Lost in the shuffle

Lost in the shuffle

With Roche and Novo Nordisk (NYSE:NVO) reporting results yesterday, some may have missed the news from Sanofi-Aventis (NYSE:SNY) who yesterday released results of their GetGoal-X clinical study for their once daily GLP-1 lixisenatide. According to a press release issued by the company;

The GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily. In addition, the initial results showed that significantly fewer people with type 2 diabetes treated with lixisenatide once-daily reported hypoglycemic events versus patients treated with exenatide. In the lixisenatide arm, three-fold fewer people reported symptomatic hypoglycemia than people who were on exenatide (2.5% vs 7.9%; p<0.05). Six-fold fewer hypoglycemia events were observed in patients on lixisenatide than those treated with exenatide (8 vs 48 events). Other endpoints were broadly consistent with what has been observed with other GLP-1 agonists.”

This news from Sanofi further reinforces what Diabetic Investor has been stating in that GLP-1 therapy is gaining traction as a primary treatment option for type 2 diabetes. It’s also somewhat ironic that yesterday Roche noted they have abandoned taspoglutide, just as Diabetic Investor predicted they would, and given the drug back to Ipsen. In another somewhat ironic twist, there are some similarities between how Roche reported results for taspoglutide and how Sanofi is reporting results for lixisenatide.

Just as Roche’s press releases for taspoglutide where short on data, the Sanofi release also is void of any hard data and like Roche uses the phrases non-inferiority and meeting primary endpoints with regularity. Back when Roche was releasing limited hard data on taspoglutide Diabetic Investor noted that the absence of hard data was a troubling sign for the drug. Our basic thought process was that if the data was really that good the company would have no problem sharing it. Now we have no knowledge that there are any issues with lixisenatide but this absence of hard data makes us wonder.

The central fact is that, just as the insulin market has evolved over the years, the GLP-1 will also evolve to the point where there will be several me-too products. Also like the insulin market, where product development is centered on developing insulin’s that require fewer administrations, the GLP-1 market is moving in this same direction. As everyone knows Bydureon, the once-weekly GLP-1 from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) is waiting for FDA approval and Amylin has noted that they are also working on a once-monthly version of Bydureon.

The final similarity between these two markets is the players involved. It’s no accident that Lilly, Sanofi and Novo, just as they have battled for supremacy in the insulin market, they will expand this fight to the GLP-1 market. Like Diabetic Investor, these companies understand that GLP-1 therapy has the potential to forever change the way physicians treat type 2 diabetes. They also understand that this shift in treatment strategy does not bode well for their respective insulin franchises. The stark reality for all three is they cannot be a key player in diabetes without a GLP-1 offering.

While 2011 may be a transformational year for the diabetes, when it comes to the evolving GLP-1 market, the more things change the more they stay the same. The drug may be different but the players remain the same. At the moment Diabetic Investor gives the edge to the Amylin/Lilly/Alkermes alliance and their once-weekly GLP-1 Bydureon, but as we have seen many times before Novo and Sanofi will not surrender this valuable market without putting up a strong fight. The fact is whether it’s insulin or GLP-1’s, these three players will not surrender on any front and will use whatever means necessary to gain a leg up on their rivals. Game On!!!!