1. By Will Roettger
Principal Consultant
20/20 Market Insights, LLC
January
31,
2012

2. Will Roettger is an established career professional in the
pharmaceutical and biotech industry. Having worked for Novartis,
AstraZeneca, Merck, Alexion, and Dendreon he has developed
expertise across the therapeutic areas of oncology, hematology, and
immunology for pipeline and launch products. He has been
instrumental in establishing marketing intelligence as a core capability
in support of clinical and commercial new product development, solving
the many commercial challenges that high-priced specialty products
face from a patient, provider, and investor perspective. Additionally he
has supported two specialty product launches, providing actionable
insights and recommendations by integrating market research findings
with competitive intelligence. As a principal for 20/20 Market Insights,
LLC, he is dedicated to providing clients with clear vision into
competitor landscapes, strategies, and product assessments that drive
strategic business decisions in new drug development.
Contact Information:
Will Roettger
Principal Consultant
20/20 Market Insights, LLC
908-391-4362
will.roettger@gmail.com
2

4. Amylin Pharmaceuticals, Inc., Eli Lilly & Company and Alkermes, Inc. announced results from the
DURATION-4 study, the 4th in a series of studies designed to test the superiority of Bydureon™
(exenatide extended-release for injectable suspension), an investigational type 2 diabetes (T2D)
therapy, as compared to other T2D medications.
This 26-week clinical study compared Bydureon monotherapy to Januvia® (sitagliptin), Actos®
(pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in
the treatment of T2D.
Participants in this study had not achieved adequate A1C control using diet and exercise, and were
not on any diabetes therapy when they entered the study. After 26 weeks of treatment, patients
randomized to Bydureon achieved a reduction in A1C of 1.5% from baseline, which was significantly
greater than the reduction of 1.2% for Januvia. Patients randomized to metformin achieved a
reduction in A1C of 1.5%, and patients receiving Actos achieved a reduction of 1.6%.
This briefing summarizes the results of this study and identifies resulting clinical and commercial
questions that remain for Novo Nordisk who markets a competitor GLP-1 agonist

10. Russell-Jones D et al. Dia Care 2012;35:252-258

11. Bydureon provided greater
improvements than Januvia, same
improvements as metformin, and
less improvement than Actos
Bydureon and metformin produced
greater weight loss

14. Bydureon demonstrated similar
superior results in the
DURATON-2 study achieving A1c
reductions by -1.5% at 26-weeks
Bydureon shows a rapid drop in HbA1cin the first
12-14 weeks where it levels off. Then there is a
slight rise – perhaps again due to compliance.

19. Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
908-­‐391-­‐4362
will.roettger@gmail.com
19

23. Bydureon
vs.
Victoza
Bydureon

24. The insulin market is
comprised of three segments:
Fast acting, pre-mix, long
acting

25. Tight glycemic control
reduces risk of micro and
macro vascular
complications

26. The
ADA
and
EASD
recommend
the
use
of
GLP-­‐1
agonists
as
a
tier
2
treatment
option
after
metformin
for
T2D
patients

27. Glucagon-like peptide 1 (GLP-1) agonists
Product
Generic
Name
Company
Patent Expiry
2008
2014
Phase
Oct 2017
-
1,662
-
-
950
Phase III
Dec 2017
-
933
Marketed
Byetta LAR
exenatide
Eli Lilly/ Amylin
Pharmaceuticals
Filed
RG1583
taspoglutide
Roche/ Ipsen
Victoza
liraglutide
Novo Nordisk
Syncria
albiglutide
GlaxoSmithKline
-
-
208
Phase III
Byetta
exenatide
Eli Lilly/ Amylin
Pharmaceuticals
Oct 2017
752
206
Marketed
AVE-0010
(ZP-10)
-
Sanofi-Aventis
Dec 2020
-
88
Phase III