LATUDA Commercial Update LATUDA Meeting (Tokyo) January 2011 Mark - - PowerPoint PPT Presentation

LATUDA Commercial Update

LATUDA Meeting (Tokyo)

January 2011 Mark Iwicki President and Chief Operating Officer Sunovion Pharmaceuticals Inc.

1

Sunovion Is Uniquely Positioned to Deliver Strong Performance for LATUDA

Overall market growth is stable and unmet needs remain

• Efficacy is key reason to prescribe
• High switch and discontinuation rates

Strong clinical profile and competitive LATUDA label

• Inclusion of olanzapine arm in efficacy and weight data sections (as an

active control to assess assay sensitivity)

• 4 positive efficacy studies
• Two dose options, once-daily
• 2,000+ safety database
• No QTc warning

336 dedicated and experienced Sales Force

• Majority have previously sold at least 1 other atypical antipsychotic

Customer-centric commercial organization

• Focus on engaging psychiatrists through multimodal approach
• Competitive pricing and reimbursement strategies

2

Atypical Antipsychotic Market Growing at 3%

15,324 16,237 17,202 14,169 14,735 15,045 9,121 8,647 8,373 5,847 6,644 6,522 2,120 2,372 2,373 10,000 20,000 30,000 40,000 50,000 60,000 MAT Nov 2008 MAT Nov 2009 MAT Nov 2010 TRx (000s) Bipolar Disorder Schizophrenia All others Depression Anxiety

Source: Derived from IMS NPA Data, and SDI PDDA

47MM 49MM 50MM 3% Market 6% Bipolar Disorder 3% Schizophrenia

• 4%

All others 6% Depression 6% Anxiety CAGR DX

Growth in the Atypical Antipsychotic Category Is Being Driven by Use in Bipolar Disorder and Depression

$15.8BN Market

3 Source: IMS NPA. The Atypical antipsychotic market is defined as ANTIPSYCHOTICS, OTHERS (USC 64190), excluding Haldol, Loxapin, Moban, Navane, Orap, and Thiothixene, etc.

Monthly Antipsychotic Market TRx Share Trend

0% 5% 10% 15% 20% 25% 30% 35% 40%

D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N

TRx Share Seroquel Risperidone Abilify Zyprexa Geodon Seroquel XR Saphris Fanapt

Established Market

2007 2008 2009 2010

4

37 39 39 49 66 49 53 80 25 50 75 100

Psychiatrists Need New Treatments that Provide a Combination of Strong Efficacy and Tolerability

Higher Importance Effective in Treating Positive Symptoms

Efficacy

Low Incidence of Extrapyramidal Side Effects Effective in Treating Negative Symptoms Does Not Cause Significant Weight Gain Good patient compliance Well Tolerated

Tolerability

Safe for Long-Term Therapy

Safety

Effectively controls agitation/aggression Medium Importance Percent of Psychiatrists

Source: GfK, 2009 Schizophrenia Physician Study

5

No Single Preferred Agent for Treatment of Schizophrenia

FANAPT 0.1% Invega Sustenna 0.2% Seroquel XR 5.4% Seroquel 29.5% Risperidone 22.1% Geodon 6.7% Abilify 19.8% Zyprexa 10.3% Risperdal 0.5% Saphris 0.3% Risperdal Consta 0.9% Invega 1.8%Clozapine 2.6% Fanapt 0.2% Geodon 8.4% Risperidone 21.2% Seroquel 18.0% Clozapine 10.0% Zyprexa 16.5% Abilify 13.5% Invega Sustenna 0.8% Saphris 0.4% Invega 3.2% Seroquel XR 3.8% Risperdal Consta 4.1%

Schizophrenia Uses MAT Sept 2010 All Uses MAT Sept 2010

Source: Wolters Kluwer Source Lx Based on Market Research

6

High Discontinuation Rates Create Opportunity for LATUDA

CATIE Reinforced Need for New Treatment Options

• 74% of patients discontinued the

study medication before 18 months

Patients dissatisfied with current options

• Continue to experience

breakthrough symptoms

• Discontinue due to adverse

events, lack of efficacy

• Likely to have tried multiple

medications

“Two drugs, olanzapine and clozapine, appear to be more effective than other

• agents. However, both drugs induce a

significantly greater number of serious side

• effects. Even the most feared side effect…

tardive dyskinesia, seems less troubling than potentially fatal metabolic problems.” – Robert Freedman, MD, NEJM “Two drugs, olanzapine and clozapine, appear to be more effective than other

• agents. However, both drugs induce a

significantly greater number of serious side

• effects. Even the most feared side effect…

tardive dyskinesia, seems less troubling than potentially fatal metabolic problems.” – Robert Freedman, MD, NEJM

7

Leverage Strong Clinical Profile and Positive Label

Opportunity to improve value proposition vs. current atypical antipsychotics

• Once-daily with food
• The recommended starting dose

is the therapeutic dose – 40 mg

• LATUDA offers proven efficacy

with positive cardiometabolic profile

• No QTc warning

Differentiate from current atypical antipsychotics that offer partial efficacy/response

• 4 positive efficacy studies included in label
• Efficacy confirmed for both doses in 2 studies each

8

Psychiatrists Are Key Driver for Launch

A large and stable market with ~2 million patients with Schizophrenia in the US Our current target audience ~22,000 psychiatrists 336 Sales Force will cover target audience and will be able to attain competitive share of voice by focusing on these specialists

Schizophrenia Treatment by Specialty

PCP & Others, 3% Psych, 97% Neuro 0.5%

Source: SDI PDDA

9

Leverage Dedicated and Experienced Sales Force Ready to Deliver on the Potential of LATUDA

Sales force: 336 Hospital sales force: 70 Extensive experience selling in the atypical antipsychotic arena Dedicated and qualified Area Medical Specialists team Managed care and Government Affairs team with strong category knowledge

10

Sunovion Is Uniquely Positioned to Deliver Strong Performance for LATUDA

Unsatisfied physician and patient population as evidenced by high switch rates creates opportunity for LATUDA LATUDA has a strong clinical profile and competitive label Dedicated and experienced Sales Force ready to compete Focused on key access issues to ensure success

11

Disclaimer Regarding Forward-looking Statements

The statements made in this presentation material are forward-looking statements based on management’s assumptions and beliefs in light

• f information available up to the day of announcement, and involve

both known and unknown risks and uncertainties. Actual financial results may differ materially from those presented in this document, being dependent on a number of factors. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.