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FDA Approval Percentages Handout
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BIO CEO & Investor ConferenceFebruary 15th, 2011
BIO / BioMedTrackerClinical Trial Success Rates Study
Michael Hay, Senior Biotechnology Analyst, SagientResearch Systems
Jesse Rosenthal, Senior Biotechnology Analyst, SagientResearch Systems
David Thomas, Director, Industry Research & Analysis, Biotechnology Industry Organization (BIO)
John Craighead, Ph.D., Managing Director, Investor Relations & Business Development, BIO
MOST RECENT STUDIES
• 1,738 drugs(Only Lead indications)
• Must have entered into a Phase I 1993-2004
• Developed by the 50 largest Pharmas
TUFTS 2010*
• 4,275 drugs• 7,300 indications
(All indications)
• Any Phase during Oct 2003- Dec 2010
• All companies, Biotechs + Pharma including Private
BioMedTracker 2011
* DiMasi, et al. Nature Clinical Pharmacology and Toxicology, May 2010
21%19%
9%
14.5%
3.2%
Tufts '03 BMT Secondary Indications
OVERALL SUCCESS RATES
Tufts ’03Lead
Indications
BMTAll
Indications
BMTLead
Indications
BMTSecondaryIndications
21%19%
9%
14.7%
3.3%
Tufts '03 Tufts '10 BMT Lead Non-LeadTufts ’10Lead
Indications
*
* DiMasi, et al. Nature Clinical Pharmacology and Toxicology, May 2010
CALCULATING OVERALL SUCCESS RATES(simple compounded probabilities)
.63 x .33 x .55 x .80 = .09
Phase TransitionPhase
Success
Phase
LOA
P1 to P2 63% 9%
P2 to P3 33% 15%
P3 to NDA/BLA 55% 44%
NDA/BLA to Approval 80% 80%
LOWER SUCCESS WITH SECONDARY INDICATIONS AT EACH PHASE
14%
26%
41%
3%7%
10%
NME Biologic Non-NME
Lead Indications
Secondary Indications
14%
26%
41%
3%7%
10%
NME Biologic Non-NME
Lead Indications
Secondary Indications
OVERALL SUCCESS RATES BY MOLECULE TYPE
15%14%
12%13%
12%
7%
11%
3%2%
7%
2%4%
3% 2%
Lead Indications Secondary Indications
OVERALL SUCCESS BY DISEASE
OVERALL SUCCESS AT PHASE II AND III
OVERALL SUCCESS RATES - ONCOLOGY
2%
3%
3%
4%
6%
6%
7%
7%
8%
15%
19%
0% 5% 10% 15% 20%
NSCLC
MDS
Colorectal Cancer
Prostate Cancer
CLL
HCC
Multiple Myeloma
Breast Cancer
Ovarian Cancer
RCC
Head and Neck
“IF AT FIRST YOU DO NOT SUCCEED…TRY, TRY AGAIN”
51%
87%
64%
78%
49%
75%
40%
50%
60%
70%
80%
90%
100%
First Second Third Fourth Fifth
Lead Indications Secondary Indications NME
Trial and Error: Breaking Down Clinical Trial Success Rates
13th ANNUAL BIO CEO INVESTOR CONFERENCETuesday, February 15th
12:00 - 12:55 pm, Jade RoomModerator:• David Strupp, Managing Director, Rodman & Renshaw, LLC
Panelists:• Ted Buckley, PhD, Chief Economist, Bloomberg• Lawrence T. Friedhoff, MD, PhD, FACP, CEO, Pharmaceutical Special Projects Group, LLC • Michael Hay, Senior Biotechnology Analyst, Sagient Research Systems• David Thomas, Director, Industry Research & Analysis, BIO
BIO INDUSTRY ANALYSISwww.insidebioia.com
VISIT US @
BioMedTrackerwww.biomedtracker.com
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