Pharmaceutical Therapeutic Categories Outlook
`
`October 2003
`
`
`
`
`
`Please refer to the back of this report for important disclosures.
`Kenneth C. Cacciatore
`Ian C. Sanderson
`Stephen M. Scala, CFA
`(212) 278-4519
`(617) 946-3922
`(617) 946-3923
`ken.cacciatore@sgcowen.com
`ian.sanderson@sgcowen.com
`steve.scala@sgcowen.com
`
`Jean B. Perreault
`(617) 946-3967
`jean.perreault@sgcowen.com
`
`Seamus Fernandez
`(617) 946-3893
`seamus.fernandez@sgcowen.com
`
`Eric Schmidt, Ph.D.
`(212) 278-4515
`eric.schmidt@sgcowen.com
`
`Phil Nadeau, Ph.D.
`(212) 278-4513
`phil.nadeau@sgcowen.com
`
`Yaron Werber, M.D.
`(212) 278-4504
`yaron.werber@sgcowen.com
`
`Ravi Mehrotra
`(44) 20-7762-5540
`ravi.mehrotra@sgcib.com
`
`Andrew Sinclair
`(44) 20-7762-5542
`andrew.sinclair@sgcib.com
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1058 - Page 1
`
`

`
`ESTIMATED U.S. MARKET FOR URINARY INCONTINENCE (STRESS + URGE) DRUGS*
`2002
`2003E
`2004E
`2005E
`2006E
`2007E
`CGR
`Comment
`
`U.S. Population/Prescriptions (000's)
`Overactive Bladder Sufferers
`% Incontinence Pts Seeking Treatment
` Incontinence Pts Seeking Treatment
`Drug Therapy Market Share
`Incontinence Pts Placed On Drug Tx
`Drug Therapy Retention Factor
`Incontinence Pts Compliant With Tx
`Number of Scrips Filled/Year
` % Growth
`
`19,044
`37%
`7,046
`42%
`2,931
`48%
`1,407
`15,046
`+9%
`
`26%
`3,890
`$2.25
`$305
`
`34%
`5,096
`$2.20
`$395
`
`Detrol LA (PFE) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Detrol LA Sales ($MM)
`Duloxetine (LLY) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Duloxetine Sales ($MM)
`Ditropan XL (JNJ/AZA) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Ditropan XL Sales ($MM)
`Oxytrol (WPI) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Oxytrol Sales ($MM)
`Enablex (NVS) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Enablex Sales ($MM)
`Trospium (IDEV) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Trospium Sales ($MM)
`Vesicare (YM-905) Market Share
` Prescriptions (000's)
` Price Therapy/Day
`Vesicare Sales ($MM)
`15%
`Detrol (PFE) Market Share
`2,269
` Prescriptions (000's)
`$2.31
` Price Therapy/Day
`$185
`Detrol Sales ($MM)
`17%
`Generic Oxybutynin Market Share
`2,542
` Prescriptions (000's)
`$33
`Oxybutynin Generics Sales ($MM)
`$19
`Other Therapies Sales ($MM)
`$937
`U.S. Incontinence Drug Sales ($MM)
`+25%
` % Growth
`Source: SG Cowen estimates, IMS Monthly Prescriptions.
`* Patient population and scrips in 000's; sales in $MM.
`
`19,634
`38%
`7,366
`44%
`3,209
`47%
`1,502
`15,817
`+5%
`
`44%
`7,022
`$2.40
`$600
`
`20,262
`38%
`7,695
`46%
`3,548
`46%
`1,645
`17,324
`+10%
`
`46%
`7,978
`$2.50
`$710
`
`24%
`3,810
`$2.40
`$320
`2%
`392
`$2.15
`$27
`
`7%
`1,180
`$2.40
`$100
`14%
`2,161
`$28
`$18
`$1,093
`+17%
`
`22%
`3,818
`$2.50
`$335
`6%
`1,094
`$2.25
`$80
`2%
`294
`$2.50
`$25
`1%
`125
`
`$2.50
`$10
`1%
`125
`$2.50
`$10
`5%
`907
`$2.50
`$80
`10%
`1,700
`$22
`$19
`$1,291
`+18%
`
`20,890
`41%
`8,565
`48%
`4,090
`49%
`2,010
`21,019
`+21%
`
`43%
`9,117
`$2.55
`$830
`10%
`2,094
`
`$2.55
`$185
`17%
`3,631
`$2.55
`$325
`8%
`1,612
`$2.35
`$125
`3%
`560
`$2.55
`$50
`3%
`577
`
`$2.55
`$50
`3%
`577
`$2.55
`$50
`3%
`654
`$2.60
`$60
`7%
`1,400
`$18
`$12
`$1,705
`+32%
`
`21,517
`43%
`9,347
`51%
`4,734
`49%
`2,317
`24,085
`+15%
`
`42%
`10,019
`$2.60
`$930
`16%
`3,895
`
`$2.60
`$365
`14%
`3,452
`$2.60
`$315
`8%
`1,894
`$2.40
`$150
`4%
`879
`$2.60
`$80
`4%
`879
`
`$2.60
`$80
`4%
`879
`$2.60
`$80
`2%
`405
`$2.80
`$40
`5%
`1,270
`$17
`$13
`$2,070
`+21%
`
`22,163
`46%
`10,128
`53%
`5,335
`49%
`2,631
`27,323
`+13%
`
`40%
`10,887
`$2.65
`$1,030
`20%
`5,354
`
`$2.65
`$510
`12%
`3,333
`$2.65
`$310
`8%
`2,210
`$2.40
`$175
`4%
`1,078
`$2.65
`$100
`4%
`
