As of May 1, 2018
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Pfizer Pipeline As of May 1, 2018 Disclaimer ● As some programs are still confidential, some candidates may not be identified in this list. In these materials, Pfizer discloses Mechanism of Action (MOA) information for some candidates in Phase 1 and for all candidates from Phase 2 through regulatory approval. With a view to expanding the transparency of our pipeline, Pfizer is including new indications or enhancements, which target unmet medical need or represent significant commercial opportunities. The information contained on these pages is correct as of May 1, 2018. ● Visit Pfizer.com/pipeline, Pfizer’s online database where you can learn more about our portfolio of new medicines and find out more about our Research and Development efforts around the world. 2 Table of Contents Pfizer Pipeline Snapshot 4 Inflammation and Immunology 5 Metabolic Disease and Cardiovascular Risks 6 Oncology 7-9 Rare Diseases 10 Vaccines 11 Biosimilars and Other Areas of Focus 12 Projects Discontinued Since Last Update 13 Backup: Regulatory Designation Definitions 14-15 3 * A portion of the increase in the number of projects in Phase 1 and Phase 2 Pfizer Pipeline Snapshot between the January 30, 2018 and May 1, 2018 updates is attributable to a change in project counting Pfizer Pipeline 10 programs advanced practices. Multiple Snapshot as of indications previously or are new combined and reflected as a Discovery May 1, 2018 single project are now being Projects counted separately. This change has been Phase 1 * Phase 2 * Phase 3 Registration Total implemented to increase 34 22 28 12 96 transparency and provide a more comprehensive view of our early and mid-stage portfolio. Recent Approvals Pipeline represents progress of R&D - Bosulif (bosutinib) for 1st Line Chronic Myelogenous Leukemia (EU) programs as of May 1, 2018 8 projects discontinued since - Mylotarg (gemtuzumab ozogamicin) for 1st Line Acute Myeloid Leukemia Included are 49 NMEs, 39 additional last update (EU) indications, plus 8 biosimilars - Steglatro (ertugliflozin) and Fixed-Dose Combinations Steglujan (ertugliflozin and sitagliptin) and Segluromet (ertugliflozin and metformin HCL) for Adults with Type 2 Diabetes (EU) 10 programs advanced Pfizer Pipeline or are new Snapshot as of Discovery January 30, 2018 Projects Phase 1 Phase 2 Phase 3 Registration Total 30 18 29 10 87 Pipeline represents progress of R&D Recent Approvals programs as of January 30, 2018 - Bosulif (bosutinib) for 1st Line Chronic Myelogenous Leukemia (US) Included are 56 NMEs, 24 additional 14 projects discontinued since - IXIFI (PF-06438179, infliximab-qbtx), as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product (US) indications, plus 7 biosimilars last update - Steglatro (ertugliflozin) and Fixed-Dose Combinations Steglujan (ertugliflozin and sitagliptin) and Segluromet (ertugliflozin and metformin HCL) for Adults with Type 2 Diabetes (US) - Sutent (sunitinib) for Adjuvant Treatment of Renal Cell Carcinoma (US) - Xeljanz (tofacitinib) and Xeljanz XR for Psoriatic Arthritis (US) 4 New Molecular Entity New Indication or Pfizer Pipeline – May 1, 2018 Enhancement Therapeutic