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抗体药研究進展及市场现状分析4  

2008-07-26 15:20:08|  分类: Bio-Pharma |  标签: |举报 |字号 订阅

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Monoclonal Antibodies Report: 2008 Update

http://www.marketresearch.com/product/display.asp?productid=1804393&SID=61616071-421497808-447980567 $7600.00

Introduction

The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2013 and assessing trends by product, company, therapy area, technology and target type. It also provides an insight into the direction of mAb technology evolution and an analysis of pipeline dynamics.

Scope of this report

  • Comprehensive financial strategic analysis of the mAb market out to 2013
  • Global sales forecasts to 2013 for marketed and Phase III mAb products
  • Analysis of market trends by product, company, therapy area, technology and target type
  • Analysis of characteristics of key products and insight into direction of mAb technology evolution and pipeline dynamics

Research and analysis highlights

The overall prescription pharmaceutical market is expected to face a decline in sales over 2011 to 2012 as a result of the 'patent cliff'. The patent cliff will impact the small molecule market, in contrast, the mAb market segment will continue to record robust growth.

Over the forecast period monoclonal antibodies are predicted to enjoy double-digit growth while small molecule drugs face declining growth rates. The main barrier to sales growth for small molecules is exposure to material generic competition, which will have no effect on mAbs out to 2013.

mAbs currently command a three-fold average revenue per product premium over small molecules. Positive factors supporting this premium include a higher demand due to addressing therapy areas of high unmet need and lower competitive intensity due to accessing novel target space.

Key reasons to read this report

  • Assess the key products that will drive sales growth in the mAb market to 2013
  • Understand the challenges and barriers to entry for new players seeking to venture into the mAb market
  • Understand the nature of the generic threat across different molecule types and the insulation of mAb products from biosimilars

 

 

The commercial and therapeutic success of antibodies like Rituxan, Avastin, and Erbitux will force the industry to look into the next generation of therapeutic antibodies, preparing themselves for the second wave in the lucrative field of therapeutic antibodies. Today, there are more than 190 companies plus partners developing more than 430 antibody based oncology drugs in more than 770 developmental projects. In all targeting around 50 different cancer indications. The number of antibody targets has increased to over 170 described molecular targets in just a few years. These targets are further categorized on the CD-ROM by 37 classifications of molecular function and with pathway referals to BioCarta, KEGG and NetPath. Read more below on how the Antibody in Oncology: Drug Pipeline Update is organized.

 

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

 

 

Antibody drugs were a $24 billion business in 2007. Although most pharmaceuticals are chemically synthesized small molecules, antibodies are large and complex proteins (immunoglobulins) that act as the human body's own weapons against infections, diseases and abnormal cancer cells. Monoclonal antibodies (MAbs) mimic the body's immune system with the antibody working as the drug molecule; only MAbs are engineered artificially outside the body, in the laboratory, rather than by a person's own immune system. Furthermore, MAbs are engineered to binding to one particular antigen only. MAbs are thus important tools for medicine as extremely targeted therapies for treating patients with severe diseases - especially autoimmune conditions and cancers.

This report analyzes the activities of the leading biopharmaceutical companies with antibody-based drug products currently on the market or scheduled for introduction soon. The focus is MAb therapeutics used for treating a disease or condition (as opposed to MAbs used as a diagnostic or for research). The report details the status of drug makers' antibody pipelines; their alliances, M&As and investments to develop and commercialize new MAb drugs; and their standing in the battle for market share and bringing a new best-selling drug to patients. Technological progression in the development of antibody and protein-based human therapies is overviewed. This report is part of Fuji-Keizai's ongoing efforts to track the U.S. and global biopharmaceuticals marketplace.

*       1. Market Overview

o    Timeline of FDA approval of therapeutic MAbs (drugs now on the U.S. market)

o    MAbs in Clinical Trial (as of March 2008)

o    Market Players

o    Key Players & Business Model

o    Large Pharmas

o    Biotechnology Companies

o    Technology/Platform Companies

o    VC-funded Start-ups

o    Contract Biopharma Manufacturers

*       2. Product Trends

o    2.1 Current Products

§  Company Name/Product Name/Introduction/Target Body/2007 Sales Amount ($M)

o    2.2 Company Pipelines

§  Company Name/Project Name/Current Stage/Target Body /Important Items

*       3. Technology Trends Overview: Current to Future

o    3.1 Antibody and Immune System Overview

§  3.1.1 Antibody Structure

§  Immunoglobulin classes

§  3.1.2 Antibody Targets

§  Important targets for anti-cancer MAbs

§  Target/Drug or Drug Candidate/Status

§  3.1.3 Mechanisms of Action

§  Variety of MAbs: different technologies, structures, targets, action mechanisms

