Angiongenesis Inhibitors and Stimulators: Market Research Report

I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study

1. ANGIOGENESIS INHIBITORS

2. ANGIOGENESIS STIMULATORS

II. EXECUTIVE SUMMARY

1.MARKET OUTLOOK

Angiogenesis: In the Spotlight
Angiogenesis: A Preview

2.MARKET OVERVIEW

Angiogenesis Makes Inroads: A Retrospect
Angiogenesis: Ushering-In a New Era
Angiogenesis: Fact File
Milestones in Research Achieved Over the Years
Anti-Angiogenic Drugs Market – An Overview
Angiogenic Inhibitors Market to Surge
The Long Journey for Anti-Angiogenesis Therapies
Approved Anti-Angiogenesis Drugs in the Market
Select FDA-Approved Anti-Angiogenic Drugs/ Therapeutics In Oncology By Type Monoclonal Antibody Therapies
Small Molecule Tyrosine Kinase Inhibitors
Inhibitors of mTOR
Other Anti-Angiogenic Agents
Leading Drugs in the Market
Avastin Leads the Fray


Overview of Select Leading Drugs
Avastin
Survival Benefit Conferred by Avastin
Mechanism of Action
General Mode of Delivery
Side Effects Elicited on Administering Avastin
ERBITUX™ (Cetuximab)
Regulatory Approvals
Erbitux in Head and Neck Cancer
Glivec/Gleevec (imatinib mesylate)
Herceptin (Tractuzumab)
Sutent (Sunitinib)
Other Regulatory Approvals
Sunitinib in Various Indications
Sunitinib in Renal Cell Carcinoma (RCC)
Sutent in Gastrointestinal Stromal Tumors (GIST)
Cost Related Issues
Tarceva (Erlotinib)
Other Regulatory Approvals
Thalomid® (Thalidomide)


Cilengitide
Imiquimod
Angiogenesis Inhibitors – Pipeline Status
Select Anti-Angiogenesis Drugs in Phase III Development
Select Anti-Angiogenesis Drugs in Phase II Development
Select Anti-Angiogenesis Drugs in Phase I Development
Select Approved Indications of Anti-VEGF/VEGFR Drugs
Novel Targets for Anti-Angiogenic Activity
Select Approved HER Receptor-Targeting Drugs
Select Approved m-TOR Inhibitors
Integrins
Select Integrin Targeting Drugs under Development
Angiogenic Inhibitors – By Disease Application
Cancer
Various Types of Cancers Targeted by Angiogenesis Inhibitors in Phase III Clinical Development
Diabetic Retinopathy
Female Reproductive Cycle
Psoriasis
Inflammatory Diseases


Angiogenesis Inhibitors in Eye Related Diseases
Age-Related Macular Degeneration
Wet AMD
Dry AMD
Select Anti-Angiogenic Drugs Approved by FDA for Treatment of Eye Diseases
Angiogenesis Inhibitors in Dermatology
Select Drugs/Therapeutics with Angiogenic Mode of Action Approved by FDA for Dermatology

3.MARKET TRENDS

Cancer – The Key Target Indication for Research in Anti-Angiogeneis Drugs
Avastin Continues to Record Robust Growth
New Markets Offer Higher Potential for Herceptin
Increased Use Drives Tarceva’s Growth in Developed Markets
Angiogenesis Inhibitors Continue to Dominate RCC Drug Market
Votrient to Lead Renal Cell Carcinoma (RCC) Drug Market


Clinical Benefits of Votrient Over Sutent
US FDA Revokes Avastin Approval for Breast Cancer

4.ANGIOGENESIS REPERTOIRE

An In-depth Insight into Angiogenesis
Angiogenesis: At a Glance
Requisites for Angiogenesis
Endogenous Regulators of Angiogenesis
Angiogenic Process: Sequence of Events
Angiogenesis Process in Children
Angiogenesis Process in Adults
The Process of Angiogenesis in Thyroid Gland

