Paxil: New Indication, New Patients to Help

Do more, feel better, live longer

Talk to your doctor about how PAXIL can give you the confidence to quit

smoking, once and for all.THINK YOU ARE ADDICTED TO

SMOKING?Get a better idea in just a few minutes.KNOW YOUR PAXIL DOSING

OPTIONS.PAXIL has four dosing options to help you on

your path towards a smoke free lifestyle. Flexible dosing helps ensure that you have the most support when taking your life back from

smoking addiction.

PAXIL: New Indication, New Patients to HelpTreatment of Smoking Cessation with SSRIs

Presented by: Anthony Fisch, Christian O’Brien, Kellie Harris, Susan Le and Michael Walsh


Tactical Plan for Repositioning PAXIL

Marketing Position Overview (Incidence & Prevalence of Smoking, Discussion of Target Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share of Voice and Marketing Plan)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Events of Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendations about future research)Marketing BudgetQ & A


“Cigarette smoking is

associated with some anxiety

disorders.”Source: Journal of American Medical Association


Marketing Position

•Research has shown a positive association between cigarette smoking and anxiety, currently little is known about the underlying association.

•Positioning Statement: PAXIL can be used to treat patients suffering from Social Anxiety Disorder who want to quit smoking.


•Cigarette smoking causes about 1 of every 5 deaths in the United States each year.

•443,000 deaths annually (including deaths from secondhand smoke)

•49,400 deaths per year from secondhand smoke exposure

•269,655 deaths annually among men

•173,940 deaths annually among women

Smoking Statistics


What is PAXIL?•PAXIL (generic name: paroxetine hydrochloride) is an antidepressant medication that may be prescribed for bipolar depression, major depressive disorder, social anxiety disorder, panic disorder and obsessive compulsive disorder (OCD).

•Side effects are minimal and the benefits are numerous.

•The antidepressant market is one of the most saturated markets in the pharmaceutical industry and PAXIL holds a marginal market share, while still maintaining $1 billion annual revenue.

•The smoking cessation indication will bolster PAXIL’S positioning and help expand the general population’s overall confidence in PAXIL.


Can PAXIL Prevent Death?

• Smoking is the leading preventable cause of death.• If PAXIL can be introduced to an at-risk patient early enough, PAXIL can prevent death.•Worldwide, tobacco use causes more than 5 million deaths per year, and current trends show that tobacco will cause more than 8 million deaths annually by 2030.


Tactical Plan for Repositioning of PAXIL

Marketing Position Overview (Incidence & Prevalence of Smoking, Discussion of Target Market)Market Dynamics (Pipeline Analysis, Chantix Case Study, Discussion of Share of Voice)New Indication (Medical Guidelines for Smoking Cessation, Timeline of Events of Social Anxiety Disorder in SSRI treatment)Patient Flow Analysis (Influence on Treatment, Recommendations)Objectives for Research (Questionnaire for patients & KOLs, Recommendations about future research)Marketing BudgetQ & A


Pipeline Analysis of Smoking Cessation/Drug Dependency Therapies in Current Market

GlaxoSmithKlinePipeline Analysis 2008-2010

Drug ID Disease State

2008 2009 2010

598809 Drug Dependency

Phase I

618334 Drug dependency

Phase I

Phase I

468816 Smoking cessation

Phase II

In 2009, GSK stopped funding research for smoking cessation drugs because OTC sales were down 12%.

However, in 2010, although research was not implemented for smoking cessation treatment, in light of a hefty tobacco tax in Japan and a government sponsored smoking cessation program in Brazil, GSK was able to record 3% increase in OTC sales in the smoking cessation category.

PfizerPipeline Analysis 2008-2010

•Pfizer had its smoking cessation drug Chantix approved in 2006, making it the first prescription smoking cessation medicine to be approved in 10 years•By 2008, Chantix/Champix (trade name outside of US) had lost 4% in sales and was bringing in $846 million•2009: Chantix/Champix is still the leading pharmaceutical for smoking cessation in the world. •Pfizer supports smoking cessation projects in 46 countries•Chantix was not mentioned in the 2010 Annual Report.