§  Brand Name/Technology/Structure/Target/Mechanism of Action

o    3.2 Antibody Generation: Current and Emerging Technologies

§  Evolution of MAb technology

§  3.2.1 Hybridoma Technology

§  Platform players:

§  3.2.2 Genetically Engineered and Humanized MAbs

§  Transgenic Animal Technologies

§  Platform players:

§  Library Technologies (phage display)

§  Platform players:

§  Optimization and Protein Engineering

§  Platform players:

§  3.2.3 Human MAb Platforms

§  MabIgX

§  HuCAL

§  3.2.4 Alternatives to plain MAbs

§  Antibody Conjugates

§  Platform players:

§  Antibody Fragments and Hybrids

§  Platform players:

§  Bifunctional MAbs

§  Platform players:

§  Recombinant polyclonal technology

§  Platform players:

§  3.2.5 Manufacturing

§  Players:

*       4. Market Analysis

o    4.1 Monoclonal Antibody Market Forecast (Total) 2006-2012

§  Key Findings

§  Late-stage MAb drugs: anticipated timeline for approval: 2009-2011

§  Growth Drivers

§  Market Impediments/Challenges

o    4.2 Breakdown by Company

§  Key Findings

o    4.3 Breakdown by Therapy Segment

§  MAb product revenues, by therapy areas: 2006-2012

§  Monoclonal antibody share of total immunology drug market (by revenues): 2008 -2012

§  Therapy Market Growth Drivers: Immunology and Cancer

§  Monoclonal antibody share of total cancer drug market (by revenues): 2012

§  Therapy areas, by market share ( %): 2007 revenues of all MAbs

o    4.4 Breakdown by Therapies in the Pipeline (2012 Market Potential)

§  Percentage of MAb drugs in pipeline, by therapy area (post-2008 potential)

§  MAb drug candidates in development, by specific disease indication

§  Growth Driver: Alzheimer's MAb pipeline

§  Findings

§  Infectious disease MAb pipeline

§  Maker/Drug Name/Stage/Therapy Market Comment

§  Osteoporosis MAb pipeline

§  Maker/Drug/Stage/Therapy Market/Comment

§  Finding

o    4.5 Breakdown by Products

§  Top 5 monoclonal antibody drugs, by sales

§  DrugMaker /Product Revenues ($ Million): 2006-2012

§  Market share (%) of top 5 MAb drugs, 2007

§  Growth Drivers of the Top 5

§  Multiple Indications as Growth Driver for Best-selling MAbs

§  Revenue for dual-purpose cancer drug Avastin: 2008-2012

§  Premium Pricing as Growth Driver and Inhibitor

§  Drug/Unit Price/Monthly or Yearly Cost

§  Finding

§  MAb oncology products, by sales

§  Drug Maker/Product Revenues ($Million): 2006-2012

§  Growth Drivers for Cancer MAb Products

§  Immunology MAb products, by sales

§  Drug Maker/Product Revenues ($Million): 2006-2012

§  Growth Drivers for Autoimmune Disease MAb Products

§  Other MAb commercialized products, by sales

§  Drug Maker /Product Revenues ($ Million): 2006-2012

§  Growth Drivers and Impediments in Other Disease Markets

o    4.6 Breakdown by Technology

*       5. M&A, Alliance Map

o    5.1 MAb and related biologics M&A activity: 2005-2008 (YTD)

§  Year/Buyer/Company Acquired /Asset Acquired/$ Value

§  Key Findings

§  Top 12 Pharmaceuticals (by 2007 sales) and MAb acquisitions or alliances

*       6. Major Company Analysis

*       6.1Abbott Laboratories

o    Profile of Monoclonal Antibody Business

o    Currently marketed MAb drugs

o    Drug Name/Target Therapy Area/Comment

o    Market Superiority

o    M&A Strategy

o    Company Pipeline Analysis

o    Technology pipeline analysis

o    Therapy area pipeline analysis

o    MAb and protein-based drugs in development

o    Target pipeline analysis

o    6.2 Amgen, Inc.

§  Same as above-mentioned research items

o    6.3 Biogen Idec, Inc.