5.ANGIOGENESIS INHIBITORS

Angiogenic Inhibitors: Basic Framework
Natural Inhibitors
Thrombospondin
Interferon
Cryptic Inhibitors
Other Natural Inhibitors
Natural Sources for Anti-Angiogenic Action
Potential Anti-Angiogenic Drugs of Natural Origin
Angiogenic Inhibitors: On the Verge of Attaining Superior Clinical Efficacy
Endogenous vs Synthetic Agents
Angiogenesis Inhibitors: Classification Based on Source of Origin
Anti-Angiogenic Molecules: Classification Based on Mode of Action
Broad Overview of Anti-Angiogenic Therapies
Pre-Requisites for Any Drug to be an Angiogenic Inhibitor
Specific Therapeutic Strategies of Anti- Angiogenesis Agents
Inhibiting Angiogenesis In Vivo
Antiangiogenic Tumor Therapy
Antivascular Therapy: Adding a New Dimension
MMPs – Exhibiting Dual Role
Angiogenesis Inhibitors Vs Standard Chemotherapy
Comparison Between Cytostatic Antiangiogenesis and Cytotoxic Chemotherapy
Proteoglycan Mixture: Therapeutic Powerhouse
Features of VascuStatin
Angiogenesis Inhibition Versus Cytotoxic Therapy
Relationship Between Copper and Angiogenesis
Anti-Angiogenesis Action of Pencillamine
Outline of Steps Involved in Drug Discovery for Angiogenesis
Drug Delivery: Their Influence on Therapeutics

6.PROMOTERS OF ANGIOGENESIS/ ANGIOGENESIS STIMULATORS

Angiogenesis Stimulators
Growth Factors
Angiogenic Stimulators in the Market
Stimulators Exhibiting Profound Influence on Angiogenesis
Vascular Endothelial Growth Factor (VEGF)
VEGF and Their Influence on Diabetes and Diabetic Retinopathy
Fibroblast Growth Factors (FGFs)
Basic Fibroblast Growth Factor (bFGF)
Placental Growth Factor (PlGF)
Recombinant a4 Fragment
Hepatocyte Growth Factor/ Scatter Factor (HGF/SF)
Angiogenin
Platelet Derived Endothelial Cell Growth Factor
Applications of Angiogenic Stimulators vis-à-vis Disease Perspective
Cardiac Diseases
Wound Healing and Burns
Critical Limb Ischaemia
Status of Angiogenic Inducers
Angiogenic Therapies for Tissue Repair & Regeneration
Select Devices Supporting Therapeutic Angiogenesis
Angiogenesis in Ischemic Heart
Factors Influencing Ischemic Angiogenesis
Angiogenesis and CAD
Angiogenesis in Wound Healing
Factors Stimulating Wound Angiogenesis
Factors Impairing Wound Angiogenesis
Angiogenic Therapy Vs. Conventional Therapy
Types of Angiogensesis
Excessive Angiogenesis
Insufficient Angiogenesis
Tumor Angiogenesis
Sequence of Actions
Angiogenesis and Tumor Progression
Oncogenes vis-à-vis Potential Pro-angiogenic Activities on Tumor Angiogenesis
Role of Angiogenesis in Skin Diseases
Select Drugs & Their Targeted Application
Analysis of Developmental Activities Between Decades
Role of Enzymes and Inflammatory Cells in Angiogenesis
Angiogenic Imbalance Augments Retinal Neovascularization
Oncogenes & VE –cadherin – A Facilitating Role

7.PRODUCT APPROVALS AND LAUNCHES

FDA Withdraws Approval of AstraZeneca’s NDA for IRESSA (gefitinib) Tablets
Pfizer Obtains European Approval for SUTENT® to Treat Pancreatic NET
Novartis Obtains FDA Approval of New Indication for Afinitor
FDA Approves Herceptin for Treating Metastatic Adenocarcinoma
Roche Introduces Avastin in China
Pfizer Japan Receives Clearance for Torisel in Japan
GSK Obtains European Commission’s Conditional Marketing Approval for Votrient
FDA Approves Tarceva® for Maintenance Treatment of NSCLC
FDA Approves GlaxoSmithKline’s Votrient
European Commission Grants Clearance to Torisel for Mantle Cell Lymphoma
Genetech Receives FDA Approval for Avastin in Renal Cell Carcinoma
FDA Approves Bevacizumab as Second Line Treatment for Glioblastoma
Novartis Obtains FDA Approval of Afinitor for Treating Renal Cell Cancer