Case Study: ChantixCompetitive Advantages and Lessons Learned

Chantix

Chemical name: Verenicline (nicotine blocker)

Competitive advantages

1. Dosing Schedule2. Two Step Approach

(Pharmacological Treatment & GETQUIT

Program ®)3. Efficacy

4. Patient Programs to save money on

prescription


Marketing Plan of PAXIL as Indicated for Smoking Cessation

• DTC Social Anxiety Disorder•This should be a first line of treatment for people who are anxious and smoke• Push Strategy•Combination Therapy•Patient Assistance Program

Increase Detail Time for PAXIL

Example of a Patient Assitance Program


Summary of Key Events in SSRI Marketplace1960’s 1980 1987 1999

•Development of Prozac begins when pharmacologist Ray Fuller joined forces with Eli Lilly to develop a “clean” drug that would work exclusively on increasing serotonin levels in the brain

•Social Anxiety Disorder entered the medical lexicon

•Social Anxiety Disorder (SAD), was a term that now included “those who struggled through situations that made them anxious”•Approximately 5 million adults were suffering from SAD

•PAXIL receives FDA approval for treatment of new indication, Social Anxiety Disorder (SAD)•May 1999, 400 million mentions of Social Anxiety Disorder (SAD) by nation and local media; end of the year, more than 1 billion mentions

Medical Definition

Guidelines/Vernacular

Lexicon StatusNew Indication,

New Communicatio

n


In Order to Treat it, You Must Understand it First:

Medical Guidelines for Smoking Cessation

•Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. Effective treatments exists, however, that can significantly increase rates of long-term abstinence.

•Individual, group, and telephone counseling are effective, and their effectiveness increases with treatment intensity.

Practical counseling (problem solving/skills training)Social support

•Numerous effective medications are available for tobacco dependence, and clinicians should encourage their use by all patients attempting to quit smoking.What does this mean

for…


Other Guidelines to Consider When Treating Smoking Cessation

•Counseling and medication are effective when used by themselves for treating tobacco dependence. The combination of counseling and medication is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use both counseling and medication.

•Tobacco dependence treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders. Providing coverage for these treatments increases quit rates. Insurers and purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered benefits.-How can PAXIL distinguish itself

when pharmacotherapy is not first line treatment?-Why should people take an SSRI for smoking cessation??


Depression Category Symptoms are High in Smoking MarketTotal Current Smokers in USA

in 2008

18 - 44 yrs old 45 - 64 yrs old65 - 74 yrs old ≥ 75 yrs

36%

35%

20%9%

20 - 39 40 - 54 ≥ 550%

10%20%30%40%50%60%70%

DepressionNo Depression

Depression vs. No Depression Before Smoking Ces-sation in ‘05-’08

% Adult smokers trying to quit in 2010

18 - 24 yrs old 25 - 44 yrs old45 - 64 yrs old ≥ 65 yrs old

30%

27%22%

21%

20 - 39 40 - 54 ≥ 550%

10%20%30%40%50%60%70%80%

Depression vs. No Depression After Ever Quit Smoking in ‘05-’08

Front – line TherapyPharmacotherapy (Bupropion SR vs.

Nicotin Medicaition)Counseling Therapy

2nd LinePharmacotherapy

(Clonidine -Catapres, Nortriptyline)

Counseling Therapy

Willing Smokers

Front – Line TherapyPharmacotherapy

(Bupropion SR vs. Nicotin Medication)

PCP & Other Driven

Substance Abuse Specialists

Unwilling Smokers

Referral Relapsed Smokers

PAXIL


Do more, feel better, live longer Questionnaire:

Paroxetine (Paxil) is a compound molecule with a broad array of indications designed to help those with debilitating mental diseases. Several current indications include: depression, anxiety, OCD, and PTSD. New research at the Department of Psychiatry and Behavioral Sciences of Stanford University is investigating the use of antidepressants in the treatment of smoking cessation.

Directions: Please respond to the following questions to the best of your knowledge and as truthfully as possible.

I. Screener

1. Are you a male or female? Male 01Female 02

2. How old were you when you first tried smoking?

Less than 13 years old 01 (Continue)Between 13-19 years old 02 (Continue)Between 20-35 years old 03 (Continue)Between 36-51 years old 04 (Continue)Between 51-64 years old 05 (Continue)Older than 64 years old 06 (Continue)Don’t Know 97 (Terminate)Refused 98 (Terminate)

3. How many packs a day do you smoke?

<1 pack 011-2 packs 023-4 packs 03>4 packs 04

II. Smoking History

4. Were you given your first cigarette from a peer?

Yes 01No 02


5. Is there a family history of smoking?

Yes 01 No 02

6. Does anyone else in your household smoke?

Yes 01 (Continue) No 02 (Skip to Question 11)

7. If Yes, Please indicate which household member currently smokes.

Mother 03Father 04Brother 05Sister 06Grandmother 07Grandfather 08Roommate 09Other 10

III. Personal Attitudes

8. What do you enjoy about smoking?

9. What do you not enjoy about smoking?


10. Ho w many people do you know smoke when they are anxious? (Example: Before a test, presentation, review meeting with their boss, etc.)

