Introduction:
Although generic oral therapies are the mainstay of first-
and second-line treatment of type 2 diabetes, this indication still offers
significant commercial potential thanks to its high prevalence and the
less-than-optimal efficacy and safety of current drugs. Competition in this
market will increase significantly in the next ten years as a result of the
anticipated launch of more than 20 novel therapies for type 2 diabetes and the
loss of patent protection of the sales-leading PPAR-gamma agonists. However, no
therapies in development offer both the efficacy and safety that physicians
desire. In particular, there is great potential for conveniently delivered
drugs that can elicit significantly greater reductions in HbA
1c and
body weight without triggering hypoglycemia.
Questions Answered in This Report:
*
Improved glycemic control and reduction of body weight are key
goals in the treatment of type 2 diabetes.
What are the key primary and
secondary clinical trial end points with which new therapies are evaluated? How
do U.S. and European endocrinologists weight specific efficacy end points and
other drug attributes in their prescribing decisions for type 2 diabetes?
*
Pioglitazone (Takeda’s Actos) was the major-market sales leader
for type 2 diabetes in 2008.
How will pioglitazone 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 most from entry
of these new agents?
*
By 2013, exenatide LAR (Amylin/Eli Lilly/Alkermes’ Byetta LAR)
will emerge as the gold-standard therapy in our Drug Comparator Model because
of its superior clinical profile compared with the current therapies evaluated
in this study.
On what clinical attributes is exenatide LAR most
differentiated from its competitors? Which current therapies are at greatest
risk of being replaced by exenatide LAR?Scope:
Key drug development opportunity tested in our target
product profiles for type 2 diabetes: a once-weekly GLP-1 analogue.
Physicians surveyed for this study: 60 U.S. and 31 European
endocrinologists.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Metformin (Bristol-Myers Squibb/Merck Serono’s
Glucophage/Glucophage XR, Biovail/DepoMed’s Glumetza, Watson’s Fortamet,
generics)
- Glimepiride (Sanofi-Aventis’s Amaryl, generics)
- Sitagliptin (Merck’s Januvia)
- Pioglitazone (Takeda’s Actos)
- Exenatide (Amylin/Eli Lilly’s Byetta)
Emerging Therapies
- Exenatide LAR (Amylin/Eli Lilly/Alkermes’ Byetta LAR)
- Liraglutide (Novo Nordisk’s Victoza)
- Saxagliptin (Bristol-Myers Squibb/AstraZeneca’s Onglyza)
- Dapagliflozin (Bristol-Myers Squibb/AstraZeneca)
- Metaglidasen (Metabolex/Ortho-McNeil)