Author: Lucy J. Sannes, PhD, MBA
CHAPTER 1
INTRODUCTION
1.1. The Immune System
1.2. Scope of the Report
CHAPTER 2
ALZHEIMER’S DISEASE
2.1. Alzheimer’s Disease Pathophysiology, Epidemiology, and Current Treatments
2.2. Why Immunotherapies or Vaccines for Treatment of Alzheimer’s Disease?
2.3. Companies Developing Immunotherapies or Vaccines for Alzheimer’s Disease
AFFiRiS’ AFFITOPE AD01 and AFFITOPE AD02
Baxter’s GAMMAGARD
Novartis’ and Cytos Biotechnology’s CAD106
Eli Lilly’s LY2062430
Genentech’s and AC Immune’s Anti-Abeta
GlaxoSmithKline’s GSK933776A
JANSSEN Alzheimer Immunotherapy’s (Part of Johnson &
Johnson) and Pfizer’s Bapineuzumab
Merck & Co.’s V950
Octapharma’s Octagam
Pfizer’s PF-4360365
Roche’s and MorphoSys’ RG1450
2.4. Business Considerations: Immunotherapies for Alzheimer’s Disease
CHAPTER 3
ADDICTION
3.1. Pathophysiology, Epidemiology, and Current Treatments
Cocaine Addiction
Nicotine Addiction (Smoking Cessation)
3.2. Why Immunotherapies for Addiction?
3.3. Companies Developing Immunotherapies for Cocaine Addiction or
Smoking Cessation
Cocaine Addiction
Celtic Pharma’s TA-CD
Nicotine Addiction (Smoking Cessation)
Celtic Pharma’s TA-NIC
Nabi Biopharmaceuticals’ NicVAX
Novartis’ and Cytos Biotechnology’s NIC002
3.4. Business Considerations: Immunotherapies for Cocaine Addiction or Smoking Cessation
CHAPTER 4
OTHER NEUROLOGY INDICATIONS OF MONOCLONAL
ANTIBODIES AND IMMUNOTHERAPIES
4.1. Pathophysiology, Epidemiology, and Current Treatment
Multifocal Motor Neuropathy
Pain
Post-Polio Syndrome
Other Potential Neurology Indications
4.2. Why Immunotherapies for Treatment of Pain?
4.3. Companies Developing or Marketing Immunotherapies for Other Neurological Indications
Alexion Pharmaceuticals’ Soliris (eculizumab)
Array BioPharma’s ARRY-797
Baxter’s Immune Globulin
CSL Behring’s Immune Globulin
GlaxoSmithKline’s 249320 (GSK249320)
Pfizer’s Tanezumab
Pharmalink’s Xepol (XP-28)
Talecris Biotherapeutics’ Gamunex
4.4. Business Considerations: Immunotherapies for Other Neurological Indications
CHAPTER 5
CARDIOVASCULAR DISEASES INCLUDING THROMBOSIS
5.1. Pathophysiology, Epidemiology, and Current Treatment
Angina
Atherosclerosis
Dyslipidemia (Elevated Cholesterol and Other Lipids)
Hypertension
Venous Thromboembolism
Digoxin Toxicity
5.2. Why Immunotherapies for Selected Cardiovascular Diseases?
5.3. Companies Developing Immunotherapies for Cardiovascular Diseases
Ablynx’ ALX-0081 and ALX-0681
BTG’s DigiFab
BTG’s Angiotensin Therapeutic Vaccine
Centocor Ortho Biotech’s and Eli Lilly’s ReoPro (abciximab)
Cytos Biotechnology’s CYT006-AngQb
Genentech’s and BioInvent International’s Anti-oxLDL (BI-204)
GlaxoSmithKline’s Digibind
Roche’s and Genmab’s RG1512
ThromboGenics’ and BioInvent International’s TB-402
5.4. Business Considerations: Immunotherapies for Cardiovascular Diseases
CHAPTER 6
HEMATOLOGY/BLOOD DISORDERS
6.1. Pathophysiology, Epidemiology, and Current Treatments
Idiopathic (Immune) Thrombocytopenic Purpura (ITP)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Rh Incompatibility and Hemolytic Disease of the Newborn (HDN)
