 DecisionBase PDFs --
2008
 Overview:
Urge urinary incontinence is a highly prevalent yet
significantly underdiagnosed and undertreated disease. Despite the availability
of numerous UUI therapies, dominated by anticholinergic agents, a sizeable
proportion of UUI patients remain suboptimally served by existing agents.
Agents from novel drug classes that can control bladder activity and cause
relaxation of bladder smooth muscle represent a significant unmet need. Experts
emphasize that an even greater understanding of the pathology of UUI and
overactive bladder will likely be needed for the successful launch of many new
classes. In the meantime, anticholinergic drugs continue to be the focus of
late-stage clinical development with the recent and near-term launches of a
half-dozen anticholinergic follow-on agents and new formulations.
Questions Answered in This Report:
 A drug’s performance on at least three efficacy end points,
including rate of total dryness, is important for drug approval and physician
use. What are the key primary and secondary clinical trial end points with
which new therapies are evaluated? How do urologists weight efficacy measures
and other drug attributes in their prescribing decisions for UUI?
Extended-release (ER) tolterodine (Pfizer’s Detrol
LA/Detrusitol XL) is the 2006 major-market sales leader for UUI. How will
emerging agents fare against ER tolterodine? Will emerging therapies offer
improvements in the efficacy end points and drug attributes that are most
influential in physician prescribing decisions? Which emerging therapies, if
any, are best positioned to challenge the market-leading status of ER
tolterodine?
Despite the potential launch of several emerging therapies
in the urge urinary incontinence market over the next ten years, solifenacin (Astellas
Pharma’s Vesicare) will remain the gold-standard therapy in our drug comparator
model. On what clinical attributes is solifenacin most differentiated from its
competitors? What are the weaknesses of this therapy upon which emerging
therapies can capitalize? Which emerging therapies, if any, pose the greatest
threat to solifenacin as well as the other key current therapies?
Scope:
Key drug development opportunity tested in our target
product profiles for urge urinary incontinence: A drug treatment offering a
greater reduction in the number of UUI episodes per week than extended-release
tolterodine for the treatment of urge urinary incontinence.
Physicians surveyed for this study: 60 U.S. urologists.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Extended-release tolterodine (Pfizer’s Detrol LA/Detrusitol
XL)
- Extended-release oxybutynin (Johnson & Johnson’s
Ditropan XL/Lyrinel XL)
- Solifenacin (Astellas Pharma’s Vesicare)
- Darifenacin (Novartis/Procter & Gamble/Bayer
Vital/Ardana Bioscience’s Enablex/Emselex)
- Immediate-release trospium (Indevus/Allergan/Madaus’s
Sanctura/Spasmolyt)
Emerging therapies:
- Extended-release trospium (Indevus/Allergan/Madaus’s
Sanctura XR)
- Fesoterodine (Pfizer’s Toviaz)
- Botulinum toxin-A (Allergan’s Botox)
- YM-178 (Astellas Pharma)
- Elocalcitol (BioXell)
About DecisionBase
Urge Urinary Incontinence: Commercial Windfall Awaits the Treatment
That Offers Significant Improvement in Dryness Rates is a DecisionBase 2008
study from Decision Resources. DecisionBase 2008 combines market forecasts with
clinical and commercial end points to assess market share projections in 35
indications. These outputs are driven by quantitative and qualitative primary
research. DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market share
projections are based on prescriber surveys that compare physicians’
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.
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