Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression Where do we go from here?

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1 Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression Where do we go from here? Heddie Martynowicz, MS Senior Director, Global Regulatory Affairs Janssen R & D

2 Unmet Medical Need for Novel MDD Treatments Major depression is a serious medical disorder Major depression will be #1 cause of disability worldwide by Current treatments for depression are suboptimal 2 Slow onset of effect: 4-8 weeks Only 30% of patients achieve remission 1. World Health Organization, Global Burden of Mental Disorders, Cleveland Clinic Journal of Medicine Volume 75 Number 1 January 2008.

3 CNS Drug Development is High Risk CNS drug development is challenging Increasing stakeholder requirements Some companies are exiting this area

4 CNS Program Portfolios in Large Pharma: 2009 vs Total Programs 2009= = Abbott/AbbVie AstraZeneca 21 7 Bristol-Myers Squibb 12 2 GlaxoSmithKline Johnson & Johnson Lilly 16 9 Merck/Schering-Plough 32 7 Novartis Pfizer/Wyeth Roche/Genentech Sanofi/Genzyme SOURCE: Neuron 84, November 5, 2014 ª2014 Elsevier Inc. Total number of discovery, preclinical, and clinical drug development programs addressing neurology or psychiatry disease targets, visible from publicly available sources including SEC filings, investor briefings, and company websites. 4

5 Regulatory Guidelines Shape Global Drug Development MDD clinical trial challenges High placebo response Selecting appropriate patients Drug adherence Regulatory guidelines provide useful information to manage MDD development uncertainties Regulatory depression guidelines FDA, 1977 EMA CHMP, 2002/2013 China FDA, 2013

6 First came into effect in 2002 Revised draft for comment in Sept 2011 Final/current version effective Dec 2013 Expanded guidance for augmentation therapy

7 Current CHMP Depression Guideline Recommendations Augmentation/add-on Treatment For patients with partial response to monotherapy A run-in period alone with assessment of response to standard intervention may not be sufficient Instead an initial randomization to standard medication or placebo would be the best way to characterize the proportion of the population that were partial responders Inclusion of a monotherapy arm of the test product should be considered Treatment resistant depression (TRD) Partial responders can be distinguished from full non responders (TRD) Lack of clinically meaningful improvement following treatment with at least two different antidepressant agents (of the same or a different class) prescribed in adequate dosages for adequate duration and adequate affirmation of treatment adherence At least one treatment failure should be shown prospectively TRD patients are not suitable for augmentation therapy

8 Program Focus European based pharmaceutical industry expects challenges in implementing CHMP guideline recommendations European Federation Pharmaceutical Industry Association (EFPIA) White Paper Aug 2014 Open science-based discussion taking into account perspectives from various stakeholders Regulators Clinicians Academicians Pharmaceutical industry

9

10 18 February 2015 Session 3: Challenges in Developing Therapeutics in Partially Responsive and Treatment Resistant Depression Where do we go from here? 1:45 Introduction to the Session Heddie Martynowicz Janssen, Regulatory Affairs 2:00 Clinical Perspective on Conducting Adjunctive MDD Studies Justine Kent Janssen, Clinical Development 2:30 Clinical Perspective on Conducting TRD Studies Hans Erikkson Lundbeck, Clinical Development 3:00 Break 3:20 Regulatory Perspective CHMP Karl Broich Federal Institut for Drugs and Medical Devices 3:50 Advancing Our Thinking About Adjunctive MDD and TRD Thomas Laughren Laughren Psychopharm Consulting, LLC 4:20 Panel Discussion Panel members: Mitch Mathis - FDA J. Craig Nelson - UCSF Allies Muslin - ADAA Justine Kent Hans Erikkson Karl Broich Thomas Laughren 5:15 Meeting Adjourns

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