Area Compound Name Mechanism of Action Indication Phase Modified Release 11mg Tablet for ►Xeljanz (tofacitinib) JAK Inhibitor Registration Rheumatoid Arthritis (E.U.) Xeljanz (tofacitinib) JAK Inhibitor Ulcerative Colitis Registration Xeljanz (tofacitinib) JAK Inhibitor Psoriatic Arthritis (E.U.) Registration PF-04965842 JAK Inhibitor Atopic Dermatitis (BREAKTHROUGH) Phase 3 Dekavil IL-10 Rheumatoid Arthritis (Biologic) Phase 2 PF-06480605 TNFSF15 Blocker Ulcerative Colitis (Biologic) Phase 2 PF-06650833 IRAK4 Rheumatoid Arthritis Phase 2 PF-06651600 JAK3 Alopecia Areata Phase 2 PF-06651600 JAK3 Rheumatoid Arthritis Phase 2 PF-06651600 JAK3 Ulcerative Colitis Phase 2 Inflammation and ►PF-06651600 JAK3 Crohn's Disease Phase 2 Immunology PF-06700841 TYK2/JAK1 Alopecia Areata Phase 2 PF-06700841 TYK2/JAK1 Psoriasis Phase 2 PF-06700841 TYK2/JAK1 Ulcerative Colitis Phase 2 ►PF-06700841 TYK2/JAK1 Crohn's Disease Phase 2 Dekavil IL-10 Inflammatory Bowel Disease (Biologic) Phase 1 interleukin 7 receptor precursor PF-06342674 Diabetes Mellitus-Type 1 (Biologic) Phase 1 Modulator PF-06817024 Cytokine Modulator Atopic Dermatitis (Biologic) Phase 1 interferon, beta 1, fibroblast PF-06823859 Lupus (Biologic) Phase 1 (IFNB1) Blocker PF-06826647 TYK2 Inhibitor Inflammatory Bowel Disease Phase 1 PF-06835375 chemokine inhibitor Lupus (Biologic) Phase 1 ►Indicates that the project is either new or has progressed in phase since Indicates Regulatory Designation – See Definitions in Backup the previous portfolio update of Pfizer.com 5 New Molecular Entity Pfizer Pipeline – May 1, 2018 (cont’d) Therapeutic Area Compound Name Mechanism of Action Indication Phase Acetyl CoA-Carboxylase (ACC) Non-Alcoholic Steatohepatitis (NASH) PF-05221304 Phase 2 Inhibitor (FAST TRACK) Metabolic Disease PF-06835919 Ketohexokinase (KHK) Inhibitor Non-Alcoholic Steatohepatitis (NASH) Phase 2 and Diacylglycerol O-Acyltransferase 2 Cardiovascular Risks PF-06865571 Non-Alcoholic Steatohepatitis (NASH) Phase 1 (DGAT2) Inhibitor Glucagon-like peptide 1 receptor PF-06882961 Diabetes Mellitus-Type 2 Phase 1 (GLP-1R) Agonist Indicates Regulatory Designation – See Definitions in Backup 6 New Molecular Entity New Indication or Pfizer Pipeline – May 1, 2018 (cont’d) Enhancement Therapeutic Area Compound Name Mechanism of Action Indication Phase 1st Line EGFR-activating mutant Non-Small ►dacomitinib (PF-00299804) pan-HER Inhibitor Cell Lung Cancer (ORPHAN - U.S., PRIORITY Registration REVIEW) 2nd Line ALK Non-Small Cell Lung Cancer ►lorlatinib (PF-06463922) ALK Inhibitor (BREAKTHROUGH, ORPHAN - U.S., Registration PRIORITY REVIEW) Sutent (sunitinib) Multiple Tyrosine Kinase Inhibitor Renal Cell Carcinoma Adjuvant (E.U.) Registration Non-metastatic Castrate Resistant Prostate ►Xtandi (enzalutamide) Androgen receptor inhibitor Registration Cancer (PRIORITY REVIEW) 2nd Line Non-Small Cell Lung Cancer Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 3 (Biologic) 1st Line Non-Small Cell Lung Cancer Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 3 (Biologic) Oncology Bavencio (avelumab) Anti PD-L1 Inhibitor 1st Line Gastric Cancer (Biologic) Phase 3 (1 of 3) Platinum Resistant/Refractory Ovarian Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 