`1,078
`$2.65
`$100
`4%
`1,078
`$2.65
`$100
`1%
`405
`$2.80
`$40
`4%
`1,225
`$16
`$14
`$2,395
`+16%
`
`+8%
`
`+13%
`
`+3% - 18MM+ Americans with overactive bladder
`- Patients seeking treatment increase with better
` diagnosis, availability of newer treatments
`- Drug therapy market share expected to climb
` significantly with introduction of Duloxetine
`- Newer products with fewer side effects and longer
` duration and new products for stress incontinence
`- Newer products for urge incontinence and
` 2005 introduction of Duloxetine for SUI
`
`+13%
`+13%
`
`- Once-daily LA launched 1/01
`- Improved side-effect profile compared to Detrol
`
`- Eli Lilly expected to launch in Q1:2005
`- Stress urinary incontinence; first in class product
`
`-
`- New treatments with lower side effects clip
`- Launched 2/99 for overactive bladder
`
`- Oxybutynin patch; improved side-effect profile
`- Marketed by Women's Health, GP Division & CSO
`
`- Sold by Pfizer to Novartis in Q1:2003
`- NDA Q1:2003; H1:2004 launch assumed
`
`- Side-effect profile clips potential
`- NDA Filing 4/03; H2 2004E launch
` U.S. trials positive on side effects/efficacy
`
`- NDA Filing 12/02; H1 2004E launch
` GlaxoSmithKline co-marketing in U.S.
`
`- Continued conversion to LA
`
`- Price increases bolster switch to Detrol LA
`
`- Share decline with launch of new UUI therapies
`
`- Other generics (flavoxate, imipramine, etc.)
`
`- Improved treatments, better compliance
` (Market sales include generics)
`
`+21%
`
`NA
`
`+0%
`
`NA
`
`NA
`
`NA
`
`NA
`
`-26%
`
`-14%
`-6%
`+21%
`
`
`
`
`
`
`
`434
`
`Therapeutic Categories Outlook 10/2003
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1058 - Page 2
`
`

`
`ESTIMATED U.S. MARKET FOR STRESS URINARY INCONTINENCE (SUI) DRUGS*
`2002
`2003E
`2004E
`2005E
`2006E
`2007E
`CGR
`Comment
`
`+3% - 18MM+ Americans with overactive bladder
`
`+3% - Includes portion of patients with mixed UI
`
`+9%
`
`+28%
`
`+45%
`
` - Assumes Duloxetine launched Q1 2005
`
`- Newer products with proven efficacy; compliance
` remains somewhat low due to transient nausea
`
`- Availability of FDA approved products for
` treating stress incontinence
`- Launch delayed to 2005 following request
` for additional clinical toxicology studies
`
`22,163
`50%
`11,081
`44%
`4,876
`34%
`1,658
`35%
`580
`5%
`5,949 +42%
`+37%
`90%
`5,354
`+37%
`$2.65
`$510
`10%
`595
`$10
`
`U.S. Population/Prescriptions (000's)
`Overactive Bladder Sufferers
` % With Stress UI Symptoms
`Stress/Stress Predominant UI Sufferers
`% SUI Patients Seeking Treatment
`SUI Patients Seeking Treatment
`Drug Therapy Market Share
`SUI Patients Placed On Drug Tx
`Drug Therapy Retention Factor
`SUI Patients Compliant With Tx
`% SUI Patients Compliant With Tx
`Number of Scrips Filled/Year
` % Growth
`Duloxetine (LLY) Market Share
` Prescriptions (000's)
` % Growth
` Price Therapy/Day
`Duloxetine Sales ($MM)
`Other Therapies Market Share
` Prescriptions (000's)
`Other Therapies Sales ($MM)
`
`19,044 19,634 20,262 20,890 21,517
`50%
`50%
`50%
`50%
`50%
`9,522
`9,817 10,131 10,445 10,759
`33%
`33%
`33%
`38%
`41%
`3,142
`3,240
`3,343
`3,969
`4,411
`15%
`15%
`15%
`22%
`29%
`471
`486
`501
`873
`1,279
`20%
`20%
`20%
`30%
`33%
`94
`97
`100
`262
`422
`1%
`1%
`1%
`2%
`4%
`1,059
`1,091
`1,144
`2,792
`4,328
`+13%
`+3%
`+5%
`+144%
`+55%
`75%
`90%
`2,094
`3,895
`+86%
`$2.60
`$365
`10%
`433
`$10
`
`100%
`1,059
`$16
`
`100%
`1,091
`$16
`
`100%
`1,144
`$17
`
`$2.55
`$185
`25%
`698
`$10
`
`NA - U.S. sales only
`
`-20%
`-11%
`
`Total SUI Drug Sales ($MM)
` % Growth
`
`$16
`
`$16
`
`$17
`
`$195
`
`$375
`+92%
`
`$520
`+39%
`
`
`NA - New treatment category dominated by
` Duloxetine
`
`Source: SG Cowen estimates, IMS Monthly Prescriptions.
