Pfizer Pipeline. As of August 9, 2013

Transcription

1 Pfizer Pipeline As of August 9, 2013

2 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 candidates from 3 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 August 9, 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

3 Table of Contents Pfizer Pipeline Snapshot 4 Cardiovascular & Metabolic Diseases 5 Inflammation & Immunology 6 Neuroscience & Pain 7 Oncology 8 Vaccines 9 Other Areas of Focus (including Biosimilars and Rare Diseases) 10 Projects Discontinued Since Last Update 11 3

4 Pfizer Pipeline Snapshot Discovery Projects 7 programs advanced or are new Pfizer Pipeline Snapshot as of August 9, In Reg Total 76 Pipeline represents progress of R&D programs as of August 9, 2013 Included are 55 NMEs, 17 additional indications, plus 4 biosimilars 4 projects discontinued since last update Discovery Projects 2 programs advanced or are new Pfizer Pipeline Snapshot as of May 9, In Reg Total 74 Pipeline represents progress of R&D programs as of May 9, 2013 Included are 56 NMEs, 16 additional indications, plus 2 biosimilars 4 projects discontinued since last update Recent Approval - Bosulif for Treatment of Previously Treated Chronic Myelogenous Leukemia (EU) 4

5 Pfizer Pipeline August 9, 2013 Therapeutic Area Cardiovascular and Metabolic Diseases Compound Name Mechanism of Action ( 3 through regulatory approval) Eliquis (apixaban) Factor Xa Inhibitor Venous Thromboembolism Prevention (U.S.) Registration Eliquis (apixaban) Factor Xa Inhibitor Venous Thromboembolism Treatment 3 ertugliflozin (PF ) Diabetes Mellitus-Type 2 2 RN316 (PF ) Hypercholesterolemia (Biologic) 2 PF Diabetes Mellitus-Type 2 2 PF Diabetic Nephropathy 2 PF Diabetic Nephropathy 2 PF Diabetes Mellitus-Type 2 (Biologic) 1 PF Diabetes Mellitus-Type 2 1 RN317 (PF ) Hypercholesterolemia (Biologic) 1 PF Acute Coronary Syndrome 1 PF Diabetes Mellitus-Type 2 1 New or Enhancement Indicates that the project is either new or has progressed in phase since the previous portfolio update of Pfizer.com 5

6 Pfizer Pipeline August 9, 2013 (cont d) Therapeutic Area Compound Name Mechanism of Action ( 3 through regulatory approval) Xeljanz (tofacitinib) JAK Inhibitor Psoriasis (Oral) 3 Xeljanz (tofacitinib) JAK Inhibitor Ulcerative Colitis 3 Xeljanz (tofacitinib) JAK Inhibitor Psoriatic Arthritis 3 PF Rheumatoid Arthritis 2 PF Ulcerative Colitis (Biologic) 2 anrukinzumab (IMA-638) Ulcerative Colitis (Biologic) 2 Inflammation and Immunology PF Crohn s Disease, Ulcerative Colitis (Biologic) 2 PF Crohn s Disease, Lupus (Biologic) 2 PH Chronic Obstructive Pulmonary Disease 2 PD Sarcoidosis, *Lupus (Biologic) 2 PF (EXC 001) Dermal Scarring 2 Xeljanz (tofacitinib) Ankylosing Spondylitis, Psoriasis (Topical), Crohn s Disease 2 Dekavil Rheumatoid Arthritis (Biologic) 1 PF Chronic Obstructive Pulmonary Disease 1 PF Diabetes Mellitus-Type 1 (Biologic) 1 PF Lupus 1 New or Enhancement * Note: Additional indications in 1 Indicates that the project is either new or has progressed in phase since the previous portfolio update of Pfizer.com 6

7 Pfizer Pipeline August 9, 2013 (cont d) Therapeutic Area Compound Name Mechanism of Action ( 3 through regulatory approval) Celebrex COX-2 Chronic Pain (U.S.) Registration Remoxy ALO-02 Oxycodonenaltrexone core Mu-type opioid receptor (MOR-1) Agonist Mu-type opioid receptor (MOR-1) Agonist Moderate to Severe Pain (U.S.) Registration Moderate to Severe Pain 3 Lyrica Alpha-2 Delta Ligand Peripheral Neuropathic Pain 3 Lyrica Alpha-2 Delta Ligand CR (once a day dosing) 3 tanezumab Nerve Growth Factor Inhibitor OA Signs and Symptoms 3 Neuroscience & Pain PF (SAM-760) Alzheimer s Disease 2 PF Stroke Recovery 2 PF (ponezumab) Cerebral Amyloid Angiopathy (Biologic) 2 tanezumab Cancer Pain (Biologic) 2 PF Chronic Pain 1 PF (AAB-003) Alzheimer s Disease (Biologic) 1 PF Schizophrenia 1 PF Chronic Pain 1 PF Acute and Chronic Pain 1 New or Enhancement Indicates that the project is either new or has progressed in phase since the previous portfolio update of Pfizer.com 7

