What options are left for treating Type 2 patients?
According to a new analysis of several large clinical trials long term use of Avandia or Actos doubles the risk of bone fractures in women. Dr. Sonal Singh of Wake Forest University School of Medicine indicated that researchers knew of the risk but not the magnitude of the risk. According to Dr. Lorraine Lipscombe of the University of Toronto; “This evidence adds to the growing concern regarding these drugs, which have also been associated with a higher risk of heart failure and possibly heart attacks.”
Nearly 4 million patients take either Avandia or Actos with nearly half of whom are women.
This news comes on the heels of concerns over Byetta and pancreatitis, according to Amylin (NASDAQ:AMLN) there are nearly one million patients using Byetta. While Diabetic Investor believes there is no solid evidence linking Byetta as the cause of the pancreatitis, these concerns have hurt Byetta sales as physicians are waiting for further guidance from the Food and Drug Administration (FDA). Just last week Amylin indicated they would not have a decision from the FDA on a possible label change for Byetta until early 2009.
While Januvia from Merck (NYSE:MRK) continues to benefit from the troubles of other type 2 medications, Januvia has its own set of issues as it has been associated with a serious form of skin cancer. It should be noted that the most prescription data indicates that the drug is not gaining new market share and new prescriptions appear to be decreasing. Diabetic Investor believes that this slowing growth is associated with the rather lackluster performance of Januvia. Based on numerous patient and physician interviews glucose lowering only appears when Januvia is used in conjunction with metformin. Given the high cost of Januvia and its sister drug Janumet (Januvia and metformin in one pill) it’s not surprising that physicians and patients are opting to use metformin alone or in conjunction with other generics rather than pay the additional cost for Januvia.
It should also come as no surprise that insulin usage in Type 2 patients is increasing. Physicians are well aware of insulin’s risk/reward profile, in particular hypoglycemia, however given all the concerns with alternative therapies they feel comfortable prescribing insulin for their type 2 patients. It doesn’t hurt matters that insulin companies have finally awakened to the fact that patients prefer simple insulin delivery systems like insulin pens. It’s no accident that at the same time insulin use is increasing so is the growth in insulin pen usage.
Looking towards the future Diabetic Investor sees the type 2 medication market transforming from an oral based market to increased use of Injectables, such as insulin and Byetta. While injectable therapy options will not become the primary therapy option, they will continue to gain share. The real test will come when the FDA looks at the newer injectable options like the once-a-week version of Byetta, Byetta LAR.
As powerful as insulin can be the drug has several drawbacks when used in the type 2 population. Besides the risk of hypoglycemia a serious and possibly life threatening adverse event, patients often experience weight gain which leads to a host of other issues. Add in the fact that unlike Byetta or Byetta LAR, insulin is does dependent requiring patients to regularly monitor their glucose levels. As Diabetic Investor has pointed out in the past, even with all the advancements in glucose monitoring technology type 2 patients are the least frequent testers. Finally, insulin use requires education something most primary care physicians, who treat nearly 80% of patients with diabetes, fail to provide.
While there is some education involved with Byetta usage, it does not come close to what’s needed when a patient adds insulin to therapy regimen. Byetta has perhaps the simplest dosing option and even better little, if any, risk of hypoglycemia. Add in the fact it provides excellent results and often produces significant weight loss and you can see why physicians are anxiously awaiting more data on the pancreatitis issue.
Novo Nordisk is also aware of this trend toward injectable therapy options and the growing interest in GLP-1 therapy. Waiting in the wings is liraglutide their once-daily GLP-1. Like Byetta, liraglutide has proven to a powerful drug although study data indicates its weight loss capabilities have fallen short of what we’ve seen with Byetta. Diabetic Investor doesn’t see this as a major obstacle to physicians prescribing liraglutide as many will prefer its once daily administration to Byetta’s twice daily administration.
Like their major competitor Lilly (NYSE:LLY), Novo is also working on advanced insulin’s that work longer making for less frequent injections. Early data also suggest that these newer insulin are also weight neutral.
Sitting with a big smile and watching all this are companies like Becton Dickinson (NYSE:BDX), the leader in syringe and insulin pen needle technology. Whether physicians turn to insulin or GLP-1 therapy, both must be delivered via injection and that means either a syringe or pen delivery system. Although not nearly as exciting as drug development the syringe and pen needle market carries some nice margins and is a very steady business. Sometimes being the leader in a rather boring market segment isn’t that bad.
Some might point out there are a host of companies with oral medications in their pipelines which look very promising. This is true however Diabetic Investor is not ready to endorse any of these early and mid-stage projects especially under the current regulatory environment. Solid data is one thing, getting the drug to market is a completely different story which we see only getting more difficult.
Take away the concerns over pancreatitis and GLP-1 therapy remains the most promising option for treating the growing type 2 patient population. Unless there is something we don’t know all available evidence indicates this concern is over blown and should be debunked as more data is made public and analyzed in the proper context. The fact the Amylin announced that the regulatory submission for Byetta LAR remains on track is the first sign that this issue will not, pardon the pun, and stick around for too much longer.
The ultimate loser here just might be Sanofi-Aventis (NYSE:SNY) the makers of Lantus. Lantus became the world’s number selling insulin mainly due to it usage with type 2 patients. Given the option of injecting Lantus seven times per week plus taking oral medications or taking one injection per week with no oral medications Diabetic Investor suspect’s physicians and patients will choose the later rather than the former.
While it may seem obvious to everyone but the analysts who cover this space, the winner in the type 2 medication market will be drug that combines the best overall control, carries the lowest risk of hypoglycemia, is at least weight neutral and comes with a simple, less frequent dosing administration. Call Diabetic Investor crazy, and we’ve been called much worse, this sounds like Byetta LAR.