8.PRODUCT APPROVALS AND LAUNCHES – A HISTORIC PERSPECTIVE BUILDER

FDA Grants Clearance for Gleevec in Treatment of Gastrointestinal Stromal Tumor
Celgene’s Thalidomide Pharmion™ Receives EC Clearance for Treating Multiple Myeloma
Genentech Obtains FDA Approval for Avastin in Breast Cancer
FDA Approves Nexavar for Treatment of Hepatocellular Carcinoma
Wyeth Receives EC Clearance for TORISEL in Advanced Renal Cell Carcinoma
OSI and Roche Announce Approval of Tarceva® in Japan
ImClone Obtains FDA Label Expansion for Erbitux®, as Third Line Therapy in mCRC
REVLIMID® Obtains Swissmedic Authorization in Switzerland
REVLIMID® Receives Marketing Approval in European Union
Wyeth Obtains FDA Clearance for Marketing Torisel
Chugai Obtains Approval for Avastin in Japan
Pfizer Obtains FDA Approval for Sunitinib in Metastatic Renal Cell Carcinoma
FDA Approves Herceptin in HER2-Overexpressing Breast Cancer Treatment
Genentech Receives FDA Approval for Bevacizumab in Non-Small Cell Lung Cancer
Amgen Obtains FDA Approval for Vectibix Treating mCRC
FDA Grants Marketing Approval for Lucentis in Wet AMD
Celgene Obtains FDA Clearance for Revlimid in Multiple Myeloma
FDA Approves Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer
Celgene Obtains FDA’s Accelerated Approval for THALOMID
Celgene Obtains sNDA Approval for THALOMID from FDA
ImClone Obtains FDA Clearance for Erbitux® in the treatment of SCCHN
Pfizer’s Sutent Receives FDA Nod for Treatment of Gastrointestinal Stromal Tumor
Celgene Receives FDA’s Subpart H Approval for Revlimid in Myelodysplastic Syndromes
US FDA Approves OSI’s Tarceva® for Treating Pancreatic Carcinoma

9.RECENT INDUSTRY ACTIVITY

Valeant to Take Over Eyetech
Teva Acquires Cephalo
Genentech to Carry Out Additional Trial of Avastin in Her2-negative mBC
Pfizer to Seek regulatory Clearance for Axitinib in Europe and US
FDA to Withdraw Avastin’s Approval for Breast Cancer
Eyetech Receives QTDP Grant To Develop Extended- Release Formulation of Macugen®
sanofi-aventis and Regeneron to Continue VELOUR Trial as Planned
EntreMed Enters into Financing Deal for ENMD-2076 Development
Chugai Pharmaceuticals Fulfills Condition for Avastin’s Approval
Gilead Sciences to Take Over CGI Pharma
Mersana Commences XMT-1107 Phase I Clinical Trial
Astellas Pharma Acquires OSI Pharmaceuticals
Roche to Conduct a Trial on Anti-Cancer Antibody TB-403
Mersana Therapeutics Inks License Agreement With Teva
Acceleron Publishes Pre-clinical Data Study on ACE-041
Antisense Raises Capital to Continue Phase III Trabedersen Trial
GSK Receives Positive Opinions from EMEA for Two Cancer Medicines
EMEA Issues Positive Opinion on GSK’s Votrient
EMEA Issues Positive Opinion on GSK’s Anti Cancer Drug Candidate, Tyverb
Abbott Enters into Licensing Agreement with Pierre Fabre
Arno Therapeutics Inks Global Licensing Agreement with OSU
BI Initiates Late Stage Clinical Trials for Two Oncology Drug Candidates
AnGes Obtains US FDA Approval for Phase III Trial of Collategene™
Silence Therapeutics and Intradigm Merge
Mersana Launches First Phase of XMT-1107 Clinical Trial
ImClone Receives Complete Response Letter for Erbitux® sBLA From FDA
Oxigene Releases Encouraging Data from OXi4503 Pre-clinical Studies
Potentia Enters into Licensing and Purchase Option Deal with Alcon
Quark Receives Additional Patents for RTP 801 Gene Targeting Compounds
Simcere Enters into Collaboration Deal with OSI Pharmaceuticals
Pfizer Acquires Wyeth in Cash & Stock Merger
Gene Signal Releases Interim Results from Phase II Study on GS-101
Onco to Conduct Second Phase Trial of Fuso's OTS102
Green Cross Obtains US FDA Approval for Greenstatin Clinical Trial
OXiGENE Acquire Symphony ViDA
Roche Releases Positive Results from Phase III Trial of Lucentis
Pfizer Halts Phase III Sutent Study for Colorectal Cancer
Morphotek Obtains FDA Clearance for MORAb-004 IND Application
GlaxoSmithKline Files MAA for Pazopanib in EU
Roche Acquires Genentech
Fuso Commences Phase II/III Clinical Trail for OTS102