8 Pfizer Pipeline August 9, 2013 (cont d) Therapeutic Area Compound Name Mechanism of Action ( 3 through regulatory approval) dacomitinib (PF ) pan-her Inhibitor Previously Treated Advanced Non-Small Cell Lung Cancer 3 dacomitinib (PF ) pan-her Inhibitor 1 st Line Non-Small Cell Lung Cancer 3 Xalkori (crizotinib) c-met-alk Inhibitor ALK-Positive 1st and 2nd Line (supports potential full approval in the U.S.) Non- Small Cell Lung Cancer, *Cancer 3 Inlyta (axitinib) VEGF Tyrosine Kinase Inhibitor Renal Cell Carcinoma Adjuvant (Asia only) 3 Sutent Multiple Tyrosine Kinase Inhibitor Renal Cell Carcinoma Adjuvant 3 palbociclib (PD ) CDK 4,6 Kinase Inhibitor 1 st Line Advanced Breast Cancer, *Cancer 3 inotuzumab ozogamicin CD22-targeted cytotoxic agent Acute Lymphoblastic Leukemia (Biologic) 3 Oncology Inlyta (axitinib) Liver Cancer 2 dacomitinib (PF ) Cancer 2 PF Endometrial Cancer, *Cancer 2 PF Cancer 1 PF PD nd Line Hepatocellular Carcinoma (Biologic) Cancer (in combination with PF ) 1 1 PF Cancer (Biologic) 1 PF Acute Myelocytic Leukemia 1 New or Enhancement * Note: Additional indications in 1 8

9 Pfizer Pipeline August 9, 2013 (cont d) Therapeutic Area Compound Name Mechanism of Action ( 3 through regulatory approval) Vaccines MnB rlp2086 (PF ) 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) (PF ) Adolescent and Young Adult Meningitis B 3 Staph Aureus 2 PF Smoking Cessation 1 PF Clostridium Difficile Colitis 1 PF Asthma 1 9

10 Pfizer Pipeline August 9, 2013 (cont d) Therapeutic Area Compound Name Mechanism of Action ( 3 through regulatory approval) Other Areas of Focus (Rare Diseases) Other Areas of Focus (Biosimilars) Other Areas of Focus tafamidis meglumine rivipansel (GMI-1070) Transthyretin (TTR) Dissociation Inhibitor Transthyretin familial amyloid polyneuropathy (U.S.) Vaso-occlusive crisis associated with Sickle Cell Disease Registration 2 PF Hemophilia (Biologic) 1 PF Muscular Dystrophies (Biologic) 1 PF Spinal Muscular Atrophy 1 PF Rheumatoid Arthritis (Biosimilar) 1 PF Metastatic Breast Cancer (Biosimilar) 1 PF Rheumatoid Arthritis (Biosimilar) 1 PF Rheumatoid Arthritis (Biosimilar) 1 bazedoxifeneconjugated estrogens Tissue Selective Estrogen Complex Menopausal Vasomotor Symptoms (U.S.) / (EU) Registration Viviant Selective Estrogen Receptor Modulator Osteoporosis Treatment and Prevention (U.S.) Registration Zithromax/chloroquine 5-OS Ribosome Inhibitor Malaria 3 bosutinib Autosomal Dominant Polycystic Kidney Disease 2 New or Enhancement Biosimilar Indicates that the project is either new or has progressed in phase since the previous portfolio update of Pfizer.com 10

11 Projects Discontinued from Development since May 9, 2013 Compound Name Mechanism of Action ( 3 through regulatory approval) tofacitinib JAK Inhibitor Rheumatoid Arthritis (EU) 1 Registration inotuzumab ozogamicin Aggressive Non-Hodgkin Lymphoma (Biologic) 3 ACC-001 (PF ) Alzheimer s Disease 2 2 PNU Tuberculosis 2 1. We plan to work with the EMA to determine what additional data will be needed in order to resubmit a Marketing Authorization Application (MAA), and anticipate this will result in a several year delay. 2. Two ACC-001 PET imaging trials that are ongoing in the US will continue as planned since these clinical trials are collecting additional biomarker data in mild to moderate AD and in subjects with early Alzheimer sdisease. 11