Lipha Pharmaceuticals, Inc.

1
Lipha Pharmaceuticals, Inc.

• May 10, 2002
• Psychopharmacologic DrugsAdvisory Committee
  Meeting

2
Introduction

• Anita M. Goodman, M.D.
• Executive Vice-President and COO
• Lipha Pharmaceuticals, Inc.

3
The Toll of Alcohol Dependence

• Over 8.1 million alcohol-dependent people in the
  United States
• Economic cost 185 billion per year
• 100,000 deaths per year

From Fuller, R.K., Gordis, E.Editorial
Naltrexone Treatment for Alcohol DependenceNEJM
3451770-1771, 2001
4
Pharmacotherapy and Alcoholism

• Paucity of available approved medications
• Disulfiram (aversive agent)
• Naltrexone (opioid antagonist)
• Lingering resistance to treatments other than
  psychotherapeutic
• Lack of universally accepted outcome criteria

5
European Development Program and Current
Registration Status

• Sylvie Chabac, M.D.International Project
  ManagerLIPHA s.a.s.Lyon, France

6
Why Pivotal?

• Qualities of All Studies
• Study conducted by qualified investigators
• Study conducted according to existent Good
  Clinical Practice standards
• Study conducted according to specified protocol
• Existent case report forms
• Electronic data base

Source ISE Section 8.7.1.2.3
7
Why Pivotal?

• Additional Qualities of Selected Studies
• Study centers still active, with accessible
  medical records and source documents (permitting
  site audit by FDA)
• CROs still active
• 2 dosage levels

Source ISE Section 8.7.1.2.3
8
Acamprosate Mechanism of Action, Preclinical
Effects, and Pharmacokinetic Overview

• George F. Koob, Ph.D.Professor, Department of
  NeuropharmacologyDirector, Division of
  NeuropharmacologyThe Scripps Research
  InstituteLa Jolla, CA

9
Efficacy Results from Three Pivotal Efficacy
Trials

• Karl F. Mann, M.D.Professor and
  ChairmanDepartment of Addictive Behaviour and
  Addiction MedicineCentral Institute of Mental
  Health of MannheimUniversity of
  HeidelbergMannheim, Germany

10
Analysis of the US Study Results

• Barbara J. Mason, Ph.D.Professor, Department of
  Psychiatryand Behavioral SciencesDirector,
  Division of Substance AbuseUniversity of Miami
  School of MedicineMiami, FL

11
Acamprosate Issues

• Why were the efficacy results from the US trial
  inconclusive in contrast to the consistently
  positive European studies?
• Were the methodologies in these trials
  appropriate?
• Are alcohol dependent populations in Europe and
  the United States comparable?