3 Cancer (Biologic) Bavencio (avelumab) Anti PD-L1 Inhibitor 1st Line Ovarian Cancer (Biologic) Phase 3 Bavencio (avelumab) Anti PD-L1 Inhibitor 1st Line Urothelial Cancer (Biologic) Phase 3 1st Line Renal Cell Carcinoma (Biologic) Bavencio (avelumab) Anti PD-L1 Inhibitor (Combo w/ Inlyta (axitinib)) Phase 3 (BREAKTHROUGH) Locally Advanced Squamous Cell Carcinoma Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 3 of the Head and Neck (Biologic) Ibrance (palbociclib) CDK 4,6 Kinase Inhibitor High Risk Early Breast Cancer Phase 3 ►Indicates that the project is either new or has progressed in phase since Indicates Regulatory Designation – See Definitions in Backup the previous portfolio update of Pfizer.com 7 New Molecular Entity New Indication or Pfizer Pipeline – May 1, 2018 (cont’d) Enhancement Therapeutic Area Compound Name Mechanism of Action Indication Phase Ibrance (palbociclib) CDK 4,6 Kinase Inhibitor Early Breast Cancer in Adjuvant Setting Phase 3 Ibrance (palbociclib) CDK 4,6 Kinase Inhibitor HER2+ Breast Cancer Phase 3 Acute Myeloid Leukemia (ORPHAN - U.S., ►glasdegib (PF-04449913) SMO (smoothened) antagonist Phase 3 E.U.) 1st Line ALK Non-Small Cell Lung Cancer lorlatinib (PF-06463922) ALK Inhibitor Phase 3 (ORPHAN - U.S.) Germline BRCA Mutated Metastatic Breast talazoparib (MDV3800) PARP inhibitor Phase 3 Cancer 1st Line Metastatic Castration-Resistant talazoparib (MDV3800) PARP inhibitor Phase 3 Prostate Cancer Metastatic Hormone Sensitive Prostate Xtandi (enzalutamide) Androgen receptor inhibitor Phase 3 Cancer Non-metastatic High Risk Hormone Xtandi (enzalutamide) Androgen receptor inhibitor Phase 3 Sensitive Prostate Cancer Oncology 1st Line Merkel Cell Carcinoma (E.U.) (2 of 3) Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 2 (Biologic) Combo w/ PF-04518600 (OX40) for: Bavencio (avelumab) Anti PD-L1 Inhibitor Squamous Cell Carcinoma of the Head and Phase 2 Neck (Biologic) Combo w/ PF-05082566 (4-1BB) for: Melanoma, Non-Small Cell Lung Cancer, Bavencio (avelumab) Anti PD-L1 Inhibitor Small Cell Lung Cancer, Squamous Cell Phase 2 Carcinoma of the Head and Neck, Triple- Negative Breast Cancer (Biologic) 2nd Line Metastatic Castration-Resistant talazoparib (MDV3800) PARP inhibitor Phase 2 Prostate Cancer Combo w/ PF-04518600 (OX40) and PF- Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 1 05082566 (4-1BB) for: Cancer (Biologic) Combo w/ talazoparib (MDV3800) for: Solid Bavencio (avelumab) Anti PD-L1 Inhibitor Phase 1 Tumors (Biologic) ►Indicates that the project is either new or has progressed in phase since Indicates Regulatory Designation – See Definitions in Backup the previous portfolio update of Pfizer.com 8 New Molecular Entity New Indication or Pfizer Pipeline – May 1, 2018 (cont’d) Enhancement Therapeutic Area Compound Name Mechanism of Action Indication Phase Bavencio (avelumab) Anti PD-L1 Inhibitor Cancer (Biologic) Phase 1 Phosphatidyl inositol-3 kinase catalytic sub-unit α inhibitor / gedatolisib (PF-05212384) Cancer Phase 1 mammalian target of rapamycin inhibitor (PI3K/mTOR) glasdegib (PF-04449913) SMO (smoothened) antagonist Cancer Phase 1 Ibrance (palbociclib) CDK 4,6 Kinase Inhibitor Cancer Phase