10.STRATEGIC CORPORATE DEVELOPMENTS – A HISTORIC PERSPECTIVE BUILDER

EntreMed to Funnel Resources on ENMD-2076 Development
OmegaGenesis Enters Into Collaboration with Mayo Clinic for Angiogenesis Research
Eli Lilly Acquires ImClone Systems
EntreMed Demonstrates Antitumor Effects of ENMD-2076
EntreMed Collaborates with JSB for ENMD-2076 Business Development
Circadian Technologies Limited Acquires Vegenics
Fuso and OTS to Initiate Phase II Trial for OTS102
EntreMed Releases Pre-Clinical Findings of ENMD-2076 in Multiple Myeloma
Merck Serono Inks Development and Licensing Agreement with Bionomics
Roche Inks Licensing Agreement with ThromboGenics and BioInvent for TB-403
Aida Initiates Pre-Clinical Development of New Anti-Cancer Drug
Cyclacel Pharmaceuticals Releases Pre-Clinical Data of CYC116
Astellas and CoMentis Ink Agreement to Develop and Commercialize Beta- Secretase Inhibitors
Kringle Pharma’s NK4 Receives Patent Approval in Japan
UCB Releases Phase II Results of CDP791 in NSCLC Treatment
Celgene Takes Over Pharmion
REVLIMID® Obtains Orphan Drug Designation in Japan
TRACON Commences Phase I Clinical Trial on TRC105
Ark Therapeutics to Acquire Lymphatix
Access Takes Over Somanta
Pfizer Takes Over CovX
Callisto Restructures Licensing Agreement with Genzyme for Atiprimod
EntreMed Receives FDA Approval for ENMD-2076 IND Application
EC Grants Orphan Medicinal Status to REVLIMID for Treatment of CLC
Bristol-Myers Squibb Snaps Up Adnexus Therapeutics
Morvus Takes Over Two Companies
Merck Inks Agreement with BMS and ImClone for Erbitux® Development And Commercialization
FDA Issues a Safety Labeling Update for Bevacizumab Drug
Fuso Initiates Phase I Clinical Study for OST102 Angiogenesis Inhibitor
CRC to Support Bionomics in BN069 Development
Peregrine Secures Licensing Rights for B2GP1 Angiogenesis Inhibitor
AnGes’s Angiogenesis-Stimulating Drug Meets Primary End-Point in Phase III Study
ImClone Annuls Development Agreement with UCB
ArQule Partners with Kyowa Hakko in Cancer Compound
Samaritan Snaps Up Metastatin Pharmaceuticals
EU Approves €2 Million Grants for VASOPLUS Consortium
MGH Cancer Center Reports Results of AZD2171 Phase II Trial
AVEO Inks Exclusive Licensing Agreement with Kirin for Novel Anti-Cancer Compound
Sangamo and Edwards Ink Angiogenesis Asset Purchase Agreement
Covalon Secures Perfusion’s Gene Therapy Solutions
Vical Strengthens Angiogenesis and Poloxamers IPR Portfolio
Biomira Takes Over ProIX Pharmaceuticals
FDA Gives Out Warning on Bevacizumab Drug
Athenagen Merges with Zapaq
Tigris Secures Global Licensing Rights to Develop and Commercialize New Cancer Therapies
Bayer Yakuhin Files Marketing Application for Nexavar in Japan
Athenagen Purchases Assets of Osprey Pharmaceutical
Amgen Acquires Abgenix
Genmab Enters Exclusive Licensing Agreement with Bionomics
OSI Pharmaceuticals Acquires Eyetech Pharmaceuticals
FDA Changes Labeling of Iressa, Limiting Use to NSCLC
Schering AG and Novartis Signs a Agreement to Commercialize Angiogenesis Inhibitor, PTK787
Bausch & Lomb Signs an Option Agreement with PTC Therapeutics
Bausch & Lomb Receives License from Cephalon, Inc
Pharmacopeia Signs a Licensing Agreement with Allergan
Xantos Biomedicine and Cryptome Enters into Licensing Agreement
EntreMed Receives US Patent