§  Same as above-mentioned research items

o    6.4 Genentec/Roche

§  Same as above-mentioned research items

o    6.5 Johnson & Johnson/Centocor

§  Same as above-mentioned research items

o    6.6 Medimmune/Astrazeneca

§  Same as above-mentioned research items

o    6.7 Novartis Pharmaceuticals

§  Same as above-mentioned research items

o    6.8 UCB Biopharma

§  Same as above-mentioned research items

*       7. Venture Company Activity (Total 20 companies)

o    Common Research Item:

o    Location/URL

o    Profile

o    Development

*       8. Key Findings

o    Big Picture

o    Pipeline

o    Technology and Production

 

 

 

 

 

Monoclonal antibody drugs for cancer treatment: How they work

If you're considering monoclonal antibody therapy as part of your cancer treatment, learn about these drugs and carefully weigh the benefits against the potential side effects.

Monoclonal antibody drugs are a relatively new innovation in cancer treatment. The Food and Drug Administration (FDA) approved the first monoclonal antibody for cancer treatment in 1997. Today several of these drugs are available for treating certain cancers.

But because monoclonal antibody treatment is so new, the best way to use this new therapy isn't always clear. If you and your doctor are considering using a monoclonal antibody as part of your cancer treatment, find out what to expect from this therapy. Together you and your doctor can decide whether a monoclonal antibody treatment may be right for you.

What is a monoclonal antibody?

A monoclonal antibody is a laboratory-produced molecule that can be targeted to attach to specific substances on cancer cells. Your body naturally produces antibodies as part of your immune system's response to germs and other invaders. The laboratory-produced monoclonal antibodies used in cancer treatment are carefully engineered to target specific defects in your cancer cells.

How do monoclonal antibody drugs work?

When a monoclonal antibody attaches to a cancer cell, it can:

  • Make the cancer cell more visible to the immune system. The immune system attacks foreign invaders in your body, but it doesn't always recognize cancer cells as enemies. A monoclonal antibody can be directed to attach to certain parts of a cancer cell, thus marking the cancer cell and making it easier for the immune system to find.

The monoclonal antibody drug rituximab (Rituxan) attaches to a specific protein (CD20) only found on B cells, one type of white blood cell. Certain types of lymphomas arise from these same B cells. When rituximab attaches to the protein on the B cells, it makes the cells more visible to the immune system, which can then attack. Rituximab lowers the number of B cells, including your healthy B cells, but your body produces new healthy B cells to replace these. The cancerous B cells are less likely to recur.

  • Block growth signals. Chemicals called growth factors attach to receptors on the surface of normal cells and cancer cells, signaling the cells to grow. Certain cancer cells make extra copies of the growth factor receptor, thus making them grow faster than the normal cells. Monoclonal antibodies can block these receptors and prevent the growth signal from getting through.

Cetuximab (Erbitux), a monoclonal antibody approved to treat colon cancer and head and neck cancer, attaches to receptors on cancer cells that accept a certain growth signal (epidermal growth factor). Cancer cells and some healthy cells rely on this signal to tell them to divide and multiply. Doctors hope blocking the signal from reaching its target on the cancer cells may slow or stop the cancer from growing.

  • Deliver radiation to cancer cells. By combining a radioactive particle with a monoclonal antibody, doctors can deliver radiation directly to the cancer cells. This way, most of the surrounding healthy cells aren't harmed. Radiation-linked monoclonal antibodies deliver a low level of radiation over a longer period of time, which researchers believe is as effective as the more conventional high-dose external beam radiation.

Ibritumomab (Zevalin), approved for non-Hodgkin's lymphoma, combines a monoclonal antibody with two radioactive particles. The ibritumomab monoclonal antibody attaches to receptors on cancerous blood cells and delivers the radiation.

  • Slip powerful drugs into cancer cells. Powerful anti-cancer drugs or toxins can be attached to monoclonal antibodies. The drugs remain inactive until they're inside the target cells, lowering the chance of harming other cells.

Gemtuzumab (Mylotarg), approved for treating a certain type of acute myelogenous leukemia, is a monoclonal antibody attached to a potent anti-cancer drug made from a bacterium. The monoclonal antibody in gemtuzumab attaches to specific receptors on leukemic cells. Then the anti-cancer drug enters the cancer cell and is activated, causing the cancer cell to die.

A number of monoclonal antibody drugs are available to treat various types of cancer. Clinical trials are studying monoclonal antibody drugs in treating nearly every type of cancer.

