Introduction:
Three highly efficacious biologics are competing for
leadership in the psoriasis market: the historical and 2009 sales leader,
etanercept (Amgen/Pfizer/Takeda’s Enbrel); the most recently approved TNF-α
inhibitor, adalimumab (Abbott/Eisai’s Humira); and the first interleukin (IL)
inhibitor launched for psoriasis, ustekinumab (Centocor Ortho
Biotech/Janssen-Cilag’s Stelara). The anticipated market entry of a second IL
inhibitor, Abbott’s briakinumab, in early 2011 will further expand treatment
options and challenge the dominance of the TNF-α inhibitors as first-line
biologics. Although each of the marketed biologics offers significant
improvements in efficacy and/or dosing over its predecessors, important
opportunities remain for new agents that demonstrate safety benefits with
long-term administration.
Questions Answered in This Report:
*
A drug’s ability to induce PASI 75 response at 12 weeks has
been the standard efficacy end point assessed in late-phase trials for
psoriasis, but it is not commonly used in medical practice.
How do U.S. and
European dermatologists weight specific efficacy end points and other drug attributes
in their prescribing decisions for psoriasis? What are the key primary and
secondary clinical trial end points evaluated in ongoing trials of new
therapies seeking regulatory approval for psoriasis?
*
Etanercept is the 2008 major-market sales leader for psoriasis.
How will etanercept 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?
*
Based on its clinical profile, ustekinumab is the 2009 clinical
gold standard in our Drug Comparator Model.
What attributes do thought
leaders believe differentiate this drug from competing current and emerging
therapies? Will any drugs in development challenge ustekinumab as the gold
standard for 2013 or 2018?Scope:
Key drug development opportunity tested in our target
product profiles for psoriasis: A biological agent that carries a lower theoretical
risk of malignancies than biologics currently marketed for the treatment of
psoriasis.
Physicians surveyed for this study: 60 U.S. and 30
European dermatologists.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Etanercept (Amgen/Pfizer/Takeda’s Enbrel)
- Adalimumab (Abbott/Eisai’s Humira)
- Infliximab (Centocor Ortho Biotech/Merck/Mitsubishi Tanabe’s
Remicade)
- Methotrexate (Dava’s Rheumatrex, generics)
- Ustekinumab (Centocor Ortho Biotech/Janssen-Cilag’s Stelara)
Emerging Therapies
- Briakinumab (Abbott)
- Apremilast (Celgene)
- Voclosporin (Isotechnika Pharma)
- AIN-457 (Novartis)
- Fezakinumab (Pfizer)