Sunday, May 27, 2012

Highlights of ADA -2012 - A Quick preview

Phase 2 data on Lilly's  basal insulin at ADA - Investors would compare it to Nordisk's Degludec
At ADA, we would see the for the first time Phase II data for Lilly's novel basal insulin analogue (LY2605541). The abstract has been published and it appears the profile of LY2605541 is better than Sanofi's Lantus and comparable to Novo's Degludec.  On the hypoglycemia front, LY2605541 appears better than Lantus, but slightly less effective than Novo's degludec while  on the weight front, LY2605541 reduced weight by 0.8-1.9kg compared to Lantus, which is better than Degludec

Highlights of Phase 2 data
  1. 20-50% reduction in nocturnal hypoglycemia vs Lantus, with similar/higher overall hypoglycemia vs Lantus. This is slightly lower than than 40-50% reduction in nocturnal and c20% reduction in overall hypoglycemia demonstrated by Degludec vs Lantus in Phase III studies;
  2.  0.8-1.9kg weight reduction vs Lantus, a potential advantage vs Novo's Degludec (weight neutral vs Lantus)
  3.  Key side effects included liver enzyme elevation, change in lipid profile, but did not exceed the limits and GI disturbances. 
We would llike to get a feedback from physician who are reading this post on  how competitive LY2605541's hypoglycemia and weight benefit is perceived to be relative to Degludec's hypoglycemia profile, flexible dosing regime and availability of high concentration formulation.  

 About LY2605541- LY2605541 is once daily insulin (basal insulin)  in Phase 3 development and is supposed to have a better hypoglycemia and weight  profile compared to existing standard of care - Lantus

About Insulin Degludec -Ultra-long-acting insulin degludec, under development by Novo Nordisk, lowers blood glucose levels with significantly reduced rates of hypoglycaemia (low blood sugar) compared to insulin glargine / Lantus, according to data presented at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego


Phase 3 data on Albiglutide in combination with Lantus and head to head with Victoza - Abstracts published
Abstracts confirm prior headline data for HARMONY-6 (combo with Lantus vs Lantus plus bolus insulin) and HARMONY-7 (head to head vs Victoza). 

Harmony 7  Data
Data suggests:
  1. HbA1c reduction 0.2% lower than Victoza  and marginally lower than Bydureon (on cross-trial comparison); 
  2.  Weight loss of 0.6-1.0kg less than 2-3kg seen with both Victoza and Bydureon; 
  3.  Nausea rates of 10% better than the c15% rate with Bydureon and c25% rate with Victoza;
  4.  Injection site reactions of 10% greater than the c2% with Victoza though better than the c15% with Bydureon. 
We would appreciate feedback from physician reading this post on whether a favourable tolerability profile, with a convenient weekly injection, can allow niche positioning within the GLP-1 market despite efficacy and weight disadvantages. 

About Albiglutide  Albiglutide is a GLP-1 analog under investigation in Phase 3 trial  by GSK for treatment of  type 2 diabetes. Like Bydureon , it is to be administered once weekly. Novo's Victoza is administered once daily.