As Old Bestsellers Plateau, a Look at 4 Next Generation Diabetes Drugs

The market

Again, the market for this one is potentially huge, but overlapping with current offerings. GLP-1 agonists look to be the future of type 2 diabetes treatments barring an oral insulin revolution, primarily because of their ability to produce an effect that mimics the body’s natural insulin-production process. There’s a generally agreed logic in healthcare that suggests that the closer any process is to nature, the safer and more beneficial it is. Natural stimulation like this is regarded as an improved mechanism of action over the introduction of synthetic insulin.

Since Novo already has a version of Victoza, its liraglutide GLP-1 receptor agonist, marketed for weight loss as Saxenda, semaglutide if approved will also be mostly maintenance of market share for the diabetes giant. Saxenda sales are growing at a rate of 27% quarterly. It is simply a higher dose of Victoza taken for the purpose of losing weight. Since Saxenda is already succeeding, approval for semaglutide is not critical, but could help Novo surround the market and secure its leadership even more .

iGlarLixi (previously Lixilan) from Sanofi SA (ADR) (NYSE:SNY)

iGlarLixi is Sanofi’s answer to iDegLira. It’s a combination treatment, comprised of lixisenatide, brand name Lyxuma, which is another GLP-1 receptor agonist comparable to Victoza, and Lantus (insulin glargine). We won’t go into the detail of the science on this one as it’s identical to iDegLira. What’s important to note here is that the two comparables – iGlarLixi and IDegLira – are essentially in a race to get approved and to market before the other. Both look good from a scientific perspective, but the one that gets an FDA green light first will have the advantage when it comes to getting a head start on marketing.  Which brings us to…

The Market

Again, this one has a potentially huge market if it can pick up an FDA approval, with the potential increasing if Sanofi can get the agency nod before Novo. Analysts put a conservative sales estimate peak on iGlarLixi at $1 billion, but will again cannibalize most of its sales from Lantus and Lyxumia. Approval is critical for Sanofi especially if iDegLira gets the go-ahead, which it likely will. Approval shouldn’t add too much to Sanofi’s top line, but it needs approval to maintain market share against encroaching advances of Novo Nordisk.

Current Status

This drug picked up an FDA panel advisory nod just two days after iDegLira, and the neck and neck standing between the two comes about as a result of Sanofi using a priority review voucher in an attempt to get ahead of Novo. Instead of getting ahead, it’s brought the two companies almost exactly in line on timeline, and who will pick up an approval first (assuming both do) is anyone’s guess. The panel didn’t vote unanimously on this one, so that gives Novo a slight edge. There were some concerns regarding labeling and how easy it would be to confuse the administration regimen but these seem to no longer be an issue based on anecdotal trial evidence. To put a timeframe on it, Sanofi SA (ADR) (NYSE:SNY) has this drug slated as a 2016 launch, so if it is going to pick up approval, expect it to do so before the close of the year.

Conclusion

These four new drugs are merely combination of what we know already works. The battle between Novo and Sanofi will continue through these next generation drugs. The edge has to be given to Novo Nordisk here, though both need these new combinations approved.

Note: This article is written by David Rich and originally published at Market Exclusive.