How are monoclonal antibody drugs used in cancer treatment?

Monoclonal antibody drugs were initially used to treat advanced cancers that hadn't responded to chemotherapy or cancers that had returned despite treatment. However, because these treatments have proved to be effective, certain monoclonal antibody treatments are being used earlier in the course of the disease. For instance, rituximab can be used as an initial treatment in some types of non-Hodgkin's lymphoma, and trastuzumab (Herceptin) is used in the treatment of some forms of early breast cancer.

Many of the monoclonal antibody therapies are still considered experimental. For this reason, these treatments are usually reserved for advanced cancers that aren't responding to standard, proven treatments.

FDA-approved monoclonal antibodies for cancer treatment

Name of drug

Type of cancer used to treat

Alemtuzumab (Campath)

Chronic lymphocytic leukemia

Bevacizumab (Avastin)

Colon cancer
Lung cancer

Cetuximab (Erbitux)

Colon cancer
Head and neck cancer

Gemtuzumab (Mylotarg)

Acute myelogenous leukemia

Ibritumomab (Zevalin)

Non-Hodgkin's lymphoma

Panitumumab (Vectibix)

Colon cancer

Rituximab (Rituxan)

Non-Hodgkin's lymphoma

Tositumomab (Bexxar)

Non-Hodgkin's lymphoma

Trastuzumab (Herceptin)

Breast cancer

Source: Food and Drug Administration, Center for Drug Evaluation and Research

Monoclonal antibodies are administered through a vein (intravenously). How often you undergo monoclonal antibody treatment depends on your cancer and what drug you're receiving. Some monoclonal antibody drugs may be used in combination with other treatments, such as chemotherapy. Others are administered alone.

What types of side effects do monoclonal antibody drugs cause?

Monoclonal antibody treatment for cancer may cause side effects, some of which, though rare, can be very serious. Talk to your doctor about what side effects are associated with the particular drug you're receiving.

In general, the more common side effects caused by monoclonal antibody drugs include:

  • Allergic reactions, such as hives or itching
  • Flu-like symptoms, including chills, fatigue, fever and muscle aches and pains
  • Low blood cell counts, which may lead to bleeding, fatigue and infection
  • Nausea
  • Diarrhea
  • Skin rashes

Rare, but more serious side effects of monoclonal antibody therapy may include:

  • Infusion reactions. Severe allergy-like reactions can occur and, in a very small number of instances, lead to death. You may receive medicine to block an allergic reaction before you begin monoclonal antibody treatment. Infusion reactions usually occur while treatment is being administered or soon after, so your health care team will watch you closely for a reaction.
  • Dangerously low blood cell counts. Low levels of red blood cells, white blood cells and platelets may lead to serious complications.
  • Heart problems. Certain monoclonal antibodies may cause heart problems, including heart failure and a small risk of heart attack.
  • Skin problems. Sores and rashes on your skin can lead to serious infections in some cases. Serious sores can also occur on the skin that lines your cheeks and gums (mucosa).
  • Bleeding. Some of the monoclonal antibody drugs are designed to stop cancer from forming new blood vessels. There have been reports that these medications can cause bleeding.

How are monoclonal antibody drugs being studied?

Cancer researchers are continuing to study already-approved monoclonal antibody drugs to determine how best to use them to treat cancer. Clinical trials comparing monoclonal antibodies with other standard treatments may help doctors decide if monoclonal antibody therapy should be used sooner, rather than after other treatments have failed. These studies can also determine whether monoclonal antibodies might work best when combined with other treatments.

Cancer researchers are also working to develop new monoclonal antibodies. As they come to better understand the particular cellular changes associated with each type of cancer, researchers are discovering new targets for monoclonal antibodies.

Research and Markets (http://www.researchandmarkets.com/reports/c48797) has announced the addition of Monoclonal Antibodies 2007: Competitive Landscape & Pipeline Insight to their offering.

In 2005, the antibodies market was valued at an estimated US$14 billion, accounting for over 24 percent of the total protein therapeutics market. This share increased substantially since 2001, when it barely surpassed 13 percent. Monoclonal antibody (MAbs) therapies have been posting the fastest growth within the protein therapeutics market. According to Arrowhead Publishers' report Monoclonal Antibody Therapies 2007: Competitive Landscape and Pipeline Insight the ...

