 DecisionBase PDFs --
2008
 Overview:
The PAH pipeline, larger than ever before (more than 15
compounds in clinical development), is burgeoning with promising agents that
exploit both established approaches, such as endothelin receptor antagonism and
phosphodiesterase (PDE)-5 inhibition, and new approaches, mainly in Phase I and
II development. Late-stage trials investigating drugs launched for unrelated
indications but with potential utility in PAH have been initiated by firms
seeking new revenue channels and have boosted the late-stage PAH pipeline, to
the enthusiasm of PAH specialists. These specialists are hopeful that one of
these compounds in particular, Novartis’s imatinib (Gleevec/Glivec), will
improve on the antiproliferative capabilities of marketed drugs and reverse
pulmonary vascular remodeling to an unprecedented degree.
Questions Answered in This Report:
 A drug’s performance on as many as seven efficacy end points,
including observed survival and change in exercise capacity, 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
pulmonologists weight efficacy measures and other drug attributes in their
prescribing decisions for PAH?
Bosentan (Actelion’s Tracleer) is the 2006 major-market
sales leader for pulmonary arterial hypertension. How will bosentan and other
current therapies fare against emerging therapies? Will emerging therapies
offer improvements in the efficacy end points and drug attributes that are most
influential in physician prescribing decisions? If so, which drugs will suffer
the most from entry of these new agents?
By 2011, imatinib (Novartis’s Gleevec/Glivec) will emerge as
the gold-standard therapy in our drug comparator model because
of its improved clinical profile over the current therapies evaluated in this
study. On what clinical attributes is imatinib most differentiated from its
competitors? Which current therapies are at greatest risk of being replaced by
imatinib?
Scope:
Key drug development opportunity tested in our target
product profiles for pulmonary arterial hypertension: A therapy that improves
six-minute walking distance (6MWD) from baseline by a greater percentage than
bosentan at 16 weeks.
Physicians surveyed for this study: 60 U.S. pulmonologists.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Bosentan (Actelion’s Tracleer)
- Ambrisentan (Gilead’s Letairis/GlaxoSmithKline’s Volibris)
- Epoprostenol (GlaxoSmithKline/Gilead’s Flolan)
- Sildenafil (Pfizer’s Revatio)
- Inhaled iloprost (Bayer Schering/Actelion’s Ventavis)
Emerging therapies:
- Inhaled treprostinil (United Therapeutics)
- Tadalafil (Eli Lilly’s Cialis)
- Aviptadil (Biogen Idec)
- Imatinib (Novartis’s Gleevec/Glivec)
- Actelion-1 (Actelion)
About DecisionBase
Pulmonary Arterial Hypertension 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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