estimated to be affected by asthma(1) ● ~25m people in the U.S. alone ● 10 to 20% of patients uncontrolled despite existing therapies ● Chronic inflammatory disease leading to acute and chronic narrowing of the airway and increased mucus production ● Patients with asthma experience wheezing, shortness of breath, cough and chest tightness 14 Moderate-to-Severe Asthma Negatively Impacts the Lives of Patients and Is Associated with High Burden to Society 14 (1) WHO, http://www.who.int/mediacentre/factsheets/fs307/en/
  15. 15. Dupilumab Shows Improvement in Lung Function in Phase IIb in Moderate-to-Severe Asthma 15 Dupilumab is developed in collaboration with Regeneron FEV1=forced expiratory volume over one second During the treatment period, patients continue their stable medium- or high-dose inhaled corticosteroid and long-acting beta agonist (ICS/LABA) combination product Presented at the 25th Meeting of the European Respiratory Society (ERS); Amsterdam, The Netherlands; September 26–30, 2015 0 100 200 300 400 High Eosinophils Population Low Eosinophils Population Overall population Placebo 200mg Q2W 300mg Q2W 12.8% 22.9%(1) 24.9%(2) mL 16.6%(3) 17.3%(3) 7.0% (1) p<0.05 vs placebo (2) p<0.01 vs placebo (3) p<0.001 vs placebo Phase IIb - Mean Improvement in FEV1 at 24 Weeks (mL and % Change from Baseline) 13.4%(2) 12.6%(2) 4.7%
  16. 16. 16 Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb in Moderate-to-Severe Asthma 0,0 0,2 0,4 0,6 0,8 1,0 High Eosinophils Population Low Eosinophils Population Overall population Placebo 200mg Q2W 300mg Q2W Dupilumab is developed in collaboration with Regeneron During the treatment period, patients continue their stable medium- or high-dose inhaled corticosteroid and long-acting beta agonist (ICS/LABA) combination product Presented at the 25th Meeting of the European Respiratory Society (ERS); Amsterdam, The Netherlands; September 26–30, 2015 -81%(2) -71%(1) -68%(2) -60%(1) (1) p<0.05 vs placebo (2) p<0.01 vs placebo (3) p<0.001 vs placebo Phase IIb - Annualized Rate of Severe Exacerbation Events at 24 Weeks -70%(3) -70%(3) 1.0 0.8 0.6 0.4 0.2 0.0
  17. 17. 17 Dupilumab Safety Profile in Moderate-to-Severe Asthma PlaceboDupilumab 59.2% 52.0% Infections PlaceboDupilumab 10.2% 4.0% Severe AEs Dupilumab Placebo 26.9% 12.7% Injection site reactions ● Injection site reaction was the most common adverse event and was more frequent with dupilumab ● Other common adverse events in the study included upper respiratory tract infection, headache, nasopharyngitis and bronchitis ● Incidence of infections of serious adverse events was balanced across treatment groups Phase IIb Study Dupilumab is developed in collaboration with Regeneron Final 24wk safety results from all dupilumab dose cohorts in the Phase 2b study presented at the 25th Meeting of the European Respiratory Society (ERS); Amsterdam, The Netherlands; September 26–30, 2015 13.3% 5.7% 53.2%
  18. 18. 18 A Strong Profile Emerging from PoC Study Combining Lantus® with Lixisenatide in Type 2 Diabetes(1) Statistically significant A1c reduction More patients with A1c <7% FPG + PPG control Offsets weight gain versus insulin glargine No additional incidence of hypoglycemia Fixed Ratio Combination of Two Active Components Single Once Daily Injection = Full results from the LixiLan-O and LixiLan-L Phase III studies to be communicated at a medical congress in 2016, potentially at ADA PoC: Proof-of-concept; PPG: Post-Prandial Glucose; FPG: Fasting Plasma Glucose (1) Proof-of-concept study (323 patients): a 24-week randomized, open-label, trial comparing the efficacy and safety of insulin glargine/lixisenatide fixed ratio once-daily combination versus insulin glargine, in type 2 diabetes inadequately controlled with metformin
