 DecisionBase PDFs --
2008
 Overview:
Type 2 diabetes is a highly prevalent, chronic disorder that
requires lifelong treatment. Metformin has become the most commonly prescribed
oral antidiabetic agent in part because of its relatively benign safety and
tolerability profile. The agent carries a low risk of hypoglycemia and does not
cause weight gain. However, most patients require treatment with additional
agents to maintain glycemic control, and there is significant unmet need for
novel therapies that offer improved efficacy, safety, and tolerability over
currently marketed agents. Indeed, the type 2 diabetes market presents immense
opportunity that has fueled intense research. More than 300 investigational
compounds are in active preclinical and clinical development with a late-stage
pipeline dominated by peroxisome proliferator-activated receptor (PPAR)
agonists, glucagon-like peptide 1 (GLP-1) analogues, and dipeptidyl peptidase
IV (DPP-IV) inhibitors.
Questions Answered in This Report:
 The goal of therapy for type 2 diabetes is the reduction of
blood glucose levels to prevent the development of diabetic complications
resulting from chronic hyperglycemia. What are the key primary and secondary clinical
trial end points with which new therapies are evaluated? How do primary care
physicians weight specific efficacy end points and other drug attributes in
their prescribing decisions for type 2 diabetes?
Metformin (Bristol-Myers Squibb’s Glucophage, generics) is
expected to maintain its dominant position among therapies for type 2 diabetes
for the foreseeable future. However, by 2011 Novo Nordisk’s liraglutide will
emerge as the gold-standard therapy in our drug comparator model because of its
superior clinical profile over the current therapies evaluated in this study. On
what clinical attributes is liraglutide most differentiated from its
competitors? Which current therapies are at greatest risk of being replaced by
liraglutide?
Pioglitazone (Takeda’s Actos) is the 2006 major-market sales
leader for type 2 diabetes. Sales for pioglitazone have grown significantly
since the agent’s 1999 launch in the United States, despite the side effects of
weight gain, edema, and elevated risk for congestive heart failure associated
with its use. In 2007, the FDA mandated the addition of a black box warning for
pioglitazone and another drug in its class, rosiglitazone (GlaxoSmithKline’s
Avandia), to highlight the elevated risk for congestive heart failure. Do
thought leaders expect emerging therapies to offer significant improvements in
efficacy, safety and tolerability, or delivery over pioglitazone? Which
emerging therapies pose the greatest threat to pioglitazone?
Scope:
Key drug development opportunity tested in our target
product profiles for type 2 diabetes: A weight-neutral oral antidiabetic drug
for the treatment of type 2 diabetes.
Physicians surveyed for this study: 60 U.S. primary care physicians.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Pioglitazone (Takeda’s Actos)
- Rosiglitazone (GlaxoSmithKline’s Avandia)
- Metformin (Bristol-Myers Squibb’s Glucophage, generics)
- Glimepiride (Sanofi-Aventis’s Amaryl, generics)
- Sitagliptin (Merck’s Januvia/Xelevia, Banyu/Ono's Glactiv)
Emerging therapies:
- Vildagliptin (Novartis)
- Dapagliflozin (Bristol-Myers Squibb/AstraZeneca)
- Liraglutide (Novo Nordisk)
About DecisionBase
Type 2 Diabetes: Blockbuster-Bound Januvia Addresses
Physicians’ Concern over Hypoglycemia 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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