THE FIRST ROUND of monoclonal antibody drugs to hit the market is offering early insight into the vast therapeutic and commercial potential of the market. Several key players, each applying a unique technology or mix of technologies, have emerged to exploit the full potential of monoclonal antibodies. Now, with the technology maturing and a broad array of promising drugs filling the pipeline, companies are shifting from a technology development model to become product firms.

The Food and Drug Administration (FDA) has approved a monoclonal antibody for use in acute rejection episodes following kidney transplants. Though monoclonal antibodies are already used on blood and tissue for diagnostic purposes, last week's announcement marked the first time such an antibody has been okayed for use in humans

 

 

2004 nian

The discovery of hybridoma technology by Milstein and Kohler in 1975 allowed researchers to isolate specifically defined monoclonal antibodies (MAB). Although their potential in clinical use was immediately felt, it took more than a decade before a therapeutic monoclonal antibody became available in clinics. One of the major limitations was regarding the origin of MAB from mouse and administering to human beings. It acted as a foreign antibody, stimulating an immune reaction, and leading to adversities in therapeutics. Advancements in molecular biology later made it possible to develop human MAB in a way that is acceptable to the human immune systems.

Table 1. Therapeutic antibodies for treatment of cancer

Product

Therapeutic application

Manufacturer/ Inventor

Campath

B-cell lympholytic luekemia

Mellinium pharma Inc.

Gemtuzumab

Acute myeloid leukemia

Cell tech.

Herceptin

Matastatic breast cancer

Genetech.

Panorex

Colorectal cancer

Centocor  GSK

Rituximab

Non Hodgkin cancer

Genetech

Bexxar

Non Hodgkin lymphoma

Coraxia GSK

Edrecolomab

Colorectal cancer

Glaxo-wellcome

Alemtuzumab

Bull chronic lympholytic leukemia

ILEX Pharmaceuticals

Mylotrag

Acute myelogeneuos leukemia

Wyeth-Ayerst Research

IMC-C225

Head and Neck cancer

Imclone systems

Smartin 195

Acute myeloid leukemia

 

Mitomomab

Melanoma and Small cell lung cancer

Imclone systems


Generally, MAB is being used as invaluable reagents in diagnostics. In fact, they have played a major role in deciphering the functions of various bio-molecules in cryptic biosynthetic pathways. These have also become the reagents of choice for identification and characterization of tumor specific antigens and have become a valuable tool in the classification of cancer. Previously, as they were derived from murine sources, they had limited applications in therapeutic reagents. The repeated application to human subjects challenged the human immune system, leading to severe immune reactions. In order to circumvent the immunogenicity of murine antibodies, the development of humanized MAB, initialized with the strategy described below: -

* Immortalizing the human bursa derived cells.
* Chimeric antibodies comprising human and mice, in which a constant part from human antibodies are coined to a variable part of light and heavy chains from mouse in which 70% of the antibody comprising of human was retained.
* Humanized antibodies prepare by getting complementary determining regions of murine antibodies on to a human antibody framework, which has 90% resemblance to humans.
* Manipulation of CPR region towards the target antigen by linking the variable light and heavy chain segments to a single chain variable fragment.
* Use a transgenic map like HUMAB resulting in hybridomas producing 100X human MAB.
* Use trans-chromosomic mice having a part of human chromosome that contained complete germ-line clusters of heavy and light chain.

Table 2. Therapeutic antibodies approved for clinical practice.

Product

Therapeuticapplication

Manufacturer

OrthocloneOKT3

Kidneytransplant rejection

Orthobiotech

Reopro

Preventionof blood clot

Centocor

Remicade

Rhuetoidarthritis

Centocor

Zenapax

Preventionof acute kidney transplant

Reopro

Abciximab

Inhibitionof platelet function

Reopro


Traditionally, MAB have been produced as native molecules in murine hybridoma lines. However, there has been considerable interest in development of recombinant DNA expression of MAB. This would allow the production of humanized antibodies as well as spectrum of antibody derivatives and fusion proteins in a host species of choice. More recently, the production of antibodies in the milk (or other body fluids of transgenic animals and chicken eggs) has emerged as a promising alternative for fermentation based production systems. The main advantages of transgenic animals are potential high yields from renewable sources. However, the potential for scale up is limited and there are concerns that animals could harbor human pathogens such as viruses or prions, or that product could be contaminated with undesirable DNA sequence.

Table 3. Status of antibodies in clinical trails.

