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RGA6201 Final Project– Group #2 Chantix and it’s Marketing Overview Members: Devang Barot Phani Venkata Sekhar Puppala Irina Fedorov Sunder Singh Bob Gottumukkala Manasa Survi Reema Bhatt Shruti Nayak
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Chantix and its marketing overview

Dec 13, 2014

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Healthcare

Manasa Survi

Chantix and its marketing overview
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Page 1: Chantix and its marketing overview

RGA6201 Final Project– Group #2Chantix and it’s Marketing Overview

Members:

• Devang Barot• Phani Venkata Sekhar Puppala• Irina Fedorov• Sunder Singh Bob Gottumukkala • Manasa Survi• Reema Bhatt• Shruti Nayak

Page 2: Chantix and its marketing overview

Importance to Practice:

1.3 billion smokers world wide20.9% in the United States

Obvious Health RisksLeading cause of preventable deathCardiovascular Disease

70% higher chance of dying from coronary artery disease

Lung DiseaseVery difficult to quit

Up to 60% relapse within first yearDue to addictive nature of nicotine

Page 3: Chantix and its marketing overview

DISSCUSS THE PRODUCT:

Chantix (Varenicline)Non-nicotine replacement therapyReceived FDA approval in 2006Discovered while attempting to develop a

transdermal patch for Alzheimer's DiseaseWas shown to have smoking cessation

properties, but was dismissed until Pfizer picked up on the research.

Page 4: Chantix and its marketing overview

Pharmacology of Varenicline

MOA: partial nicotinic acetylcholine receptor agonist, binding specifically to the alpha 1 beta 2 receptor.Stimulates dopamine release-

pleasurable effects of nicotine, decrease in withdrawal.

Declined sense of satisfaction with smoking.

Oral administration, essentially total bioavailability.

Half life of 17-30 hours.

Page 5: Chantix and its marketing overview

Dosing:

Days 1-3: 0.5 mg once dailyDays 4-7: 0.5 mg twice dailyWeek 2-12: 1 mg twice daily

Patient can receive an additional 12 weeks of treatment if smoking cessation not obtained or danger of relapse.

Determined using Phase III trialsStudies show that as dosage increased, quit

rates increased.37.3% quit rate with 1 mg once daily, and

48.0% quit rate with 1 mg twice daily compared to placebo’s 17.1%.

Page 6: Chantix and its marketing overview

REGULATORY PITFALLS OF CHANTIX:

• Side effects related to Chantix:

• Side effects included on the package insert/label/medication guide are:

1. Neuropsychiatric and Suicidal Symptoms.2. Angioedema and Hypersensitivity Reactions 3. Cardio Vascular Events 4. Nausea and Vomiting5. Accidental injuries

• Doctors do not prescribe Chantix and sometimes patients stop taking Chantix following these side effects.

• Over 2,300 complaints pending against Pfizer.

Page 7: Chantix and its marketing overview

REGULATORY PITFALLS OF CHANTIX: CONTINUED…

• Clinical Trials

• Some studies fail/get terminated/withdrawn. Chantix has also faced similar dark phase.

• Study at MGH: 410 subjects enrolled. From July 2010:

Primary endpoint: 4-week continuous abstinence.Result: Dose was increased from 0.5 mg once a day to 1mg twice a day, severe adverse events observed in 66% of the subjects.By the end of October 2010, out of 410, 219 subjects had already withdrawn from the study and the remaining subjects were not true and genuine towards the treatment.

• Hence considered as one of the major Regulatory pitfall for Chantix.

Page 8: Chantix and its marketing overview

REGULATORY PITFALLS OF CHANTIX: CONTINUED…

• This is a Black Box warning on Chantix’s labeling information. WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

See full prescribing information for complete boxed warning.

• Serious neuropsychiatric events have been reported in patients taking CHANTIX. (5.1 and 6.2)

• Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation,

hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops

suicidal ideation or suicidal behavior while taking CHANTIX or shortly after discontinuing CHANTIX. (5.1 and 6.2)

• Weigh the risks of CHANTIX against benefits of its use. CHANTIX has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo.

The health benefits of quitting smoking are immediate and substantial. (5.1 and 6.2)

• In July, 2009, Pfizer added Black Box Warning to

Chantix’s prescribing information.

• Due to Chantix’s conformed risks and side effects

and also several patient review.

