fda approval percentages handout

12
BIO CEO & Investor Conference February 15 th , 2011 BIO / BioMedTracker Clinical Trial Success Rates Study Michael Hay, Senior Biotechnology Analyst, Sagient Research Systems Jesse Rosenthal, Senior Biotechnology Analyst, Sagient Research Systems David Thomas, Director, Industry Research & Analysis, Biotechnology Industry Organization (BIO) John Craighead, Ph.D., Managing Director, Investor Relations & Business Development, BIO

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FDA Approval Percentages Handout

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Page 1: FDA Approval Percentages Handout

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

Page 2: FDA Approval Percentages Handout

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

Page 3: FDA Approval Percentages Handout

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

Page 4: FDA Approval Percentages Handout

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%

Page 5: FDA Approval Percentages Handout

LOWER SUCCESS WITH SECONDARY INDICATIONS AT EACH PHASE

14%

26%

41%

3%7%

10%

NME Biologic Non-NME

Lead Indications

Secondary Indications

Page 6: FDA Approval Percentages Handout

14%

26%

41%

3%7%

10%

NME Biologic Non-NME

Lead Indications

Secondary Indications

OVERALL SUCCESS RATES BY MOLECULE TYPE

Page 7: FDA Approval Percentages Handout

15%14%

12%13%

12%

7%

11%

3%2%

7%

2%4%

3% 2%

Lead Indications Secondary Indications

OVERALL SUCCESS BY DISEASE

Page 8: FDA Approval Percentages Handout

OVERALL SUCCESS AT PHASE II AND III

Page 9: FDA Approval Percentages Handout

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

Page 10: FDA Approval Percentages Handout

“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

Page 11: FDA Approval Percentages Handout

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

Page 12: FDA Approval Percentages Handout

BIO INDUSTRY ANALYSISwww.insidebioia.com

VISIT US @

BioMedTrackerwww.biomedtracker.com