11.FOCUS ON SELECT GLOBAL PLAYERS

Abbott Laboratories (USA)
Adnexus Therapeutics, Inc. (USA)
Æterna Zentaris Inc. (Canada)
Amgen, Inc. (USA)
Angstrom Pharmaceuticals Inc. (USA)
AstraZeneca Plc. (UK)
Bayer HealthCare AG (Germany)
Callisto Pharmaceuticals, Inc. (USA)
Celgene Corporation (USA)
Celltech Group Plc. (UK)
Cephalon Inc. (USA)
Eisai Inc. (USA)
Eli Lilly And Company (USA)
ImClone Systems Inc. (USA)
EntreMed Inc. (USA)
GenVec Inc. (USA)
Genzyme Corp. (USA)
GlaxoSmithKline Plc (UK)
Merck KGaA (Germany)
Novartis (Switzerland)
OSI Pharmaceuticals, Inc. (USA)
Eyetech, Inc. (USA)
Pfizer Inc. (USA)
Progen Industries (Australia)
Regeneron Pharmaceuticals
Roche (Switzerland)
Genentech Inc. (USA)
Chugai Pharmaceutical Co. Ltd. (Japan)
Silence Therapeutics
ThromboGenics Limited (Ireland)

12.GLOBAL MARKET PERSPECTIVE


III. MARKET

1.THE UNITED STATES

A. Market Analysis
Angiogenic Inhibitors
List of FDA Approved Anti-Angiogenic Drugs
Pipeline Status By Disease
Anti-Angiogenesis Therapeutics In Phase III Development for Renal Cell Carcinoma: As of 2010
Anti-Angiogenesis Therapeutics In Phase III Development for Breast Cancer Treatment: As of 2010
Angiogenesis Stimulators
Historical Market Snapshots
Market Influencers
Types of Drug Approvals
New Drug Approval (NDA)
Orphan Drug Act
Benefits Derived on Successful Grant of Orphan Drug Status
Angiogenesis Foundation
Key Role of the Foundation in Angiogenesis
The Rising Concern
Cancer
Cancer Statistics in US
A Picture of Colon Cancer in the US
Pancreatic Cancer
Vital Statistics


AMD and DME Incidence in the US
Rheumatoid Arthritis: Another Emerging Threat
Diabetic Retinopathy
Coronary Artery Disease (CAD)
Myocardial Infarction Statistics in the US
Peripheral Arterial Disease
B. Market Analytics


2.EUROPE

A. Market Analysis
Angiogenesis Market – A Historic Perspective
Cancer Trends


B. Market Analytics


3.REST OF WORLD

A. Market Analysis
Japanese Market
Quest for New Opportunities
B. Market Analytics


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 69 (including Divisions/Subsidiaries - 85)
The United States (50)
Canada (2)
Japan (3)
Europe (22)
- France (2)
- Germany (5)
- The United Kingdom (6)
- Italy (3)
- Rest of Europe (6)
Asia-Pacific (Excluding Japan) (8)