1

Copyright:

W. Michael Scheld, M.D.

2

Infectious Diseases Society of America (IDSA) – Antimicrobial Availability Task Force (AATF)

W. Michael Scheld, MD

University of Virginia

March 2004

3

IDSA/PhRMA/FDA Workshop; November 2002: Themes

“Delta”

Antibacterial resistance increasing

Antibacterial R&D declining

PK/PD; surrogate endpoints

AECB; meningitis; HAP

4

The perception

1998 2004

YEARS

Antibacterial resistance

Antibacterial R&D.

5

6

Threats to antibacterials

Bacterial resistance

Drug shortages

Dry pipeline

Void in public policy

7

Antimicrobial Research and Development

Spellberg et al

0

2

4

6

8

10

12

14

16

1983-1987

1988-1992

1993-1997

1998-2002

2003

Total # NewAntibacterialAgents (5 yearintervals)

8

New Antibacterials Approved (1996-2003)

1996 1997 1998 1999 2000 2001 2002 2003

Actual NumberApproved

9

• In 2002, out of 89 new drugs, no new antibacterial drugs were approved.

• Only about 5 new antibacterials in the drug pipeline, out of more than 400 agents in development*

*According to annual reports of 15 major pharmaceutical companies

Antimicrobial Availability

10

New Antibacterial Agents

Approved Since 1998 Spellberg et al

ANTIBACTERIALrifapentine quinupristin/dalfopristinmoxifloxacingatifloxacinlinezolidcefditoren pivoxilertapenemgemifloxacindaptomycin

YEAR 1998 1999 1999 1999 2000 2001 2001 2003 2003

NOVEL No No No No Yes No No No Yes

11

Phase III antibacterial development, December 2003 (NDA Pipeline;

“pink sheet”)ABT-773

Afelimomab

Tigecycline

(vs 18 novel oncology agents)

12

IOM report, 2003

“Unfortunately, complacency toward infections diseases in the 1960’s, overconfidence in existing antibiotics, and competition from highly profitable opportunities for pharmaceutical development and sale in other fields of medicine resulted in a lag in the production of new classes of antibodies. This occurred despite significant advances in the fundamental science that has fueled pharmaceutical innovation in many other areas”

13

IDSA Antimicrobial AvailabilityTask Force Charge

“Develop novel public policy to ensure a sustainable supply of safe and effective antimicrobial drugs to protect public health”

14

TASK FORCE MEMBERSJohn G. Bartlett, MD, Chair

John Hopkins Univ. SOM

Baltimore, MD

Johns S. Bradley, MD

Children’s Hospital-San Diego

San Diego, CA

John E. Edwards, MD

Harbor/UCLA School of Medicine

Torrance, CA

David N. Gilbert, MD

Providence Portland Medical Center

Portland, OR

W. Michael Scheld, MD

University of Virginia Medical Center

Charlottesville, VA

David M. Shlaes, MD

Idenix – ID Research

Cambridge, MA

George H. Talbot, MD

Talbot Advisors

Wayne, PA

Francis P. Tally, MD

Cubist Pharmaceuticals, Inc

Lexington, MA

David B. Ross, MD

Food and Drug Administration

Rockville, MD

John H. Powers, MD

Food and Drug Administration

Rockville, MD

15

IDSA – AATFWork plan

Understand the problem

Publish research; findings

Discuss with stakeholders

“Field trips”

Produce “white paper”

Develop solutions

16

The Public Health Service Action Plan to combat antimicrobial

resistance (CDC, NIH, FDA, etc.) October 2001

Stimulate development priority products to combat antimicrobial resistance

Streamline regulatory process

Identify incentives for development

17

Defining the Problem:“Bad Bugs, No Drugs”

• Input sought from major stakeholders:– IDSA’s membership base of 7,500 physicians,

researchers, and health care providers– FDA– CDC, NIAID, HHS– Senior pharmaceutical executives– Venture capital companies– Legislators

18

Defining the Problem:“Field Trips”

Abbott NIAID

BMS HHS

GSK CDC

Novartis FDA

Pfizer Congress

Vicuron

Others, including venture capital

19

Placebo-controlled trial of AECB

IDSA, ATS joint task force

Develop protocol and budget

Implement network

Submit to NIAID for funding