Type-2 Diabetes Competitor Threat Assessment - Bydureon DURATION-4 Briefing (013112)


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Type-2 Diabetes Competitor Threat Assessment - Bydureon DURATION-4 Briefing (013112)

  1. 1. By Will Roettger Principal Consultant 20/20 Market Insights, LLC January  31,  2012  
  2. 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  
  3. 3. 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
  4. 4. Russell-Jones D et al. Dia Care 2012;35:252-258
  5. 5. Bydureon provided greater improvements than Januvia, same improvements as metformin, and less improvement than Actos Bydureon and metformin produced greater weight loss
  6. 6. 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.
  7. 7. Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   19  
  8. 8. Bydureon  vs.  Victoza   Bydureon  
  9. 9. The insulin market is comprised of three segments: Fast acting, pre-mix, long acting
  10. 10. Tight glycemic control reduces risk of micro and macro vascular complications
  11. 11. The  ADA  and  EASD  recommend  the  use  of  GLP-­‐1   agonists  as  a  tier  2  treatment  option  after  metformin  for   T2D  patients  
  12. 12. 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