Page 9: Chantix and its marketing overview

• Reasons for the Black Box Warning: • Serious ‘Neuropsychiatric Events’. • Depression, suicidal ideation, suicide attempt, and

completed suicide have been noted with the patients taking Chantix.

• Changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX.

•Steps to be taken by Pfizer to overcome these Regulatory Pitfalls:

• Find a collateral support and publish the positive feedback it received for Chantix by using patient groups, social activists, thought leaders.

• By showing efficacy and safety results of the Chantix in the patients of the cardiovascular disease and COPD who can be greatly benefited by quitting the smoking.

REGULATORY PITFALLS OF CHANTIX: CONTINUED…

Page 10: Chantix and its marketing overview

FORMULATING MARKETING STRATEGY FOR CHANTIX

• Pfizer launched a program “Your road to quit smoking” that includes “GETQUIT” plan.

• Slow and steady wins the race is the caption for the Chantix TV DTC (direct to consumer) ad.

• The GETQUIT support plan helps patients with:

a. Preparing to quit by following a Step-by-step guide.

b. Patient website designed with easy to use tools using

progress trackers.

c. Support for up to a full year, and advice to help you learn

to stay quit.

d. A toll free support hotline to speak with a GETQUIT coach.

e. Doctor for support during the quit.

More recently, Pfizer updated smoking cessation counseling card.

Page 11: Chantix and its marketing overview

• Doctor discussion guide for a better interaction between the

patients and the doctor.

• Pfizer’s “patient assistance programs” are as follows:

Connection to care

Pfizer Pfriends

First Resource

Sharing the care

• Other sources of prescription help are:

Medicare Prescription Drug Coverage Part D

Partnership for Prescription assistance (PPA)

Rx outreach

FORMULATING MARKETING STRATEGY FOR CHANTIX: CONTINUED…

Page 12: Chantix and its marketing overview

• GETQUIT is to be used with the recommended 12 week therapy of CHANTIX.

FORMULATING MARKETING STRATEGY FOR CHANTIX: CONTINUED….

Page 13: Chantix and its marketing overview

CHALLENGES FACED BY CHANTIX

• Chantix side effects have led thousands of patients to file lawsuits against Pfizer.

• Allegations of: depressions, suicidal thoughts and severe mood swings.

• In 2008 FDA issued an alert regarding behavior changes and aggression related to Chantix use.

• During a single 18-month period, more than 300 reports of suicidal thoughts and depression were reported to the FDA by Chantix users.

In some cases, individuals have successfully taken their own lives after using the medication, resulting in survivors filing Chantix lawsuits to pursue compensation for their losses.

• The latest product liability suit against Pfizer, makers of anti-smoking drug Chantix, has joined thousands of other cases in multidistrict litigation (MDL) currently underway in the US District Court for the Northern District of Alabama.

Page 14: Chantix and its marketing overview

CHALLENGES FACED BY CHANTIX: CONTINUED…

• Plaintiff Laurie Lee Dorman from Minnesota filed lawsuit against Pfizer in 2013. She suffered severe depression and severe suicidal

thought as a result of taking the drug. Dorman seeks damages for negligence, design defect, failure to warn, breach of express and implied warranties, and fraudulent misrepresentation.

• In October 2012, a confidential settlement was reached between Pfizer and plaintiff Judy Ann Whitely, the widow of a man who committed suicide in November 2007 shortly after he began taking Chantix. The thousands of plaintiffs whose cases are currently pending hope to engage in similar Chantix lawsuit settlement negotiations, or to receive jury awards at trial. THANK YOU

Page 15: Chantix and its marketing overview

References:

1. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021928_s000_Chantix_ChemR.pdf

2. http://www.chantix.com/docs/Day-1_CigaretteFreeZone.pdf3. http://www.pfizerpro.com/hcp/chantix/resource-center.4. http://chantixlawsuit-info.com/2011/04/chantix-side-effects-tv-

ads-commercials/5. http://druginserts.com/lib/rx/meds/chantix-4/6. http://clinicaltrials.gov/ct2/show/NCT00691483?

term=chantix&rank=1127. http://labeling.pfizer.com/ShowLabeling.aspx?id=5578. http://www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/ucm259469.htm9. http://chantixlawsuit-info.com/2013/01/chantix-plaintiff-alleges-

crying-spells-suicidal-thoughts/10. http://www.chantix.com/docs/Day-3_pdf_QuitStrategies.pdf11. http://www.pfizerpro.com/resources/minisites/chantix/docs/

Eff_Bro_for_PFP.pdf