Positioning DETROL Creating a Disease Neil Wolf Group
- Slides: 52
Positioning DETROL (Creating a Disease) Neil Wolf Group Vice President, PHARMACIA Presented to PMRG October 7, 2002 1
Detrol Commercial 2
Positioning DETROL (Creating a Disease) Neil Wolf Group Vice President, PHARMACIA Presented to PMRG October 7, 2002 3
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Pharmacia & Upjohn The Situation in 1995 u A Merger without integration • Farm. Italia • Pharmacia • Upjohn u A strong “tail” • Xanax • Medrol u Successful niche marketer • Xalatan • Genotropin • Camptosar u No major presence in PCP/mass markets. 6
Pharmacia & Upjohn The Situation in 1997 u New Senior Management • Fred Hassan, CEO • Carrie Cox, EVP, Pres. Global Prescription Business • GLT (Global Leadership Team) u The “New” P&U • • Centralize Develop new processes (global) Focus on key countries and key brands Strengthen “specialty” businesses while growing Primary Care presence (critical mass) u DETROL identified as first, new, global, mass market opportunity 7
Detrol “Detrusitol” Status Product Profile • Muscarinic receptor antagonist • >70% efficacy (= oxybutinin) • Dry mouth = 23% (>70% for oxybutinin) 8
Detrol “Detrusitol” Status Product Profile • Muscarinic receptor antagonist Initial Launch Plan • “Urge incontinence” • Urologist disease • >70% efficacy (= oxybutinin) • Urologist launch only • Dry mouth = 23% (>70% for oxybutinin) 9
Market Dynamics u Small, generic market • $40 million in US • $29 million in oxybutinin (off patent) 10
Market Dynamics u Small, generic market • $40 million in US ($360 million WW) • $XX million in oxybutinin (off patent) u Prevalence 5 – 15%, skewed toward age 65+ u Large, under-diagnosed patient population • 10 - 33 million sufferers in US u Significantly under-treated condition • <20% treated with pharmacotherapy • Embarrassment • “Normal” consequence of aging • Coping mechanisms 11
Coping Mechanisms u. Toilet Mapping u. Defensive Voiding 12
Objective: Broaden and Own the Understanding of the Market • Clinical • Epidemiologic • Psychometric • Economic 13
Objective: Broaden and Own the Understanding of the Market u Clinical u Epidemiologic u COMMERCIAL OPPORTUNITY u Pyschometric u P&U CREDIBILITY u Economic 14
Converting a Niche Product into a Mass Market Opportunity u Increase the diagnosis and treatment of urge incontinence u Expand the appropriate patient population (beyond urge incontinence) 15
Converting a Niche Product into a Mass Market Opportunity u Increase the diagnosis and treatment of urge incontinence • PCP’s: Pads and/or referral to specialist • Differential diagnosis required PVR (Post Void Residual Examination) 16
Converting a Niche Product into a Mass Market Opportunity PVR Validated Questionnaire 17
Converting a Niche Product into a Mass Market Opportunity u Expand the appropriate patient population Urge Incontinence Overactive Bladder 18
Urge Incontinence Market US Urge Incontinence 12 million Sufferers 19
Overactive Bladder US Urge Incontinence 12 million sufferers Urgency 21 million sufferers Frequency 64% of patients suffer from “dry” OAB is 2. 7 -fold larger opportunity than urge incontinence 20
OAB Definitions u Frequency: urination 9 or more times within 24 hours u Urgency: strong, often sudden urge to urinate u Urge incontinence: involuntary contractions of the detrusor muscle that result in the loss of urine 21
Critical Success Factors u Establish OAB as a serious medical condition with profound negative impact on people’s quality of life… among physicians, consumers, payers and regulatory authorities u Establish Detrol as therapy of choice for OAB u Educate PCPs (including OBGs) how to screen for, diagnose and treat OAB u Drive potential patients to physician offices by using DTC and PR with symptom recognition 22
Detrol Message u. Why should I care? u. Why should I believe? 23
Detrol Message u. Why should I care? • OAB affects millions of patients • Significant impact on quality of life • OAB is a medical condition (not just aging) • Detrol can help 24
Detrol Message u. Why should I believe? • >70% efficacy • <23% dry mouth • Highly selective for bladder over salivary glands • Documented improvement in QOL 25
Detrol Strategic Imperatives CONVERSION Convert Pharmacological Therapy GROWTH PCPs “own” OAB EXPANSION Patients identify with symptoms and seek treatment 26
Detrol Strategies u Conversion • • Identify and target key prescribers and influencers Demonstrate Detrol superiority Differentiation through bladder selectivity Achieve access by payors 27
Detrol Strategies u. Conversion • • Identify and target key prescribers and influencers Demonstrate Detrol superiority Differentiation through bladder selectivity Achieve access by payors u. Growth • Establish OAB as a legitimate, treatable medical condition that should be treated • Educate PCPs on diagnosis and treatment of OAB • Remove barriers to prescribing 28
