Current Drug Development Market for Cytokines, Chemokines and Growth Factors

SUMMARY

D&MD's Current Drug Development Market for Cytokines, Chemokines and Growth Factors focuses primarily on the cytokine market, company pipelines and trials in the field of cytokine research. This report succinctly details all the latest advances in the push to market of cytokine-based therapeutics: which products have evolved, which have failed and new players on the field. Primary readers will have comprehensive updates on relevant company pipelines.

TABLE OF CONTENTS

CHAPTER 1: EXECUTIVE SUMMARY

CHAPTER 2: CYTOKINES

• Future Cytokine Modifications
  • Approved Therapeutic Biologics by CBER are Prerdominantly Cytokines or Growth Factor Related
  • The Biosimilar Debate
• Gene Therapy with Cytokines
  • Antisense and RNA Interference Technologies
• Interferons
  • Interferons (Avonex, Betaseron, Rebif) in the Multiple Sclerosis Multi-Billion Dollar Market
  • Interferon-based Drugs Being Developed for Immune Mediated Diseases
  • Interferons and Cancer
  • Interferons and Autoimmune Diseases such as Lupus, Asthma, and Crohn's Disease
  • New Interferons and Interferon Inducers in Viral Hepatitis
  • Interferon Mimetics and Variants
• Interleukins
  • Interleukin 1 and Autoimmunity
  • IL-2 and Cancer
  • IL 6-Tocilizumab for Treatment of Castleman's Disease
  • IL10, IL-11, IL-12, and IL-13 for Immune Cell Modulation
  • IL-21 and Its Receptor in Cancer Models of Mice
  • IL-1 and Autoimmune Disease (Rheumatoid Arthiritis, Psoriasis)
  • IL -4 Receptor and IL-5 in Asthma
  • IL-8's Pathological Role in Psoriasis
  • IL-12, IL-13, IL-17, and IL-18 in TH1 Mediated Autoimmunity
  • Interleukins and Infection
• The Interferon and Interleukin Market

CHAPTER 3: TARGETING THE CYTOKINE TNF LIGAND AND RECEPTOR SUPERFAMILIES

• TNF-α Inhibitors: FDA-Approved and Follow-ons
  • Enbrel (Etanercept)
  • Remicade (Infliximab)
  • Golimumab (CNTO 148)
  • Humira (Adalimumab)
  • Cimzia (Certolizumab Pegol)
• Additional TNF-α Antibody Inhibitors in Autoimmunity and Inflammation
  • Nano- and Diabodies
  • TNF-α Vaccines
• TNF-α Antagonists and Modifiers
  • TNF-α Gene Therapy
• Tumor Necrosis Factor-α in Cancer and Infection
• TNF-β (Lymphotoxin-β) (Lymphotoxin-α) TNF Receptor/Ligand Superfamily Member1) and
• Lymphotoxin-β (TNF Receptor/Ligand Superfamily Member 3)
• TNF Receptor/Ligand Superfamily
  • OX40/OX40L
  • CD40/CD40L
  • Fas/FasL
  • CD27/CD70
  • CD30/CD30L
  • 4-1BB (CD137)/ 4-1BBL
  • TRAIL Receptors/Ligands
  • RANK Receptor/Ligand
  • TWEAK/DR3
  • BLyS and APRIL
• TNF Market Opportunities

CHAPTER 4: CHEMOKINES AND DRUG DEVELOPMENT

• Chemokines and Their Receptors
  • CC Chemokines
  • CXC Chemokines
  • C Chemokines
  • CX3C Chemokines
• Chemokines and Autoimmune Disease
  • CCR9 Chemokine Receptor
  • CCR2 Targeted as an Anti Inflammatory Drug
  • CCR2 and its Receptor MCP-1 Mediated Blockage
  • CCR1
  • CCR3 Blockade
  • Migration Inhibitory Factor (MIF)
• Chemokines and Cancer
  • CXCR4 Antagonist Mozobil
  • Other CXCR4 Antagonists
  • Chemokine (C-X-C motif) Ligand 9 (MIG)
  • CXCR4
  • Stromal Cell Derived Factor SDF-1
• Chemokines and HIV Infection
  • CXCR4 and CCR5 Chemokine Receptors to Target HIV
• Current Targets in the Chemokine Market