Product

Application

Manufacturer/inventor

Status

Avicidin

Marker for colorectal cancer

NoeRxMonsanato

Withdrawn from phase II clinical trails

CaroRx

Acts against Streptococcus advari mutants which causes tooth decay

Majk et.al.in 1999. Larrik, 2001.

Phase II clinical trails successful.

T84.66

Markers for epithelial cancers

Porrinet.al, 2000

Tested for tumor imaging and anti-tumor therapy

AntiHSV

Prevention of vaginal herpes simplex virus

Zeitilinet.al, 1998

Preventionin HSV-2 transmission in mouse

38C13

Potential for non-Hodgkin's lymphoma.

McCormicket. al , 1999

Prevents experimental induced lymphomas in mice

PIPP

Diagnosis and therapy of tumor producing HCG hormone in leidig's cells, pregnancy detection kit and contraception

Kathmicet.al, 2002

Developmental stage.


Plants have emerged recently as a convenient, safe and economical alternative main-stream expression systems for recombinant antibody production, which are based on large scale culture of microbes or animal cells. Several plant-derived antibodies have reached advanced stages of development and out of these, two have progressed to phase II clinical trial

 

 

 

 

 

ISIS Press Release 10/04/06

Warnings on FDA Approved Monoclonal Antibody Drugs

Prof. Joe Cummins

This is a compilation of safety information on monoclonal antibody drugs already approved by the US FDA (Food and Drug Administration), most of them posted on the FDA website. The URLs are included at the time of compilation (23 March 2006).

  1. Orthoclone OKT 3 mouse monoclonal antibody, Ortho Biotech, Transplant anti-rejection

Safety information:  Anaphylactic or anaphylactoid reactions may occur following administration of any dose or course of ORTHOCLONE OKT3. In addition, serious, occasionally life-threatening or lethal, systemic, cardiovascular, and central nervous system reactions have been reported following administration of ORTHOCLONE OKT3. These have included: pulmonary edema, especially in patients with volume overload; shock, cardiovascular collapse, cardiac or respiratory arrest, seizures, coma, cerebral edema, cerebral herniation, blindness and paralysis. http://www.orthobiotech.com/orthoclone.html

  1. ReoPro  humanized mouse  monoclonal antibody Centocor, prevents blood clotting

Side effects: Acid or sour stomach; belching; burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings; changes in vision; delusions; dementia; fear; heartburn; indigestion or stomach discomfort, upset or pain; mood or mental changes; nausea; nervousness; vomiting. http://www.drugs.com/cons/ReoPro.html

  1. Rituxan (Rituximab) humanized mouse monoclonal antibody Genetech, treatment of Non-Hodgkins lymphoma

Warning: Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. These fatal reactions followed an infusion reaction complex which included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrilation orcardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. http://www.fda.gov/medwatch/SAFETY/2005/Jan_PI/Rituxan_PI.pdf

  1. Zenapax (daclizumab) humanized mouse monoclonal antibody, Hoffman-La Roche,  transplant immune suppression

Warning: Severe, acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to ZENAPAX and following re-exposure. These reactions may include hypotension, bronchospasms, wheezing, laryngeal edema, pulmonary edema, cyanosis, hypoxia, respiratory arrest, cardiac arrhythmia, cardiac arrest, peripheral edema, loss of consciousness, fever, rash, urticaria, diaphoresis, pruritus, and/or injection site reactions. http://www.fda.gov/medwatch/SAFETY/2003/zenapax.htm

  1. Simulect humanized mouse monoclonal antibody, Novartis transplant ant-rejection

Warning: severe acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to Simulect® and/or following re-exposure after several months. These reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing. If a severe hypersensitivity reaction occurs, therapy with Simulect® should be permanently discontinued. Medications for the treatment of severe hypersensitivity reactions including anaphylaxis should be available for immediate use. Patients previously administered Simulect® should only be re-exposed to a subsequent course of therapy with extreme caution. http://www.fda.gov/medwatch/safety/2000/simule.htm

  1. Synagis  humanized mouse monoclonal antibody, Medimmune,  anti-respiratory syncytial virus 

Warning: Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to Synagis (palivizumab) [see Adverse Reactions, Post-Marketing Experience]. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to palivizumab. http://www.fda.gov/medwatch/SAFETY/2002/Synagis_PI.pdf

  1. Remicade,  humanized mouse monoclonal antibody, Centocor anti-arthritis

Warning; tuberculosis infection some fatal http://www.fda.gov/medwatch/safety/2005/Sep_PI/Remicade_PI.pdf