6.2. Why Immunotherapies for Selected Hematology/Blood Disorders?
6.3. Companies Developing or Marketing Immunotherapies for
Hematology/Blood Disorders
Amgen’s Nplate (romiplostim)
Immune Globulin Preparations for Idiopathic (Immune)
Thrombocytopenic Purpura (ITP)
Rho(D) Immune Globulin Preparations and LFB’s Anti-Rhesus D
Monoclonal Antibody
6.4. Business Considerations: Immunotherapies for Hematology/Blood Disorders
CHAPTER 7
OPHTHALMOLOGY
7.1. Pathophysiology, Epidemiology, and Current Treatments
Age-Related Macular Degeneration (AMD)
Diabetic Retinopathy and Diabetic Macular Edema
Retinal Vein Occlusion
Uveitis
7.2. Why Antibody-Based Therapies for Selected Ophthalmic Diseases?
7.3. Companies Developing Antibody-Based Therapies for Ophthalmic Diseases
ESBATech’s ESBA105
Genentech’s and Novartis’ Lucentis (ranibizumab)
Lpath’s iSONEP (sonepcizumab)
7.4. Business Considerations: Antibody-Based Therapies for Ophthalmic Diseases
CHAPTER 8
OSTEOPOROSIS AND OTHER BONE METABOLISM DISORDERS
8.1. Pathophysiology, Epidemiology, and Current Treatments
8.2. Why Antibodies for Selected Bone Metabolism Diseases?
8.3. Companies Developing Antibodies for Osteoporosis and Other Bone Metabolism Disorders
Ablynx’ ALX-0141
Amgen’s Prolia (denosumab)
Amgen’s and UCB Pharma’s Sclerostin Ab
8.4. Business Considerations: Antibodies for Osteoporosis and Other Bone Metabolism Disorders
CHAPTER 9
TYPE 2 DIABETES
9.1. Pathophysiology, Epidemiology, and Current Treatments
9.2. Why Monoclonal Antibodies for Type 2 Diabetes?
9.3. Companies Developing Monoclonal Antibodies for Type 2 Diabetes
Amgen’s AMG 477
Cytos Biotechnology’s CYT013-IL1bQb
Novartis’ Ilaris (canakinumab)
Xoma’s XOMA 052
9.4. Business Considerations: Monoclonal Antibodies for Type 2 Diabetes
CHAPTER 10
OTHER APPLICATIONS OF ANTIBODIES AND
IMMUNOTHERAPIES
10.1. Companies Developing Antibodies, Antibody-Based Drugs, and Anti-inflammatory Drugs for Other Indications 153
Drugs for Selected Other Indications
Amgen’s AMG 745
AstraZeneca’s and BTG’s CytoFab
BTG’s CroFab and ViperaTAb
ESBATech’s ESBA105
FibroGen’s FG-3019
Genzyme’s GC1008
GlaxoSmithKline’s 656933 (Sb656933)
Novartis’ Ilaris (canakinumab)
Immune Globulin Preparations for Other Indications
10.2. Business Considerations: Antibodies and Immunotherapies for Other Indications
CHAPTER 11
EXPERT INTERVIEWS 165
11.1. Steven Glazer, MD; Senior Vice President, Development; BioInvent International
11.2. Josefin-Beate (Josi) Holz, MD, Chief Medical Officer & Eva-Lotta Allan, Chief Business Officer; Ablynx
11.3. David Y. Liu, PhD, Vice President, Research & William Hodder, Vice President, Business Development; FibroGen
11.4. Steve Pakola, MD; Chief Medical Officer; ThromboGenics
11.5. Andrea Pfeifer, PhD; Chief Executive Officer; AC Immune
11.6. Roger Sabbadini, PhD; Founder, Vice President, Chief Scientific Officer; Lpath
11.7. Walter Schmidt, PhD; Chief Executive Officer; AFFiRiS
REFERENCES
COMPANY INDEX WITH WEB ADDRESSES