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Monoclonal Antibodies Special Report Part 1

mAb Reports: Part 1 | Part 2

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Therapeutic Monoclonal Antibodies - Insights, Strategies and Data
How U.S. Biotechnology Companies Pioneered the Path to Clinical, Regulatory and Market Success for Monoclonal Antibodies

Monoclonal antibodies (mAbs) have become one of the most valuable and rapidly growing segments of the worldwide pharmaceutical industry. In 2010, sales of the top ten selling mAbs in the world reached $36 billion. Moreover, their unique ability to bind to specific antigens within human cells, tissues and organs has allowed nine of them to dominate targeted cancer drug sales growth in the last five years. Based on highly curated data and featuring one-of-a-kind analytics, Deloitte Recap’s special two-part report offers a new perspective on monoclonal antibodies.

In great detail, Part 1 profiles key clinical development metrics for therapeutic monoclonal antibodies, both marketed and in the clinical pipeline, and examines strategies used by successful mAb companies to pave a now established road to help drive clinical, regulatory and market success for this important therapeutic class. Key questions answered:

• What are the top therapeutic and molecular targets of mAbs in the pipeline?
• How many years of clinical development and regulatory review should a company expect in developing mAbs?
• Which therapeutic areas do mAbs have greatest chances of success for transitioning from Phase I to Market?
• Which FDA regulatory mechanisms have actually shortened mAb development times?
• What kind of safety programs has the FDA mandated for mAbs?
• What is the probability of success for mAbs by therapeutic area?
• When and why do most mAbs terminate during development?
• What “landing indications” for mAbs have resulted in successful development strategies?

Sample data from Therapeutic Monoclonal Antibodies – Insights, Strategies and Data:
Mean clinical development and FDA review times by regulatory mechanism for 28 mAbs approved by FDA between January 1994 and March 9, 2011*

FDA mechanism	n (%)	Clinical development (yrs)	FDA review (yrs)	Total product development (yrs)
Fast Track	10 (36)	7.2	1.1	8.3

Non-Fast Track	18 (64)	6.2	1.1	7.3

Accelerated Approval	8 (29)	6.7	1.0	7.7

Traditional Approval	20 (71)	6.4	1.1	7.5

Orphan Drug Status	11 (39)	6.5	0.9	7.4

Non-Orphan Status	17 (61)	6.5	1.2	7.7

Priority Review	19 (68)	6.6	0.8	7.4

Standard Review	9 (32)	6.3	1.6	7.9

0 Mechanisms Used	9 (32)	6.3	1.6	7.9

1–4 Mechanisms Used	19 (68)	6.6	0.8	7.4

ALL — Means	28	6.5	1.1	7.6

Data Source: Deloitte Recap LLC
*Data missing for Orthoclone OKT3 (1986 FDA approval). Note: Development and review times for three mAbs subsequently withdrawn from the U.S. market (Mylotarg, Raptiva, Zenapax) are included in means reported here.

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Materials Included
• Interactive PDF of report with hyperlinked references and data sources
• PowerPoint file of Figures
• Excel file with detailed data from Deloitte Recap’s source data

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• USD $760 Single User License
• USD $1,900 Multi User License