  1. Herceptin (Trastuzumab) humanized mouse monoclonal antibody, Genetech cancer therapy

Warning: CARDIOMYOPATHY: HERCEPTIN administration can result in the development of ventricular dysfunction and congestive heart failure. http://www.accessdata.fda.gov/scripts/cder/onctools/labels.cfm?GN=Trastuzumab

  1. Mylotarg humanized mouse monoclonal antibody,Wyeth, cancer therapy

Warning: Mylotarg administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal http://www.fda.gov/medwatch/SAFETY/2004/apr_PI/Mylotarg_PI.pdf

  1. Campath-1H (Alemtuzumab) humanized mouse monoclonal antibody, Genzym leukemia cancer treatment 

Warning: Campath may lower the ability of the bone marrow to make blood cells. Some of these effects can be severe and lead to death. Three patients in a clinical study of the drug Campath for the treatment of Multiple Sclerosis (MS) developed severe idiopathic thrombocytopenic purpura (ITP). http://www.fda.gov/cder/drug/InfoSheets/patient/alemtuzumabPIS.pdf

  1. Zevalin Mouse monoclonal antibody, Biogen Idec cancer therapy (Yttrium  radio therapy associated)

Warning: Deaths have occurred within 24 hours of Rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. http://www.accessdata.fda.gov/scripts/cder/onctools/labels.cfm?GN=Ibritumomab%20Tiuxetan

  1. Humira Human monoclonal antibody, Abott  arthritis treatment

Warning: TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS RECEIVING HUMIRA. SOME OF THESE INFECTIONS HAVE  BEEN FATAL  http://www.fda.gov/medwatch/safety/2005/Oct_PI/Humira_PI.pdf

  1. Xolair humanized mouse monoclonal antibody, Genetech treatment of allergic asthma

 Warning: more patients treated with Xolair developed a new or recurrent cancer compared to control patients. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=153

  1. Bexxar (Tositumomab and Iodine I 131) mouse monoclonal antibody Corixa company, cancer therapy 

Warning: Hypersensitivity reactions, including anaphylaxis.  http://www.fda.gov/cder/foi/label/2003/tosicor062703LB.pdf

  1. Raptiva humanized mouse monoclonal antibody, Genetech, treatment of psoriasis

Warning: Hemolytic anemia; serious infections has been updated to include rare postmarketing reports of necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (e.g. cellulitis,pneumonia) despite antimicrobial treatment. http://www.fda.gov/medwatch/safety/2005/raptiva_deardoc_071205.pdf

  1. Erbitux humanized mouse monoclonal antibody, Imclone systems, cancer therapy

Warning: Severe infusion reactions occurred with the administration of ERBITUX in approximately 3% of patients, rarely with fatal outcome (<1 in 1000). Severe infusion reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension. http://www.fda.gov/medwatch/safety/2005/Sep_PI/Erbitux_PI.pdf

  1. Avastin humanized mouse monoclonal antibody Genetech, cancer therapy 

Warning: AVASTIN administration can result in the development of gastrointestinal perforation and wound dehiscence, in some instances resulting in fatality. Gastrointestinal perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with AVASTIN. Serious, and in some cases fatal, hemoptysis has occurred in patients with non–small cell lung cancer treated with chemotherapy and AVASTIN. http://www.fda.gov/cder/foi/label/2004/125085lbl.pdf

  1. Tsabri humanized mouse monoclonal antibody, Biogen Idec, treatment of multiple sclerosis (MS)

Suspended Marketing of Tysabri (natalizumab) 2005:  FDA is issuing this public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA has received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed, fatal case and one additional case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis (MS). Both patients were enrolled in a long-term clinical trial and had been taking Tysabri for more than two years. http://www.fda.gov/cder/drug/advisory/natalizumab.htm

 

 

Monoclonal Antibody Therapeutics - Current Market Dynamics & Future Outlook


The global market for Monoclonal Antibody (Mab) Therapeutics reached a total of $11.2 billion in 2004. The market has been growing at an impressive compound average annual growth rate of 42% over the previous five years.

The key advantage of Mab Therapeutics is their high levels of specificity for the relevant disease targets. This pinpoint specificity also serves to prevent harm to healthy cells and, hence, typically results in fewer adverse effects compared to other medicines.

Many of the leading pharmaceutical companies have entered the MAb sector, attracted by quicker and less costly development, higher success rates, premium pricing, and a potentially reduced threat from generics.