Please respond on a Scale of 1-5 with 1= nobody and 5 = many, almost all my friends

1 012 023 034 045 05

11. What emotions do you feel when you are smoking?

12. Do you believe smoke addiction to be a mental disease? Please respond on a scale from 1-5 with 1 being not at all and 5 being 100%

1 012 023 034 045 05

IV. Smoking Cessation

13. Do you surround yourself with others who are less inclined to quit smoking? Yes 01 No 02

14. How many people do you know seek help for smoking cessation?

Please respond on a scale from 1-5 with 1 = nobody and 5 = most of my friends are in search

1 012 023 034 045 05

Do more, feel better, live longer15. Have you ever tried to quit smoking?

Yes 01 No 02

If Yes, why and how many times?

<1 011-2 022-3 03>3 04

16. What is the hardest thing about trying to quit smoking?

17. Have you talked to a doctor about the possibility of quitting smoking or resources available to help you become smoke free?

Yes 01 No 02

If Yes, What did the doctor recommend?

Addiction therapy group 01 OTC patch 02Prescription medication 03Alternative therapy like yoga 04Exercise 05Did not recommend anything specific 06

18. If a nonconventional method for smoking cessation was available would you being willing to try it?

Yes 01No 02


19. If a once-daily drug therapy was able to improve smoking cessation, would you be inclined to ask your doctor for more information?

Yes 01No 02Maybe 03Not Sure 04

20. Are you aware of the smoking cessation benefits provided by antidepressant/anti anxiety medications like SSRIs?

Yes 01No 02

21. Would you be inclined to seek antidepressant therapy for smoking cessation if treatment was safe and efficacious?

Yes 01No 02Not Sure 03

If No, please elaborate:

22. If a pharmaceutical option for smoke cessation was available, which age group would be the most receptive to its use in their treatment of smoke cessation?

Less than 13 years old (with parental consent) 01Between 13-19 years old (with parental consent) 02Between 20-35 years old 03Between 36-51 years old 04Between 51-64 years old 05Older than 64 years old 06


V. ATTITUDE OF KEY OPINION LEADERS ABOUT USING PAXIL AS A FRONT LINE NON-NICOTINE MEDICATION FOR SMOKING CESSATION TREATMENT:

Q1. What is your habit of first line therapy when patients are being treated for smoking cessation?

Bupropion SR 01Nicotine gum 02Nicotine inhaler 03Nicotine lozenge 04Nicotine nasal spray 05Nicotine patch 06Varenicline 07Others 08

Q2. In what level you would evaluate you patients’ satisfaction with their first therapy?

Completely satisfied 01Somehow satisfied 02Not satisfied 03

Q3. Have you ever had any patient who failed drug therapy?

Yes 01 (Go to Q4)No 02 (Go to Q6)

Q4. What are your options if your patients failed on their prescribed treatment(s)?

Q5. How likely do you feel comfortable adding SSRI antidepressant drugs on your patients’ treatments if they failed on the previous treatment?

Completely comfortable 01Somehow comfortable 02Not comfortable at all 03


Q6. Have your patients ever had symptoms of anxiety when they are smoking?

Yes 01No 02

Q7. How likely you think adding on SSRIs would contribute a significant difference to your patients’ success on smoking cessation who already have symptoms of anxiety?

Completely difference 01Somehow difference 02No difference at all 03

Q8. Have your patients ever asked you to add other medications to their current treatment?Yes 01 If yes, what is it?________________________________________________No 02

Q9. Have you ever heard or studied any information related to SSRIs drugs which could benefit your patients on smoking cessation?

Yes 01No 02


Recommendations for How to Analyze Data from Questionnaire

• Two questions that we cross tabbed were question 5 (Is there a family history of smoking?) and question 6 ( Does anyone else in your household smoke?).

• Another two questions that we cross tabbed are question 17 (Have you talked to a doctor about the possibility of quitting smoking or resources available to help you become smoke free? ) and question 18 (If a nonconventional method for smoking cessation was available would you being willing to try it? )


Marketing Budget

$200,000

Research Group: 800 psychs with 5 patients=40,00040,000 X 10 X $20 (incentive) = $120,000Data Scrub=$30,000 $150,000Outside Research Company Fee= $10,000Outside Research Company Fee (IMS and NDTI)=$10,000Detailing=$30,000

Approximate Total $200,000

Paxil: New Indication, New Patients to Help

Education

Transcript of Paxil: New Indication, New Patients to Help