Introduction:
The pharmaceutical market for chronic obstructive pulmonary
disease (COPD) has yet to realize its maximum commercial potential. Population
aging and increases in diagnosis rates will drive expansion of the drug-treated
pool of COPD patients over the next ten years. A
disease-modifying therapy that can halt the decline in lung function and/or
repair damaged lung tissue in COPD patients is needed, but emerging
therapies will not address this need. They will offer only incremental
improvements (e.g., new formulations, new combinations) over existing agents. Second-generation,
long-acting beta
2 agonist (LABA)/inhaled corticosteroid (ICS)
combinations, long-acting muscarinic antagonists (LAMAs), and LABA/LAMA
products will emerge, and many will provide convenient, once-daily
dosing and slightly better efficacy and safety profiles than the first generation of drugs
in these classes.
Questions Answered in This Report:
*
Lung function improvement, reduction in exacerbations, changes
in dyspnea, quality of life improvement, and effect on mortality are key goals
in the treatment of COPD.
What are the key primary and secondary clinical
trial end points with which new therapies
are evaluated? How do U.S. and European primary care physicians (PCPs) and
general practitioners (GPs) weight
specific efficacy end points and other drug attributes in their prescribing
decisions for COPD?
*
Salmeterol/fluticasone (GlaxoSmithKline’s Advair/Seretide,
GlaxoSmithKline/Mitsubishi Tanabe’s Adoair) is
the 2008 major-market sales leader for COPD.
How will emerging therapies
fare against salmeterol/fluticasone? 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 salmeterol/fluticasone?
*
Based on its clinical profile, tiotropium (Boehringer
Ingelheim/Pfizer’s Spiriva) 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 tiotropium as the future gold standard in 2013 or 2018?Scope:
Key drug development opportunity tested in our target
product profiles for COPD: a therapy that is a single-inhaler, once-daily
LABA/LAMA combination for the treatment of moderate to very severe COPD.
Physicians surveyed for this study: 60 U.S. and 30
European PCPs and GPs.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Salmeterol/fluticasone (GlaxoSmithKline’s Advair/Seretide,
GlaxoSmithKline/Mitsubishi Tanabe’s Adoair)
- Formoterol/budesonide (AstraZeneca/Astellas’s Symbicort)
- Tiotropium (Boehringer Ingelheim/Pfizer’s Spiriva)
- Albuterol/ipratropium (Boehringer Ingelheim’s Combivent)
- Arformoterol (Sepracor’s Brovana)
Emerging Therapies
- Aclidinium (Forest/Almirall’s Eklira)
- Indacaterol (Novartis’s QAB-149/Onbrez)
- Olodaterol/tiotropium (Boehringer Ingelheim)
- Indacaterol/glycopyrronium (Novartis’s QVA-149)
- Roflumilast (Forest/Nycomed/Mitsubishi Tanabe’s Daxas)