Monoclonal Antibodies: what the future holds

Table of Contents

EXECUTIVE SUMMARY

• The Integration of Monoclonal Antibody Therapies into the Healthcare Marketplace
• Antibody Libraries Fuel Pipelines
  • Antibody Technology Partnerships with Big Pharma
• Future Trends

Monoclonal Antibodies in Oncology

• The Global Oncology Market
  • Global Cancer Drug Sales (including supportive care) in 2005 (US$42 billion)
• Sales and Future Growth Drivers
• Genentech: A Case Study in Anti-Cancer Antibodies and Commercial Success
  • Roche/Genentech MAb Revenues 2005-2006
  • MabThera/Rituxan Projected Sales (2000A-2010E)
  • Herceptin Projected Sales (2001A-2011E)

Analysis of Monoclonal Anti bodies in Phase II or Phase III Deve lopme nt for Cancer

• Key Evaluation Criteria
  • Summary of Key Monoclonal Antibody Therapies in Clinical Development for the Treatment of Cancer
• HuMax-CD4 (zanolimumab)
• Genmab/Merck Serono
  • Novelty/rationale for mechanism of action
  • Proof of Concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic area
  • Filings and approval
  • Competitor Ratio Analysis
• Rencarex
• Wilex/Centocor
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Ticilimumab (CP675, 206CTLA-4)
• Pfizer/Amgen
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Catumaxomab
• Fresius Biotech/TRION Pharma
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Anti-Cancer Antigen 125
• (ACA 125, VaccinOvar)
• CellControl Biomedical Ag (Phase I/II)
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition in the market
  • Risks associated with development
  • Filings and approvals
  • Competitor Ratio Analysis
• Adecatumumab (MT201)
• Micromet/Merck Serono
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical experience
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Antibody 3F8 (anti G CD2)
• Memorial Sloan Kettering Cancer Center (MSKCC)
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• HuN901-BM1
• ImmunoGen
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• BrevaRex (mAb-AR20.5)
• Unither Pharmaceuticals and Virexx
  • Novelty/rationale for mechanism of action
  • Proof of Concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with the developing a drug within a therapeutic class
  • Filings and approvals
  • Competitor Ratio Analysis
• CNTO328
• Centocor
  • Novelty/rationale for mechanism of action
  • Proof concept/clinical of data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and Approvals
  • Competitor Ratio Analysis
• Cotara
• Peregrine Pharma
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Daclizumab
• PDL BioPharma/Roche
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• EMD 72000 (Matuzumab)
• EMD Pharmaceuticals, Merck and Takeda
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical trials
  • Competition within the marketplace
  • Management/clinical expertise
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Epratuzumab
• Immunomedics
  • Novelty/rationale for mechanism of action
  • Proof of Concept/Clinical Trials
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Ertumaxomab
• Fresius Biotech/TRION Pharma
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Galiximab (anti CD-80)
• Biogen Idec
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Competition within the marketplace
  • Management/clinical expertise
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• HA20 or IMMU-106
• Immunomedics
  • Novelty/rationale for mechanism of action
  • Proof of Concept/Clinical Data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approvals
  • Competitor Ratio Analysis
• HuMax-CD20 (ofatumumab)
• Genmab
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approvals
  • Competitor Ratio Analysis
• HuMax-EGFr
• Genmab
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within the therapeutic class
  • Filings and Approvals
  • Competitor Ratio Analysis
• KW-2871
• Kyowa Pharmaceuticals
  • Novelty/rationale for mechanism of action
  • Proof of Concept
  • Management/Clinical Expertise
  • Competition in the marketplace
  • Risks associated with development of a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Lumiliximab
• Biogen-Idec
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical experience
  • Competition in the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• MDX 010 (Ipilimumab)
• Bristol-Myers Squibb
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition in the marketplace
  • Risks associated with development of a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• MDX-060
• Medarex
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and Approval
  • Competitor Ratio Analysis
• Medi 522 (Abegrin)
• MedImmune
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition with the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• OvaRex (oregovomab)
• Unither and Virexx
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and Approval
  • Competitor Ratio Analysis
• SGN-30 (anti-CD30)
• Seattle Genetics
  • Novelty/rationale for mechanism of action
  • Proof of Concept/clinical data
  • Management/Clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within the therapeutic class
  • Filings and approvals
  • Competitor Ratio Analysis
• Volociximab
• PDL BioPharma
  • Novelty/rationale for mechanism of action
  • Proof of concept/clinical data
  • Management/Clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approvals
  • Competitor Ratio Analysis

Monoclonal Antibodies in Rheumatology

• ANTI-RHEUMATIC DRUG SALES
• Rheumatoid Arthritis
  • Rheumatoid Arthritis Sales Drivers
  • Rheumatoid Arthritis Sales Breakers
  • Monoclonal Antibody Therapies on the Market for Rheumatoid Arthritis
    • Enbrel Projected Sales (2001A-2011E)
    • Remicade Projected Sales 2006-2015 (US$ million)
    • Humira Projected Sales (2000A-2010E)
    • MAb Therapies on the Rheumatology Market

Analysis of Monoclonal Antibodies in Phase III Deve lopment for Rheumatology

• MAbs in Phase III Development for Rheumatology Indications
• Certolizumab pegol (Cimzia)
• UCB
  • Mode of Action
  • Proof of Concept
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug in this class
  • Filings and approval
  • Competitor Ratio Analysis
• Golimumab (CNTO 148)
• Centocor/Schering Plough
  • Mode of Action
  • Proof of Concept/Clinical Data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• Tocilizumab (Actemra)
• Chugai Pharma/Roche
  • Mode of Action
  • Proof of Concept/Clinical Data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis

Analysis of Monoclonal Antibodies in Phase II Development for Rheumatology

• MAbs in Phase II Development for Rheumatology
• Belimumab (Lymphostat B)
• Human Genome Sciences/GSK
  • Mode of Action
  • Proof of Concept/ Clinical Data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug in the therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis
• HuMax CD-20 (Ofatumumab)
• Genmab
  • Mode of Action
  • Proof of Concept/Clinical Data
  • Management/clinical expertise
  • Competition within the marketplace
  • Risks associated with developing a drug within a therapeutic class
  • Filings and approval
  • Competitor Ratio Analysis

Competitor Ratio Analysis Sumary

• Competitor Ratio Analysis - Drugs
  • MAb Drugs Expected to Launch by 2012 - Initial Therapeutic Indication - Oncology
  • MAb Drugs Expected to Launch by 2012 - Initial Therapeutic Indication - Rheumatology
• Competitor Ratio Analysis - Companies
  • The Winners: Companies & MAbs with a CRA Score of 80% and Above