  19. 19. 19 Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements (1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidney SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney (2) Subject to customary closing conditions (3) LAPS CA-Exendin-4 analog T1DM: Diabetes mellitus type 1 Sotagliflozin - Phase II in T2 Diabetes Phase III in T1 Diabetes ● Dual SGLT1 and SGLT2 inhibitor(1) ● Limiting meal time glucose absorption and increasing renal glucose excretion ● Oral administration ● Adjunct therapy to insulin in T1DM ● Favorable safety profile Immunology Efpeglenatide – Phase II ● Long acting GLP-1(3) ● Diabetes/Obesity ● Weekly/monthly administration LAPS Insulin 115 (HM12470) – Phase I ● Long acting insulin ● Less side-effects (hypoglycemia, obesity) ● Weekly administration LAPS Insulin Combo – Pre-clinical ● Long acting insulin + efpeglenatide combination ● Weekly administration (2)
  20. 20. Dual Agonists for GLP-1 and Glucagon/GIP Receptors 20 ● Novel synthetic peptidic molecules developed in-house ● Expected benefit is blood glucose control with superior weight loss over pure GLP-1 receptor agonists ● Phase I study of dual GLP-1/Glucagon agonist in healthy volunteers recently completed ● Phase I study of dual GLP-1/GIP agonist recently started ● Of particular interest in overweight to obese people with T2D ● 60% of the T2D population -1.4%-1.2% ∆HbA1c vs. Placebo 0 2 4 6 8 10 Day -4 Day 28 Sanofi dual Agonist 4 µg/kg Liraglutide 40 µg/kg Placebo -7 -6 -5 -4 -3 -2 -1 0 1 2 3 0 5 10 15 20 25 30 Study days GLP-1/Glucagon Dual Agonist Glucose Control Similar to Liraglutide - Animal Data(1) GLP-1/Glucagon Dual Agonist Body Weight Loss Superior to Liraglutide (~5%) - Animal Data(1) Sanofi dual agonist 4 µg/kg Liraglutide 40 µg/kg Placebo %Bodyweightloss (comparedtoday-5)HbA1c(%) (1) 4 week study in obese, diabetic non-human primates comparing 4 µg/kg Sanofi dual agonist with 40 µg/kg liraglutide and vehicle (2-step uptitration to reach maintenance dose on day 6), data on file
  21. 21. ● Acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick Type B, is a lysosomal storage disorder, characterized by fat deposits in spleen and liver ● Patient identification uses established diagnosis algorithm for Gaucher ● ASMD diagnosis rate in the low to mid-single digits after testing negative for Gaucher Gaucher Hematology Campaign ASMD Patient Diagnosis Olipudase alfa – An Investigational Treatment for ASMD with FDA Breakthrough Therapy Designation(1,2) Therapeutic Approach Phosphorylcholine Ceramide Sphingosine Acid- Ceramidase Intended result: Reverse and prevent somatic disease if treatment begins early Target the underlying metabolic defect by replacing the missing enzyme Olipudase alfa 21 Sphingomyelin (1) Olipudase alfa is the recombinant form of human acid sphingomyelinase currently being developed as an enzyme replacement therapy (ERT). (2) The Breakthrough Therapy designation is supported by data from a completed Phase 1b study. The data on repeat-dose safety, pharmacodynamics, and exploratory efficacy support continued development for the investigational use in nonneurological manifestations of ASMD. Pivotal Phase II/III trial expected to start in Q2 2016
  22. 22. 22 TTR: transthyretin is the disease-causing protein in TTR-mediated amyloidosis; AT: antithrombin is a key endogenous anticoagulant (1) Sanofi has exclusive territory rights for the ALN-TTR programs outside North America and Western Europe (i.e., rest-of world (ROW) rights). In addition, Sanofi has co-development and co-commercialization rights for Revusiran in North America and Western Europe. Sanofi has elected presently to opt into the fitusiran program for its ROW rights. Sanofi retains its future opt-in right to co-develop and co- promote fitusiran with Alnylam in North America and Western Europe (2) Separate trials for patients with and without inhibitor antibodies against factor VIII or Factor IX replacement therapies patisiran RNAi therapeutic targeting transthyretin (TTR) ● Intravenous infusion revusiran RNAi therapeutic targeting transthyretin (TTR) ● Subcutaneous injection Phase III ongoing in TTR Amyloidosis - Familial Amyloidotic Cardiomyopathy Phase III ongoing in TTR Amyloidosis - Familial Amyloidotic Polyneuropathy Alnylam Collaboration Provides Access to Unique RNAi Opportunities(1) fitusiran RNAi therapeutic targeting antithrombin (AT) ● Subcutaneous injection Two Phase III trials in severe hemophilia A and B patients planned to start in Q3 and Q4 2016(2) ● World-class RNAi technology platform for rare genetic disease development ● Knockdown disease causing protein in the liver