CHAPTER 5: GROWTH AND COLONY STIMULATING FACTOR DRUGS IN DEVELOPMENT

• Epidermal Growth Factor Receptors
  • EGF Receptor Inhibitors
  • Other EGFR/HER-2 Targeting Drugs
• Vascular Endothelial Growth Factor VEGF in Angiogenesis
  • Angiogenesis Antibodies-Avastin and Lucentis
  • VEGF Antagonists Macugen, Multi-kinase Inhibitor Sutent, and Nexavar
  • VEGF Monoclonals and Inhibitors
  • VEGF Gene Therapy
• Hepatocyte Growth Factor
  • Antibodies, rHGF, Gene Therapy, and the MET Pathway
• Platelet-derived Growth Factor
  • Gleevec and other Protein Tyrosine Kinase Inhibitors
  • The Tyrosine Kinase Market
• Fibroblast Growth Factor
  • Recombinant FGF -1, Basic rFGF, r bFGF-2, FGF-20, and Monoclonals
• Transforming Growth Factor
  • TGF Binding Proteins, and Inhibitors of TGF Beta Signaling
• Insulin-like Growth Factor
  • Increlex and Iplex-rhIGF-1 and rhIGF-3
• Nerve Growth Factor
  • Monoclonals and Synthetic Neurotropin Like Agonist
• Keratinocyte Growth Factor
  • rhKGF for Oral Mucositis
• Connective Tissue Growth Factor (CTGF)
  • Monoclonal Against CTGF
• Colony Stimulating Factors (CSF)
  • Recombinant Human rhG-CSF
  • Antibodies Targeting the G -CSF Receptor and Gene Therapy
  • Non Immunological Cytokine-"Poietins" are a $10 Billion US Market
  • Erythropoietin
  • Thrombopoietin
  • Angiopoietin
• Bone Morphogenetic Proteins and Growth Differentiation Factors
  • rhBMP-2, rhBMP-7, and OPG
• Growth and Differentiation Factors GDF
  • rhGDF-5, rhBMP, Inhibition of Myostatin
• Neurotrophic Factors in Development
  • Neurturin, GDNF Gene Delivery, BDNF, CNTF
• Survival Factors as Drug Development Targets
  • Antisense to eIF-4E, Survivin
• Current Growth Factor Pipeline and Market
• The Cytokine/Growth Factor Market Revenues
• Nine Out of the Top Ten Blockbuster Drugs in 2006 were Cytokine and Growth Factor Related

CHAPTER 6: COMPANY PROFILES

• Anacor Pharmaceuticals
• Angiogenix
• Antisense Pharma
• BioMimetic
• Biopharm GmbH
• BioVex
• Cantabria
• Domantis
• ESBATech
• Nautilus Biotech
• Neovacs
• Pivotal BioSciences
• Renovo
• Scil Technology
• Uriach
• Vaccinex
• Xencor
• Yes Biotech

TABLE OF EXHIBITS

• Exhibit 2.1 Approved Immunotherapeutic Drugs Transferred to CDER
• Exhibit 2.2 Cytokine and Growth Factor Drug Revenues in 2006
• Exhibit 2.3 Worldwide Sales of FDA Approved Interferons in the US Market
• Exhibit 2.4 Mechanisms of Action for Interferon-β in MS
• Exhibit 2.5 Approved MS Interferon-β Drugs
• Exhibit 2.6 Interferon Drugs in Current Clinical Testing
• Exhibit 2.7 Combination Therapies Clinical Trials for RCC (2005)
• Exhibit 2.8 Molecular Model of Albuferon
• Exhibit 2.9 Structure of Human Interferon-ƒÁ
• Exhibit 2.10 Interleukin Drugs in Current Clinical Testing
• Exhibit 2.11 Pleiotropic Action of IL-6
• Exhibit 2.12 Antitumor Activity of Interleukin-21
• Exhibit 3.1 Status of UCB's Cimzia Anti-TNF Monoclonal
• Exhibit 3.2 Neovacs' Pipeline
• Exhibit 3.3 Ligation of TRAIL-R2 Receptors by Monoclonal Antibody
• Exhibit 3.4 Configuration of Atacicept
• Exhibit 3.5 Sales of Selected FDA-Approved TNF Inhibitors
• Exhibit 3.6 Other TNF Family Drugs in Current Clinical Testing
• Exhibit 3.7 TNF-α Drugs in Current Clinical Testing
• Exhibit 4.1 A Schematic Diagram of a Chemokine
• Exhibit 4.2 Structure of Chemokine Receptors
• Exhibit 4.3 ChemoCentryx's Chemokine Pipeline
• Exhibit 4.4 Biokine's BKT-RP3 Modeling
• Exhibit 4.5 Chemokine Drugs in Clinical Testing
• Exhibit 5.1 Structural Formula of Tarceva (erlotinib)
• Exhibit 5.2 Structural Formula of Tyrphostin (AG1478)
• Exhibit 5.3 Structural Formula of Iressa (gefitinib)
• Exhibit 5.4 Structural Formula of Sutinib Malate
• Exhibit 5.5 Structural Formula of Gleevec (imatinib mesylate)
• Exhibit 5.6 TGF-β in Fibrotic Disease
• Exhibit 5.7 Combination Immunogene Therapy
• Exhibit 5.8 Trophic and Colony Stimulating Factors in Clinical Testing
• Exhibit 5.9 Ceregene's Neurotrophic Factor Pipeline
• Exhibit 5.10 Growth Factor Drugs in Clinical Testing
• Exhibit 5.11 Forecast for 2010 Market Sector
• Exhibit 5.12 Nine out of the top ten drugs in 2005/2006 targeted Cytokines/ Growth Factors