The outlook for monoclonal antibody therapeutics is healthy. The ongoing success of existing products, combined with a bulging pipeline of new products awaiting approval and limited generic erosion, point towards robust growth in this segment.

Industry participants forecast of the market vary widely, however, a consensus is emerging that the market should reach US$34 billion by the end of the decade.

Monoclonal Antibody Therapeutics - Current Market Dynamics and Future Outlook report reviews the current status of the market for monoclonal antibody therapeutics, highlights the differences between regional markets, profiles leading products and their marketing companies and discusses the different windows of opportunities opening in this market.

The report provides figures of market size, growth rates and historical evolution of the global, North American and European Mab Therapeutics markets. It also provides sales and growth rate figures for some of the leading monoclonal antibody therapeutics including: Remicade, Rituxan / MabThera, Herceptin, Synagis, Humera, Avastin, Xolair and ReoPro (Abciximab).

The report also discusses the monoclonal antibody therapeutics market outlook, growth potential, attractive areas of growth, technological innovations, products in development and consensus forecasts to the year 2010.

Written with the senior executive needs in mind, Monoclonal Antibody Therapeutics - Current Market Dynamics & Future Outlook, is a must read for pharmaceutical and medical biotech professionals interested in high growth area therapeutics.

 

In 2005, the antibodies market was valued at an estimated US$14 billion, accounting for over 24 percent of the total protein therapeutics market. This share increased substantially since 2001, when it barely surpassed 13 percent. Monoclonal antibody (MAbs) therapies have been posting the fastest growth within the protein therapeutics market. According to Arrowhead Publishers’ report Monoclonal Antibody Therapies 2007: Competitive Landscape and Pipeline Insight the value of this market is set to reach more than $16 billion in 2006This growth will continue in the coming years, boosted by a number of new MAbs on the market, new indications for successful medications, and their ability to treat conditions and diseases for which there is great unmet need.

Monoclonal Antibody Therapies 2007 provides an analytically-based overview of the growing market for therapeutic monoclonal antibodies, which represent the largest segment of protein-based therapeutics. An increasing number of biotech companies are investing in the MAbs field, mostly in collaboration with major pharmaceutical companies, to take advantage of this dynamic and growing field.

This report assesses the overall monoclonal antibody market, as part of the wider protein therapeutics industry. Factors influencing their historical and future performance - including manufacturing problems and the impact of future generic competition - are assessed to provide a balanced overview of the market and key products by major therapeutic categories. Finally, the report forecasts likely revenue performance of the most successful products in the next five years, identifying key areas of growth.

According to the market research report "Global Protein Therapeutics Market Analysis", the Protein Therapeutic Market was valued in excess of US$ 57 Billion in 2006 and according to projections, it would grow at a CAGR 12.83% till 2010 The market is presently dominated by Monoclonal Antibodies and with double-digit growth projected for future, the segment is expected to bolster its dominant position. Insulin, Interferon Beta, G-CSF and coagulation factors are also exhibiting double-digit growth rates.


 
One of the biggest opportunity areas in the Protein Therapeutics Market will be in the field of Biogenerics, which is expected to create a multi-billion dollar market in future.

 

Monoclonal antibody therapies have been posting the fastest growth within the protein therapeutics market easily outstripping the growth rate of 0.6% in the more traditional, small molecules market. With key products forecast to record peak sales growth and the launch of new products, this rapid expansion is set to continue. In addition to occupying a sector of the market that is insulated from generic competition, mAbs have the advantage of primarily addressing high unmet need therapy areas such as oncology and AIID. Hundreds of monoclonal antibodies are presently undergoing various stages of clinical development. Many in the industry are utilizing ex vivo libraries and development of transgenic mice which generate antibodies with a human protein sequence instead of a mouse protein sequence, thus allowing for the development of mAbs with higher human composition. Alliances between pharmaceutical and biotech companies are a key driver of the current mAb market. With big pharma backing smaller biotech companies in their research and clinical programs, and thus funding vital manufacturing facilities, there is little reason why the mAb market will not continue to flourish. Delivered by a panel of expert speakers Visiongain’s 4th Annual Monoclonal Antibodies in Therapeutics, will provide the ideal forum for leading companies, and those with emerging products or technologies to collaborate and exchange ideas. This two- day programme will examine strategies employed by biotechnology companies and pharmaceutical firms to develop and market products in this highly exciting market sector, and discuss the advantages and limitations of antibody-based products, patent issues and applicability.

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