The Fun is Just Beginning

The Fun is Just Beginning

Just as Diabetic Investor suspected it didn’t take long for Novo Nordisk (NYSE:NVO) to start pushing Levemir as a replacement for Lantus. Novo reps are already out in the field calling on physicians pushing Levemir as “safe” replacement. We can’t say we’re surprised by this move as Novo hired a host of new reps who we’re supposed to sell Liraglutide, which is currently stalled at the FDA. Novo senses an opportunity here and is pushing full steam ahead while the Lantus controversy is fresh in everyone’s mind.

To show the lengths Novo will go to consider the following passage in a statement the company issued on Sunday;

“Studies on receptor binding have shown that Levemir® in comparison to human insulin has a relative affinity to the IGF-1 receptor which is equal to or slightly lower than to the insulin receptor.4,5. Levemir® distinguishes itself from insulin glargine, which has been shown to have increased affinity for the IGF-1 receptor compared to human insulin4,5,6 .

This not so subtle paragraph is a perfect example of how Novo likes to play. While there statement generally supports the use of insulin analogues they can’t help but take a nice little swipe at the competition, talking about kicking a wounded dog. This is exactly the same tactic the company pursued when they did everything they could to taint Byetta and Byetta LAR with the thyroid cancer issue which is linked to their GLP-1 Liraglutide. Every chance they could the company would call this issue a class effect for all GLP-1’s.  A statement which really isn’t accurate as the company is taking wide liberties with a statement made by the FDA. The fact’s don’t support Novo’s claim but Novo has never let the facts stand in the way of gaining market share or slowing down a competing drug which is also at the FDA.

After speaking with several noted physicians Diabetic Investor believes this push by Novo could backfire. First and foremost, we have yet to find one respected researcher who actually believes Lantus causes cancer.  Second, while Levemir and Lantus are both long-acting insulin analogues they are really two different drugs which are not necessarily interchangeable. A physician cannot simply take a patient off Lantus and put them on Levemir.

It’s critical at this juncture that Sanofi-Aventis (NYSE:SNY) begin to fight back. The company should be distributing the statements made by the American Diabetes Association (ADA) and European Medicines Agency (EMA) which support Lantus and bring to light issues with the published studies.

According to the EMA statement ; “The results of the four studies were found to be inconsistent. In two studies (Scottish Diabetes Research Network Epidemiology Group and Jonasson et al) an association between breast cancer was found in a group of patients taking insulin glargine as monotherapy, but not in another group of patients using insulin glargine together with other types of insulin. For other cancers, no association was found. In these two studies dose-dependency was not evaluated. The third study (Hemkens et al) reported a dose-dependent association between use of insulin glargine and malignancies. However, no information is available on the types of cancer found in this study. In the fourth study (Currie et al), no association between cancer (either breast, colorectal, pancreatic or prostate cancer) and the use of insulin glargine, or any other insulin, was found.”

According to the ADA statement; “Findings from these research papers are conflicting and inconclusive, and the American Diabetes Association cautions against over-reaction until more information is available.”

Second, the company should quickly put together a panel of experts to field questions in a public forum. The faster they can cast doubt on the quality of this research the better. There are so many holes in how these studies were done the company has an opportunity to debunk their findings.

Given that Novo has decided to exploit this situation for their purposes Sanofi should not underestimate just how far Novo will go. There are billions of dollars at stake not to mention millions of patients. Sanofi actually has a great opportunity here to score points with the diabetes community. By easing patient concerns they would seen as the good guys.  Well executed they would also place Novo in a very bad light. The fact is no one likes it when companies exploit serious health issues for their own benefit.

Diabetic Investor has long admired Novo Nordisk however their recent actions are troubling. We understand that billions of dollars are stake and the company has an obligation to their shareholders to maximize shareholder value. However, the company also has a moral obligation to the millions of patients with diabetes and the physicians that treat them. These recent wink and nod tactics only diminishes the reputation of a once fine company.  

Novo would be wise to follow the words of Abraham Joshua Heschel; “The essence of man, his uniqueness, is in his power to surpass the self, to rise above his needs and selfish motives.”