Abstract
This new management report covers 30 leading compounds and is essential reading for everyone working in the field.
After years of anticipation and encouraging responses to pathfinder products, monoclonal antibodies are now set to realise their true clinical and commercial potential. But what are the prospects for the products that will lead the market?
The position of monoclonal antibodies on the market is solidly poised for growth with six novel therapies expected to launch within the next five years. The ability to be an effective medicine puts antibodies, and the companies having a hand in their development, into a position to create new markets. Buoyed by ticilimumab and ipilimumab, the treatment of melanoma will be among the first to follow the current blockbuster successes in breast cancer and leukaemia. Companies with pipelines to sell or in development, such as Genmab, Immunomedics and Seattle Genetics, have attracted capital from large pharmaceutical companies and investors.
HUGE POTENTIAL
While large pharma companies predictably take aim at the largest treatable populations (breast cancer, colorectal disease, NHL, leukaemia), there is an abundance of niches for monoclonal antibody therapy applications and a staggering number of potential disease targets. Smaller developer companies are likely to become more visible as their products move closer to regulatory approval.
That is why this new management report is essential for everyone working in the field. The report covers over 30 leading compounds originating from the largest blue-chip multinationals to smaller developer companies.
KEY EVALUATION FOR EACH PRODUCT
It is vital that new compounds can be seen in the wider competitive/development landscape. For that reason we have established a unique competitor analysis based on each of the following criteria:
- 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
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
