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.
20/20 Market Insights, LLC
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
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.