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Reportlinker Adds Immunotherapies and Vaccines for Nontraditional Indications

Monday 26th of October 2009 14:15

NEW YORK, Oct. 26 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue.

Reportlinker Adds Immunotherapies and Vaccines for Nontraditional Indications

http://www.reportlinker.com/p0155768/Reportlinker-Adds-Immunotherapies-and-Vaccines-for-Nontraditional-Indications.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire

Executive Summary

The earliest immunotherapies were vaccines that stimulate the immune system's response against infectious agents, providing protection against those diseases. Vaccines and immune globulin preparations (passive immunotherapies) have been used for many years to enhance the immune system's response against infectious diseases. More recently, a number of monoclonal antibodies have been commercialized for treatment of cancer, and a number of active immunotherapies and vaccines that stimulate the immune response against cancer are being developed. These applications of immunotherapy focus on the benefits of the immune system when it is working correctly, and the potential beneficial therapies that may be developed by enhancing the immune response.

In contrast, sometimes a person's immune system goes awry, either attacking the person's own body, or overreacting or producing exaggerated response to a foreign substance that is normally harmless to most people. In these situations, therapies are needed to suppress or modulate the unwanted immune response. Therapies that suppress or modulate the immune response are currently available. More are being developed for treatment of autoimmune diseases, treatment of allergies, or prevention of transplant rejection.

These are the most well-known applications of immunotherapies and vaccines that enhance the immune system. However, many other applications are possible. Research and development of immunotherapies for these other indications has been progressing for many years, even though this effort has not received the public attention that the work on infectious disease and cancer immunotherapies and vaccines has seen. This report discusses many of these other applications of monoclonal antibodies, therapies derived from antibodies, vaccines, and therapies that modulate the immune response for treatment of a wide range of disorders and diseases.

Some of the emerging therapies discussed in this report have been developed for treatment of diseases that are caused by the immune system including inflammatory diseases (diseases resulting from the immune response) and also disorders resulting from changes in the complement system. However, there are also other disorders included in this report that are not immune-mediated diseases or the result of the immune response. For these disorders, antibodies are being used as tools to block targeted proteins that have a role in the disease process. These antibodies may be delivered passively, or they may be generated by the patient's own body in response to a vaccine.

Chapter 2 discusses the progress in developing immunotherapies and vaccines for treatment of Alzheimer's disease. Several immunotherapies that target beta amyloid are in development, including both monoclonal antibodies and vaccines. The most advanced is bapineuzumab, which is in Phase III development by Wyeth and Elan. In this chapter, the pathophysiology, epidemiology, and current therapy of Alzheimer's disease are discussed. This is followed by a section that discusses why companies are developing antibodies and vaccines for treatment of Alzheimer's disease. The next section of Chapter 2 discusses many of the emerging immunotherapies for Alzheimer's disease that have reached clinical development. Even more emerging immunotherapies for this indication are included in a table that accompanies this section. The final section of this chapter discusses business considerations for companies that are developing immunotherapies for treatment of Alzheimer's disease.

Similar sections are included in each of the subsequent chapters about different disease indications. Chapter 3 discusses immunotherapies that are being developed for treatment of two different addictions: nicotine and cocaine. With these immunotherapies, antibodies are either passively administered or are produced by the patient's body in response to a vaccine. The antibodies then bind to either nicotine or cocaine, creating a large molecule that cannot be transported across the bloodbrain barrier. Immunotherapies are being developed for a wide range of different neurological indications, and several of these additional indications are discussed in Chapter 4 and/or are included in a table of therapies in development that accompanies Chapter 4. These additional neurological conditions include pain, multifocal motor neuropathy, treatment of pain in dental patients undergoing third-molar extraction, treatment of ankylosing spondylitis, rheumatoid arthritis, chronic low back pain, endometriosis, the pain associated with cancer that has metastasized to the bone, blocking a protein that inhibits axonal regeneration (for treatment of stroke), and Parkinson's disease.

Immunotherapies (including antibodies and vaccines) are also being developed for treatment of different cardiovascular disorders. These are discussed in Chapter 5. The targeted cardiovascular disorders include angina, atherosclerosis, dyslipidemia, hypertension, venous thromboembolism, and digoxin toxicity. Chapter 6 discusses the development and use of immunotherapies for hematological disorders including idiopathic (immune) thrombocytopenic purpura (ITP), paroxysmal nocturnal hemoglobinuria (PNH), and Rh incompatibility and hemolytic disease of the newborn (HDN).

