Tobacco Documents Online

NICOTINE PATCH OVERVIEW eoi4svszoz

CURRENT PERFORMANCE • Nicotine patch sales have exceeded initial expectations. 1992 estimated sales $600 - $800 million with some predicting results close to $880 million. 1993 figures to be $1 billion. • Strong demand fueled in part by heavy ad spending featuring TV and print. Magazine only spending was $18.5 million for category with about $3-$5 million for TV in January - March 1992. • Patch orders outstripping current capacity prompting plant expansion, new machine installation. • Profit margins estimated at 15% after taxes - roughly in line with cigarette industry. • Patch treatment per quitter is approximately $350.00. tdT4GVSZOz

COMpETITION • Habitrol • Ciba Geigy • 60% SOM * FDA approval 9/27/91 • Nicoderm • Alza/Marion Merrel Dow • 27% SOM • FDA approval 9/18/91 • Prostep • Elan/American Cyanimide • 13% SOM • FDA approval 1/28/92 • Nicotrol • Kabi Pharmacia/Warner Lambert/ Cygnos Therapeutic • Not in market SUTL6VSZOZ

PATCH EFFECTIVENESS • Consumer endorsement high with 88% who would recommend to a friend. • Initial clinical results indicate that the nicotine patch was somewhat more effective against placebos. Success rates for nicotine patch 17%-36% vs placebos at 4%-26% in impacting smoking abstinence. • Some sort of behavior modification was administered during the clinical tests. Without some degree of psychological therapy, many experts warn that the nicotine patch is powerless. • Nicotine gum achieved comparable results vis a vis placebos. Yet, treatment is often demanding. • Up to 30 sticks/day • Very gradual dose reduction • Required to keep product between cheek and gum 9nT46tszoz

40 35 c 25 J W Z_ 15 ~ 0 U 10 z - D.- I- o Cigarette' * 2 mg nicotine gums 0 2 I I I 4 6 8 TIME (min) L I0 12 W,

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185z 165 CigarE tte Plnsma nicotine ( nrnof/1) 145- y 125- 105~ 85~ . 65' 45-1 , 0 }0 . n" 2C 30 40 .50 f 0 T i:. e ( rnin ) NNS t Cigarette Nicotne gum l Avcral,e plasma nicotine conccntrationa of three suEyects after smokinr-a - ci~arcttc, takins~. nasal nicotinc solution (NNS), an.d chcw-ing nicotine gum. i)oscs of nicotine were 2 mg for nasaI nicotine solution and nicotine Fum ancl zvcris~cd 1•97 n:g (sce tcxt) for the cigarettc. Convcrsiorr:.. St :a trocliriarrnl ur.its--tiirntinc : I ntnal/1.;; U• 16 nglml.

PATCH CLINICAL RESULTS Post Treatment Behavioral Objectively Patch Brand Duration % Abstain Therapy Validated Patch Placebo Habitrol 3 months 36 23 Yes No Nicoderm 6 months 31 8 Yes No Nicotrol* 1 year 17 4 Yes Yes Prostep *16 hour patch 1 year 26 26 Yes Yes ntZLGtSZOz

POLACRILEX (NICOTINE GUM) CLINICAL RESULTS Post treatment Objectively Dose Tar et Duration % Abstain Validated Gum Placebo 2mg Low nicotine dependent 1 year 40 24 Yes 4mg High nicotine dependent 1 year 44 12 Yes t IY46bSZOz

METHOD USED TO QUIT SMOKING PAST 3 MONTH QUITTERS Stopped All At Once Nicotine Patch Stopped Gradually Nicotine Gum Stopped Smoking Class Hypnosis SOURCE: Smoker Tracking Study 85 ® Jan/Feb , April ~ May z TzLsVszoz