`* Patient population and scrips in 000's; sales in $MM.
`
`
`
`
`
`
`Additional Products Less Visible
`Many other drugs are in clinical development for treating urge and stress incontinence.
`Sepracor's s-oxybutynin, a single isomer formulation of oxybutynin currently in Phase III
`development, may demonstrate a lower level of side effects with similar efficacy. In June 2001,
`Sepracor initiated a twelve-week Phase III study including approximately 850 patients using a
`once-daily, sustained-release formulation of s-oxybutynin, but development has been delayed
`by the need for 2-year animal carcinogenicity studies, which should complete in late 2003. Also
`of note is Roche's Phase II clinical program for an alpha-1 agonist (R-450) for treating stress and
`mixed incontinence; however, we remain cautious on alpha-agonists due to potential cardiac
`toxicity. Although early, our physician consultants believe the next evolution in treatment likely
`will be drugs specifically targeting the afferent neuronal pathways, which desensitize the
`bladder to prevent
`incontinence episodes.
` However, agents such as Afferon/ICOS'
`resiniferatoxin (Phase II) are injected via the urethra directly into the bladder, a significant
`disadvantage to oral agents. Among currently marketed agents that inhibit afferent neuronal
`pathways, Allergan’s Botox (botulinum toxin) is being used off-label for the treatment of
`overactive bladder. Numerous physician-initiated clinical trials have shown a significant benefit
`with 100-300mg of Botox, injected directly into the bladder, to manage incontinence. However,
`given lack of reimbursement and the invasive nature of the procedure, use of Botox is likely to
`remain a last-line option for patients.
`
`
`
`443
`
`Therapeutic Categories Outlook 10/2003
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1058 - Page 3
`
`

`
`ANALYST CERTIFICATION
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`
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`
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`
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`
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`2003. All rights reserved.
`
`SG COWEN RATING DEFINITIONS
`
`Definition
`Rating
`Stock expected to outperform the S&P 500 by over 25%
`Strong Buy (1)
`Stock expected to outperform the S&P 500 by 10-25%
`Outperform (2)
`Stock expected to out/underperform the S&P 500 by +/-10%
`Market Perform (3)
`Stock expected to underperform the S&P 500 by at least 10%
`Underperform (4)
`Assumptions: Time horizon is 12 months; S&P 500 is flat over forecast period.
`
`Rating
`Strong Buy (1)
`Buy (2)
`Neutral (3)
`Underperform (4)
`
`SG COWEN RATING DEFINITIONS PRIOR TO 9/9/2002
`
`Definition
`Analyst expects the stock to outperform the market over the next 6-12 months
`Analyst expects the stock to outperform the market over the next 12-18 months
`Analyst expects the stock to perform in line with the market over the next 12 months
`Analyst expects the stock to underperform the market over the next 12 months
`
`SG COWEN RATING ALLOCATION (a)
`Pct for which Investment Banking services
`Pct of companies under
`have been provided within the past 12 months
`coverage with this rating
`Rating
`6.0%
`51.8%
`Buy (b)
`0.5%
`42.8%
`Hold (c)
`0.3%
`5.2%
`Sell (d)
`(a) As of 09/30/2003. (b) Includes "Strong Buy" and "Outperform" rated stocks as defined in SG Cowen's rating system (see
`above). (c) Corresponds to "Market Perform" as defined in SG Cowen's ratings system (see above). (d) Corresponds to
`"Underperform" as defined in SG Cowen's ratings system (see above).
`Note: "Buy," "Hold" and "Sell" are not defined SG Cowen ratings and should not be construed as investment options. Rather,
`these ratings are used illustratively to comply with NASD and NYSE regulations.
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1058 - Page 4
`
`

`
`
`
`
`
`Definition
`Rating
`Stock expected to outperform the market by at least 10%
`Buy
`Stock expected to perform in line with the market +/-10%
`Hold
`Stock expected to underperform the market by at least +/-10%
`Sell
`Assumptions: Time horizon is 3-6 months and flat market over the forecast period
`
`SG RATING DEFINITIONS
`
`To view price charts, please see:http://pricecharts.sgcowen.com/pricechart.asp or call 1-888-762-4373.
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1058 - Page 5