Detrol Strategies u Conversion • • Identify and target key prescribers and influencers Demonstrate Detrol superiority Differentiation through bladder selectivity Achieve access by payors u Growth • • • Establish OAB as a legitimate, treatable medical condition that should be treated Educate PCPs on diagnosis and treatment of OAB Remove barriers to prescribing u Expansion • • Provide information on self-identification to OAB sufferers Encourage PCPs to screen all appropriate patients Establish that OAB is not normal, at any age, and is treatable Encourage patients to remain on therapy 29
Creating OAB KOL’s Regulators Prescribers OAB Sufferers Media Payors 30
Creating OAB KOLs u Advisory boards, consultant meetings u Significant Phase IV activity u ICS definition of OAB changed dramatically and rapidly 31
Changing the Playing Field u 1 st International Consultation on Incontinence (ICI); 1998 • Overactive detrusor function is characterized by involuntary detrusor contractions during the filing phase………. • The unstable detrusor is one that is shown objectively to contract, spontaneously or on provocation, during the filing phase while the patient is attempting to inhibit micturition. • Note: There has been a move to change the definitions referable to the overactive detrusor and replace it with "the overactive bladder". Sufferers from incontinence better understand this term than either the "overactive detrusor" or the "unstable bladder". 32
Changing the Playing Field u Overactive Bladder Consensus Conference; July 1999 • "OAB is a medical condition referring to the symptoms of frequency and urgency, with or without urge incontinence, when appearing in the absence of local pathologic or metabolic factors that would account for these symptoms. " 33
Creating OAB Regulators u Ditropan Indication (1998 PDR): • Ditropan is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder 34
Creating OAB Regulators u Ditropan Indication (1998 PDR): • Ditropan is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder u Detrol Indication (from PI): • DETROL Tablets are indicated for the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence. 35
Creating OAB Prescribers u Create an environment where PCPs “own” OAB • Serious medical condition, not just a consequence of aging • Easy to screen, diagnose and treat 36
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OAB Screen, Diagnose, Treat u Do you go to the bathroom so often at night that it interrupts your sleep 2 or more times? u Do you go to the bathroom so often that it interferes with the things you do (often more than 8 times in 24 hours)? u Do you always have to know where the bathroom is because of frequent, strong, sudden urges to urinate? u Do you sometimes not make it to the bathroom in time? u Do you wear pads to protect your clothes from wetting? 38
Creating OAB Payors u Establish OAB as a serious medical condition, not just a “lifestyle” disorder • • Skin and soft tissue infection Falls and fractures UTIs Significant co-morbidity with depression and sleep disorders u Establish clinical superiority of Detrol over oxybutinin u Greater than 90% of managed lives have unrestricted access to Detrol 39
Creating OAB Media
Launch Sequencing u KOL Development- ’ 96 to present u Approval- December ’ 97 u OAB pre-launch rep promotion- Jan ‘ 98 u Official launch of Detrol- March ’ 98 u DTC launch- January ‘ 99 41
Summary u Differentiation from oxybutinin u Simplify Dx and Tx u Broaden disease definition 42
Differentiate from oxybutinin $40 $20 M 50% MS Price Premium (5 x) $100 M 43
Differentiate from oxybutinin $40 $20 M 50% MS Price Premium (5 x) $100 M Patients Treated 20% -> 50% $250 M Simplify Dx and Tx 44
Differentiate from oxybutinin $40 $20 M 50% MS Price Premium (5 x) $675 M OAB vs UI (2. 7 X) $100 M Patients Treated 20% -> 50% $250 M Simplify Dx and Tx Broaden Disease Definition 45
Results! u 1997 • Mkt NRxs = 1. 5 M u 2001 • Mkt NRxs = 4. 6 M 46
Results! u 1997 u 2001 • Mkt NRxs = 1. 5 M • Mkt NRxs = 4. 6 M • Mkt TRx’s = 3. 6 M • Mkt TRx’s =12. 7 M 47
Results! u 1997 u 2001 • Mkt NRxs = 1. 5 M • Mkt NRxs = 4. 6 M • Mkt TRx’s = 3. 6 M • Mkt TRx’s =12. 7 M • Mkt $ = $40. 2 M • Mkt $ = $806. 9 M 48
Results! u 1997 u 2001 • Mkt NRxs = 1. 5 M • Mkt NRxs = 4. 6 M • Mkt TRx’s = 3. 6 M • Mkt TRx’s =12. 7 M • Mkt $ = $40. 2 M • Mkt $ = $806. 9 M • Detrol TRX MS = 0% • Detrol TRX MS = 52% 49
Results! u 1997 u 2001 • Mkt NRxs = 1. 5 M • Mkt NRxs = 4. 6 M • Mkt TRx’s = 3. 6 M • Mkt TRx’s =12. 7 M • Mkt $ = $40. 2 M • Mkt $ = $806. 9 M • Detrol TRX MS = 0% • Detrol TRX MS = 52% • Detrol Sales= $0 • Detrol Sales= $400 M 50
Results! u 1997 u 2001 • Mkt NRxs = 1. 5 M • Mkt NRxs = 4. 6 M • Mkt TRx’s = 3. 6 M • Mkt TRx’s =12. 7 M • Mkt $ = $40. 2 M • Mkt $ = $806. 9 M • Detrol TRX MS = 0% • Detrol TRX MS = 52% • Detrol Sales= $0 • Detrol Sales= $400 M Estimated 2002 >$600 M 51
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