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 Help
Treatment 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 Budget
Q & 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.


Smoking Statistics
•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


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 Budget
Q & A


Pipeline Analysis of Smoking Cessation/Drug Dependency Therapies in
Current Market
GlaxoSmithKline Pfizer
Pipeline Analysis 2008-2010 Pipeline Analysis 2008-2010

Drug ID Disease 2008 2009 2010 •Pfizer had its smoking cessation drug Chantix
approved in 2006, making it the first
State prescription smoking cessation medicine to be
598809 Drug Phase approved in 10 years
Dependency I •By 2008, Chantix/Champix (trade name outside
of US) had lost 4% in sales and was bringing in
618334 Drug Phase Phase $846 million
dependency I I •2009: Chantix/Champix is still the leading
pharmaceutical for smoking cessation in the
468816 Smoking Phase world.
cessation II •Pfizer supports smoking cessation projects in 46
countries
In 2009, GSK stopped funding research for smoking
•Chantix was not mentioned in the 2010 Annual
cessation drugs because OTC sales were down 12%.
Report.
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.


Case Study: Chantix
Competitive Advantages and Lessons Learned
Chantix
Chemical name: Verenicline
(nicotine blocker)

Competitive advantages
1. Dosing Schedule
2. 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 Marketplace
1960’s 1980 1987 1999
•Development of Prozac •Social Anxiety Disorder •Social Anxiety Disorder •PAXIL receives FDA
begins when entered the medical (SAD), was a term that approval for treatment of
pharmacologist Ray Fuller lexicon now included “those who new indication, Social
joined forces with Eli Lilly struggled through Anxiety Disorder (SAD)
to develop a “clean” drug situations that made them •May 1999, 400 million
that would work exclusively anxious” mentions of Social
on increasing serotonin •Approximately 5 million Anxiety Disorder (SAD) by
levels in the brain adults were suffering from nation and local media;
SAD end of the year, more than
1 billion mentions

Medical Guidelines/
Definition New Indication,
Vernacular
New
Lexicon Status
Communication


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 Market
Total Current Smokers in USA % Adult smokers trying to quit
in 2008 in 2010
9% 21% 30%
20% 36%
22%
35% 27%

18 - 44 yrs old 45 - 64 yrs old 18 - 24 yrs old 25 - 44 yrs old
65 - 74 yrs old ≥ 75 yrs 45 - 64 yrs old ≥ 65 yrs old

Depression vs. No Depression After Ever
Depression vs. No Depression Before Smoking Quit Smoking in ‘05-’08
Cessation in ‘05-’08 80%
80%
60% 60%

40% 40%

20% 20%
0% 0%
Depression
20 - 39 40 - 54 ≥ 55 No Depression 20 - 39 40 - 54 ≥ 55


Front – line Therapy
Pharmacotherapy 2nd Line
Substance Abuse (Bupropion SR vs. Pharmacotherapy
Specialists Nicotin Medicaition) (Clonidine -
Counseling Therapy Catapres, Nortriptylin
e)
Counseling Therapy

Willing
Smokers
Referral Relapsed
Smokers
Unwilling
Smokers

Front – Line Therapy
PCP & Other Pharmacotherapy
Driven (Bupropion SR vs. Nicotin PAXIL
Medication)

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 01
Female 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)
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 01
1-2 packs 02
3-4 packs 03
>4 packs 04

II. Smoking History

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

Yes 01
No 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 03
Father 04
Brother 05
Sister 06
Grandmother 07
Grandfather 08
Roommate 09
Other 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 01
2 02
3 03
4 04
5 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 01
2 02
3 03
4 04
5 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 01
2 02
3 03
4 04
5 05

15. Have you ever tried to quit smoking?

Yes 01
No 02

If Yes, why and how many times?

<1 01
1-2 02
2-3 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 02
Prescription medication 03
Alternative therapy like yoga 04
Exercise 05
Did not recommend anything specific 06

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

Yes 01
No 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 01
No 02
Maybe 03
Not Sure 04

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

Yes 01
No 02

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

Yes 01
No 02
Not 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) 01
Between 13-19 years old (with parental consent) 02
Between 20-35 years old 03
Older 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 01
Nicotine gum 02
Nicotine inhaler 03
Nicotine lozenge 04
Nicotine nasal spray 05
Nicotine patch 06
Varenicline 07
Others 08

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

Completely satisfied 01
Somehow satisfied 02
Not 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 01
Somehow comfortable 02
Not comfortable at all 03


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

Yes 01
No 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 01
Somehow difference 02
No 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 01
No 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=40,000
40,000 X 10 X $20 (incentive) = $120,000
Data Scrub=$30,000 $150,000
Outside Research Company Fee= $10,000
Outside Research Company Fee (IMS and NDTI)=$10,000
Detailing=$30,000

Approximate Total $200,000

Paxil: New Indication, New Patients to Help

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