1 Nonprescription Drugs and Dermatologic and Ophthalmic Drugs Joint Advisory Committee Meeting Over-the-Counter Antifungal Drug Products Treatment of Tinea pedis May 6, 2004 Nonprescription Drugs and Dermatologic and Ophthalmic Drugs Joint Advisory Committee Meeting Over-the-Counter Antifungal Drug Products Treatment of Tinea pedis May 6, 2004 Schering-Plough HealthCare Products

2 Agenda Marketing HistoryMarketing History Clinical ExperienceClinical Experience Consumer ExperienceConsumer Experience Consumer ResearchConsumer Research Labeling RecommendationsLabeling Recommendations Conclusions and RecommendationsConclusions and Recommendations Schering-Plough HealthCare Products

3 Schering-Plough leader in research and marketing of Rx and over-the-counter (OTC) topical antifungals for the treatment of tinea for more than 40 years has been a leader in research and marketing of Rx and over-the-counter (OTC) topical antifungals for the treatment of tinea for more than 40 years Schering-Plough HealthCare Products

4 Antifungal Products Marketed since 1960’sMarketed since 1960’s Developed tolnaftate and clotrimazoleDeveloped tolnaftate and clotrimazole Products represent 44% of the OTC antifungal market in units soldProducts represent 44% of the OTC antifungal market in units sold Brands includeBrands include Lotrimin Ultra Cream Lotrimin AF Tinactin Aftate Dr. Scholl’s Antifungal agents includeAntifungal agents include Butenafine hydrochloride Tolnaftate Clotrimazole Miconazole nitrate Schering-Plough HealthCare Products

5 Clinical Experience Clinical trials of a variety of designs have demonstrated the safety and efficacy of these products at current dosing levelsClinical trials of a variety of designs have demonstrated the safety and efficacy of these products at current dosing levels Even though study endpoints have changed dramatically over the past four decades, significant clinical efficacy has consistently been demonstratedEven though study endpoints have changed dramatically over the past four decades, significant clinical efficacy has consistently been demonstrated Schering-Plough HealthCare Products

6 Clinical Efficacy Endpoints Complete cure endpoint definition is an unrealistic parameter of efficacy based on natural course of healingComplete cure endpoint definition is an unrealistic parameter of efficacy based on natural course of healing Effective treatment is a more appropriate descriptor of efficacy:Effective treatment is a more appropriate descriptor of efficacy: –Negative mycology (negative culture and KOH) –Minimal erythema and scaling Schering-Plough HealthCare Products

7 All antifungal ingredients had successful Rx clinical experienceAll antifungal ingredients had successful Rx clinical experience More than 230,000,000 units sold OTC since 1991More than 230,000,000 units sold OTC since 1991 Extensive patient and consumer experience confirms that these products are very effectiveExtensive patient and consumer experience confirms that these products are very effective Complaints regarding lack of efficacy are extremely low: 2 per million units sold over past 5 yearsComplaints regarding lack of efficacy are extremely low: 2 per million units sold over past 5 years Consumer experience confirms satisfaction with current OTC productsConsumer experience confirms satisfaction with current OTC products Consumer Experience Schering-Plough HealthCare Products

8 Consumer Research Data Consumer Tracking Studies conducted annually for past 10 years provide excellent view of consumer experience with condition and treatmentConsumer Tracking Studies conducted annually for past 10 years provide excellent view of consumer experience with condition and treatment Most recent study - October 2003Most recent study - October 2003 Approximately 350 consumers, yrs oldApproximately 350 consumers, yrs old Suffered from athlete’s foot in the past 12 monthsSuffered from athlete’s foot in the past 12 months 70% male, 30% female70% male, 30% female Research is conducted via an internet surveyResearch is conducted via an internet survey Schering-Plough HealthCare Products

9 Consumer Research Data Consumers purchase OTC topical antifungals driven by need for symptom reliefConsumers purchase OTC topical antifungals driven by need for symptom relief –Universally treated by consumers – 95% –~80% purchase 4-week products –~20% purchase < 4-week products Intense itching and burning are primary treatment driversIntense itching and burning are primary treatment drivers –69% rate symptoms as “very bothersome/bothersome” Schering-Plough HealthCare Products

10 Consumer Research Data Relief begins within a matter of a few days following initiation of treatmentRelief begins within a matter of a few days following initiation of treatment –Provides fast relief ~60% Consumers tend to discontinue use after relief of symptomsConsumers tend to discontinue use after relief of symptoms –Average treatment period – 7.3 days! Schering-Plough HealthCare Products

11 Consumer Research Data Shorter treatment options have not dramatically changed consumer treatment behaviorShorter treatment options have not dramatically changed consumer treatment behavior –1997 Study – 8.8 days average treatment –2003 Study – 7.3 days average treatment Only 6% report treatment of >14 daysOnly 6% report treatment of >14 days More than 50% treat 5 days or less on averageMore than 50% treat 5 days or less on average Overall consumer satisfaction with OTC antifungals is strong – 86%Overall consumer satisfaction with OTC antifungals is strong – 86% 42% report experiencing athlete’s foot less often now than 2 years ago42% report experiencing athlete’s foot less often now than 2 years ago Schering-Plough HealthCare Products

12 Consumer Research Data Conclusions Consumers are highly satisfied with performance of currently marketed OTC topical antifungalsConsumers are highly satisfied with performance of currently marketed OTC topical antifungals Consumers consistently experience fast relief of symptomsConsumers consistently experience fast relief of symptoms Therefore, most consumers do not use their product for the entire duration of the labeled treatment periodTherefore, most consumers do not use their product for the entire duration of the labeled treatment period Schering-Plough HealthCare Products

13 Recommended Enhanced Labeling Therapeutic success can be enhanced by an additional label statement under Directions to reinforce the need to use for the full treatment period:Therapeutic success can be enhanced by an additional label statement under Directions to reinforce the need to use for the full treatment period: use daily as directed for the full use daily as directed for the full treatment time, even if symptoms improve treatment time, even if symptoms improve Schering-Plough HealthCare Products

14 Complications Related to Tinea Pedis Occurrence of other infections, such as cellulitis, is extremely rareOccurrence of other infections, such as cellulitis, is extremely rare –No published literature associating cellulitis and topical antifungals –FDA reports only 13 cases of cellulitis associated with Rx and OTC topical antifungal use over the past 30 years Some cases are related to non-tinea usesSome cases are related to non-tinea uses Schering-Plough HealthCare Products

15 Recommended Enhanced Labeling Concerns of other infections can be addressed through an additional Warning statementConcerns of other infections can be addressed through an additional Warning statement Stop use and ask a doctor if there is no improvement in 14 days there is no improvement in 14 days or condition worsens or condition worsens Schering-Plough HealthCare Products

16 Conclusions and Recommendations Current products are very effective in treating tinea pedis as demonstrated by clinical trials and consumer satisfactionCurrent products are very effective in treating tinea pedis as demonstrated by clinical trials and consumer satisfaction Products are extremely safe based on extensive Rx and OTC marketing historyProducts are extremely safe based on extensive Rx and OTC marketing history Effective Treatment is the appropriate clinical endpoint to evaluate product efficacyEffective Treatment is the appropriate clinical endpoint to evaluate product efficacy Labeling should be enhanced to improve consumer compliance and treatment successLabeling should be enhanced to improve consumer compliance and treatment success Schering-Plough HealthCare Products