  23. 23. Rebuilding a Competitive Position in Oncology 23 ● Maximize clinical assets, particularly isatuximab (anti-CD38 mAb) and Antibody-Drug Conjugates ● Recent collaborations to build a transformative pipeline ● Regeneron – Immuno-oncology strategic alliance ● BioNTech – mRNA therapeutics ● Innate Pharma – bispecific mAb NK cell engagers ● Warp Drive Bio – novel oncology therapies and antibiotics ● Evotec and Apeiron Biologics – novel immuno-oncology small molecules ● Rebuild critical mass Oncology Opportunity Largest therapeutic area for pharmaceuticals Strong growth driven by unmet need and groundbreaking science 1 2 3
  24. 24. MTD: Maximum Tolerated Dose (1) Patients on monotherapy study had a median of 4 prior lines of treatment and all patients received IMiD and a proteasome inhibitor; Majority (66%) received pomalidomide or carfilzomib (2) Patients in combination study had median of 7 prior lines of treatment (74% refractory to prior Revlimid/dexamethasone and 81% refractory to IMiDs) HDeckert, et al. Clin Cancer Res 2014;20:4574–83. MOA: Mechanisms of action (3) 52% of the patients experienced IARs with 3% of patients with IARs of grade 3/ 4. Pre-treatment prophylaxis used for all patients. 24 ● Multiple Myeloma remains incurable ● 50,000 patients are diagnosed annually in the U.S. and Europe ● Encouraging efficacy in heavily pre-treated myeloma patients(1) ● Targets unique epitope possibly differentiating MoA(2) ● Manageable safety profile ● MTD not reached in single agent and combination ● Infusion reactions mainly cycles 1 & 2 and majority are Grade 1-2(3) ● No overlapping toxicity in combination with Revlimid® ● Monotherapy dose ranging study completed Isatuximab (anti-CD38 mAb): a Significant Opportunity to Potentially Address an Unmet Need in Multiple Myeloma Phase III expected to start in Q4 2016
  25. 25. 25 New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of IO Establish Sanofi’s presence in cancer immunotherapy, a rapidly growing and attractive segment of oncology  Significant unmet needs remain despite advances shown with checkpoint inhibitors PD-1: Programmed death protein 1 LAG-3: Lymphocyte activation gene 3 IO: Immuno-Oncology (1) Including bi-specifics/multi-specifics antibodies (2) REGN2810 Entering Immuno-Oncology 1 2 3 Expand oncology pipeline, developing potentially best-in-class new antibodies(1) and novel combination therapies  Alliance includes PD-1(2) in Phase I and a portfolio of antibodies, including GITR and LAG3, with the first of these entering Phase I in 2016 Enable development of multiple assets in a fast-evolving IO space with a scale and focus beyond our existing discovery agreement
  26. 26. 26 2016 Will Be a Busy Year for R&D Pipeline News Flow 26 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Dengvaxia® in endemic countries ● Lixisenatide in Diabetes (U.S.)  ● LixiLan in Diabetes (U.S.)  ● Sarilumab in Rheumatoid Arthritis (U.S.)  Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● LixiLan in Diabetes (E.U.)  ● Dupilumab in Atopic Dermatitis (U.S.)  Expected Phase III / IIIb Topline Data Q1 Q2 Q3 Q4 ● Dupilumab in Atopic Dermatitis (SOLO 1 & 2 / CHRONOS)   ● Insulin lispro in Diabetes (SORELLA )  ● Sarilumab in Rheumatoid Arthritis (MONARCH)  ● Praluent® ODYSSEY OUTCOMES 2nd interim analysis(1) Expected Phase III Starts Q1 Q2 Q3 Q4 ● Olipudase alfa in Niemann Pick type B(2)  ● NeoGAA in Pompe  ● Fitusiran in Hemophilia  ● Efpeglenatide in Diabetes  ● Sotagliflozin in Diabetes  ● Isatuximab in Multiple Myeloma  (1) Interim analysis for futility when ~50% of events have occurred; second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016 (2) Pivotal phase II/III trial

×