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You can watch this interview now on Diabetes Health TV.
SK: We’re joined on our show by Craig Eberhard, vice president of sales at Amylin Pharmaceuticals. Hey, Craig, thanks for coming on the show. Amylin has one of the most innovative products that I’ve heard of in years. It’s called Byetta.
I have friends who have lost 100 pounds taking this product. I know people who are taking it off-label to lose weight, including people who are pre-diabetic. Craig, it seems that you have a huge market for this. Let’s talk about who it’s indicated for.
CE: Byetta is indicated for patients with type 2 diabetes who have failed on either metformin, sulfonylurea, TZD or any combination of those, so it’s not indicated as a monotherapy but as an adjunctive therapy to oral medications.
SK: OK, let’s stop there. Why not? Why shouldn’t a new type 2 who’s overweight take your product?
CE: Well, we’re doing studies and actually have submitted them to the FDA forum on monotherapy. The initial indication and studies on Byetta were for adjunctive therapy. A typical patient’s going to go on metformin or some other form of oral therapy, and then progress to a number of orals and then eventually to insulin. So, Byetta is indicated prior to insulin and there are some definite advantages to it not only in terms of glucose control but weight benefits for most patients. And it’s a single dose - you don’t have to titrate and you don’t become hypoglycemic when you use it in combination with metformin.
(Editor's Note: Amylin and Eli Lilly report that in a 24-month study of Byetta as a standalone therapy, participants experienced reductions in A1c of from 0.7 percent to 0.9 percent. Sixty percent of participants ended the study with A1c's of 7 percent or less, the American Diabetes Association's target for glucose control. The companies plan to submit their findings to the Food and Drug Administration by July in the hopes of gaining approval for Byetta as a monotherapy.)
SK: Now, Craig, when you say it’s indicated before insulin, is that like somebody decides the order that these drugs are going to be prescribed in? Who does that?
CE: Well, it’s not that somebody arbitrarily decides, it’s that [using] the drug makes sense. If you look at actual clinical studies where Byetta has been utilized, you see a medication that controls your blood sugar but can also help you maintain - or in most patients, lose weight - that’s beneficial. As you know, with many oral medications, and certainly insulin, you can have weight gain associated with your usage of the product. Byetta has some sort of satiety or neuro-hormonal effect where you eat less, so it’s nothing more magical than that you feel full and don’t eat as much.
SK: I’m still confused as to why someone wouldn’t want to take this right off the get-go and avoid all of the failures of the other medicines.
CE: Well, sometime next year there’s a chance for that to occur with a monotherapy indication. But from our standpoint, promotionally, with physicians and diabetes educators, we need to speak on-label with the FDA-approved label. So, Byetta works in monotherapy and it’s safe, however for now we’re not indicated and we’re used adjunctively.
SK: I think last year Byetta was selling so well that people couldn’t get enough of it?
CE: We were selling more than we could make - people say that’s a good problem to have. Well, it’s really not. It’s not helpful for the patients, the physicians.
SK: Especially if they’ve started asking for it.
CE: We notified physicians early enough to ask them hold off on initiating new therapy, but we never ran out of the drug for existing patients. So, we were watching the projections and selling a tremendous amount every month - to the point that we were the fourth most often-prescribed branded drug for diabetes. All this in Byetta’s first year on the market.
SK: The fourth most?
CE: The fourth most-prescribed branded product for type 2 diabetes, after the two TZDs [Actos and Avandia] and Lantus. Byetta had that position last summer when we were really on a rocket. We had physicians on hold until we could get an additional supplier to make more. Obviously we have plenty of Byetta now for current and new patients.
SK: Now, Craig, with the recent news about Avandia being not so good, have you seen an uptick in Byetta usage?
CE: We’ve seen an increase, but Byetta’s usage really is for that patient who’s been on a couple of oral medications - usually metformin because it works and it’s generic - and who then progresses to either a TZD or sulfonerya. At that point, a physician has a decision: Does he initiate insulin sooner? Does he start the patient on Byetta? Does he add on a third oral agent? It’s an art, not a science, and everyone has different approaches, but there are certain obvious benefits for certain patient types with Byetta.
SK: It comes in a pen, so you have to take an injection. And I’m hearing that because of the effect, people don’t mind taking the shot. We used to think that nobody liked injections, but I’ve heard that your product is showing that people don’t mind.
CE: Well, you just have to have people take the product. Since it’s injected with a 28- or 31-gauge needle, you can tell people that they won’t feel it but they never believe that. When they actually do it they’re amazed that they don’t feel it, especially if they’re injecting it into their abdomen or their leg. It’s painless and you inject twice a day with your major meals. The thing is, whether you’re 100 pounds or 400 pounds it’s the same dose, so you don’t need to titrate based upon body weight, age, sex, amount of food you’ve consumed. It’s the same dose because once your blood sugar gets to a normal level, Byetta stops working. So it’s hormonal in nature, physiologic like our bodies are, and it has an opportunity to work but not drive you down into a hypoglycemic state.
SK: Byetta is very expensive if insurance doesn’t cover it.
CE: We’re doing everything we can to demonstrate its value to insurers. If patients can get better control, have tighter control and improve their A1c’s, that’s what every managed care plan wants to see happen because the cost of a patient with diabetes is several times higher than a non-diabetic. At this stage we still have to prove the benefits - health and economic - and that weight loss [associated with it] has been positive overall.
SK: Are you sponsoring some studies?
CE: We’re looking at some current retrospective studies of patients with other managed care companies who have been on therapy. You look at their overall diabetes medication, their overall hospital stays and their overall cost. It’s intuitive that if people lose weight they’re going to be healthier. And we just have to prove that and put our money where our mouth is in terms of pharmaceutical economic studies.
SK: Well, I’m really excited at what you’re doing. Thanks for coming on our show to talk about these two new products [the other product is Symlin, which is covered separately] that I just hear nothing but good things about.
CE: I enjoyed it.
SK: Thank you so much, Craig.
CE: Thank you, Scott.
Feb 1, 2008
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.