THE PIPELINE REPORT 2016 (V): Metabolic

LixiLan (lixisenatide/insulin glargine) Sanofi 

Indication: Type 2 diabetes (Ph.III) 
What the clinical trials found: In a Phase-III trial vs. Sanofi's Lantus, lixisenatide/insulin glargine combination met the primary endpoint of statistically superior reduction in HbA1c (LixiLan-L). The Phase III LixiLan-O trial found the fixed-ratio, once-daily injection of lixisenatide/insulin glargine combination superior to both Lantus (insulin glargine) and Sanofi's Lyxumia (lixisenatide) alone in reducing HbA1c. The combination was well-tolerated with few reported AEs. 
Credit Suisse Success Probability: 50%. Expected launch: 2017 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $975 million in annual global sales by 2020 
What the physicians are saying: Despite new therapy advancements, insulin patients continue to struggle with control. Our data over the past few years have shown an increase in GLP-1 use in combination with insulin, albeit at low levels. Given Lantus's strong standing in the market and the benefits attributable to GLP-1s, physicians will appreciate the convenience of the lixisenatide and Lantus combination. Notably, the addition of a GLP-1 to basal insulin offers the possibility of postprandial control without the risk of weight gain associated with adding a prandial insulin. And, it simplifies the regimen for patients who are already treating several other conditions in addition to diabetes. —Mary McBride, VP, GfK Roper Diabetes 

Semaglutide Novo Nordisk 

Indication: Type 2 diabetes (Ph.III) 
What the clinical trials found: The Phase-III SUSTAIN 3 trial showed that once-weekly injection of 1mg semaglutide provided better glycemic control and greater weight loss than 2mg AstraZeneca's Byetta once-weekly. Semaglutide was generally safe and well tolerated. 
Credit Suisse Success Probability and inThought Comment: 60%. The GLP-1 inhibitors are slowly emerging as having the best efficacy of the pre-insulin diabetes medicines, but there are already similar weekly formulations on the market. Perhaps this one will have a smaller needle or less injection site pain, but more interesting are the various combinations of GLP-1s with insulins or SGLT2 inhibitors. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $878 million in annual global sales by 2020 
What the physicians are saying: The GLP-1 market is increasingly crowded, with several once-weekly subcutaneous injection options already on the market. While GLP-1s have been available for more than a decade, uptake has been slow. Where semaglutide will set itself apart is with its oral formulation (O62175C), currently out of Phase II trials. This will appeal to physicians looking to move needle-adverse patients onto a GLP-1. Recent results from SUSTAIN-2 are favorable for semaglutide's subcutaneous formulation, and if the oral formulation performs well on efficacy and safety, physician uptake will follow. —Mary McBride, VP, GfK Roper Diabetes 

MK-1293 (insulin glargine biosimilar) Merck/Samsung Bioepis

Indication: Type 1\2 diabetes (Ph.III) 
What the clinical trials found: In a Phase III study vs. Sanofi's Lantus, the mean change in hemoglobin A1c (A1C) from baseline after 24 weeks is non-inferior in Type 1 diabetes participants treated with MK-1293 (insulin glargine biosimilar). No major safety issues seen. 
inThought Comment: Biosimilar insulins will be an easier sell to doctors than biosimilars for rheumatoid arthritis or cancer. We expect this to be taken up fairly efficiently, and more importantly, for biosimilar insulins to become cornerstones of diabetes franchises. 
What the physicians are saying: Merck and Samsung Bioepis's MK-1293 is one of several insulin glargine biosimilars looking to take share from Lantus. While physicians appreciate the cost savings and expanded insulin options biosimilars will provide, the speed with which physicians are ready to move patients to MK-1293 remains to be seen. Uptake will require strong supporting data and a comfort level that transitioning to a biosimilar will be in the patient's interest. A wait and see attitude will prevail among those requiring reassurance that the differences between MK-1293 and Lantus are not clinically meaningful. Uptake will also be linked to MK-1293's ability to obtain interchangeability status with Lantus at the pharmacy. —Mary McBride, VP, GfK Roper Diabetes

Ver anterior: 
THE PIPELINE REPORT 2016 (IV): Cardiology