Antibodies can also be used for treatment of ophthalmic diseases. As discussed in Chapter 7, Lucentis (ranibizumab) is an antibody fragment that binds to and inhibits VEGF. It is FDA approved for treatment of neovascular (wet) age-related macular degeneration. It is also in late-stage clinical development for additional ophthalmic indications. A human monoclonal antibody against VEGF, Genentech's/Roche's Avastin (bevacizumab), is FDA approved for treatment of colorectal cancer, non-small cell lung cancer, breast cancer, and glioblastoma. While Avastin is not approved for treatment of wet AMD, it is also used for this indication. Other examples of ophthalmic diseases for which antibodies are being developed include diabetic retinopathy and diabetic macular edema, retinal vein occlusion, and uveitis. Chapter 8 discusses the development of antibodies for treatment of osteoporosis and other bone metabolism disorders. The most advanced of these is Amgen's denosumab, which is a human monoclonal antibody that targets the receptor activator of nuclear factor kappa beta ligand (RANKL). Denosumab has been submitted to the FDA. Ablynx (Belgium) is developing nanobodies that target RANKL. These are in preclinical development. In addition, Amgen (with UCB Pharma) is also developing Sclerostin Ab, a humanized antibody that targets the protein sclerostin.

In addition, multiple monoclonal antibodies are being developed for treatment of type 2 diabetes. Three companies are developing antibodies that target IL-1 beta, a pro-inflammatory cytokine that stimulates the immune response. The second molecule being targeted by a monoclonal antibody in development for type 2 diabetes is the glucagon receptor. These are discussed in Chapter 9. In addition to all of these activities in neurology, cardiovascular disease, hematology, ophthalmology, osteoporosis, and type 2 diabetes, many additional antibodies, antibody-based drugs, and other immunotherapies/anti-inflammatory drugs are being developed to treat a wide range of indications. Several examples of those that have reached clinical development are discussed in Chapter 10, and even more are included in the table that accompanies Chapter 10. This report also includes seven interviews with experts in the application of antibodies, antibody-derived therapies, and vaccines to the treatment of various diseases included in this study. These experts discuss the progress, challenges, and hurdles faced by researchers and companies working in this field.

Table of Contents

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

Baxter

Novartis and Cytos Biotechnology

Eli Lilly

Genentech and AC Immune

GlaxoSmithKline

Merck & Co.

Octapharma

Pfizer

Roche and MorphoSys

Wyeth and Elan

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

Nicotine Addiction (Smoking Cessation)

Celtic Pharma

Nabi Biopharmaceuticals

Novartis and Cytos Biotechnology

3.4. Business Considerations: Immunotherapies for Cocaine Addiction or Smoking Cessation

Chapter 4 - OTHER NEUROLOGY INDICATIONS FOR MONOCLONAL ANTIBODIES AND IMMUNOTHERAPIES

4.1. Pathophysiology, Epidemiology, and Current Treatments

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 Treatments

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 BI-204 (anti-oxLDL)

GlaxoSmithKline's Digibind

Roche's and Genmab's R1512

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

Alexion Pharmaceuticals' Soliris (eculizumab)

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 Disorders?

8.3. Companies Developing Antibodies for Osteoporosis and Other Bone Metabolism Disorders

Ablynx' ALX-0141

Amgen's 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

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

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

Tables and Figures

FDA-Approved Drugs for Treatment of Alzheimer's Disease

Selected Companies Developing Immunotherapies (Monoclonal Antibodies or Vaccines) for Treatment of Alzheimer's Disease

FDA-Approved Drugs for Use as an Aid in Smoking Cessation

Selected Companies Developing Vaccines for Treatment of Cocaine Addiction or Nicotine Addiction (Smoking Cessation)

Selected Non-Opioid Analgesics

Selected Opioid Analgesics

Selected Companies Developing and/or Marketing Immunotherapies (Antibodies, Antibody-Derived Agents, or Vaccines) for Other Neurology Applications

Selected Heart/Cardiovascular Drugs Including Lipid-Lowering Drugs and Drugs for Treatment of Hypertension

Selected Companies Developing and/or Marketing Immunotherapies (Antibodies, Antibody-Derived Agents, or Vaccines) for Cardiovascular Diseases

FDA-Approved Immune Globulin Intravenous (IGIV) Preparations and Their Indications

FDA-Approved Rho(D) Immune Globulin and Immune Globulin Intravenous Preparations

Current Non-Immune Globulin Therapies for Selected Hematology Indications

Emerging Immunotherapies for Treatment of Hematology/Blood Disorders

Current Pharmacological Therapies for Wet Age-Related Macular Degeneration

Emerging Antibody-Based Therapies for Ophthalmic Diseases

FDA-Approved Drugs for Prevention and Treatment of Osteoporosis

Emerging Antibodies and Antibody-Derived Therapies for Osteoporosis and Other Bone Metabolism Disorders

FDA-Approved Drugs for Treatment of Type 2 Diabetes

Emerging Monoclonal Antibodies for Treatment of Type 2 Diabetes

Emerging Antibodies, Antibody-Based Drugs, and Anti-inflammatory Drugs for Selected Other Indications

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Reportlinker Adds Immunotherapies and Vaccines for Nontraditional Indications

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