SK: We’re joined on our show by Craig Eberhard, vice presidentof 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 whoare pre-diabetic. Craig, it seems that you have a huge market for this. Let’stalk about who it’s indicated for.
CE: Byetta is indicated for patients with type 2 diabetes whohave 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 oralmedications.
SK: OK, let’s stop there. Why not? Why shouldn’t a new type 2who’s overweight take your product?
CE: Well, we’re doing studies and actually have submitted themto the FDA forum on monotherapy. The initial indication and studies on Byettawere for adjunctive therapy. A typical patient’s going to go on metformin orsome other form of oral therapy, and then progress to a number of orals and theneventually to insulin. So, Byetta is indicated prior to insulin and there aresome definite advantages to it not only in terms of glucose control but weightbenefits for most patients. And it’s a single dose – you don’t have to titrateand 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, isthat like somebody decides the order that these drugs are going to be prescribedin? 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 whereByetta has been utilized, you see a medication that controls your blood sugarbut can also help you maintain – or in most patients, lose weight – that’sbeneficial. As you know, with many oral medications, and certainly insulin, youcan have weight gain associated with your usage of the product. Byetta has somesort of satiety or neuro-hormonal effect where you eat less, so it’s nothingmore 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 takethis 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 occurwith a monotherapy indication. But from our standpoint, promotionally, withphysicians and diabetes educators, we need to speak on-label with theFDA-approved label. So, Byetta works in monotherapy and it’s safe, however fornow we’re not indicated and we’re used adjunctively.
SK: I think last year Byetta was selling so well that peoplecouldn’t get enough of it?
CE: We were selling more than we could make – people say that’s agood 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 oninitiating new therapy, but we never ran out of the drug for existing patients.So, we were watching the projections and selling a tremendous amount everymonth – to the point that we were the fourth most often-prescribed branded drugfor diabetes. All this in Byetta’s first year on the market.
SK: The fourth most?
CE: The fourth most-prescribed branded product for type 2diabetes, after the two TZDs [Actos and Avandia] and Lantus. Byetta had thatposition last summer when we were really on a rocket. We had physicians on holduntil we could get an additional supplier to make more. Obviously we have plentyof Byetta now for current and new patients.
SK: Now, Craig, with the recent news about Avandia being not sogood, have you seen an uptick in Byetta usage?
CE: We’ve seen an increase, but Byetta’s usage really is forthat patient who’s been on a couple of oral medications – usually metforminbecause it works and it’s generic – and who then progresses to either a TZD orsulfonerya. At that point, a physician has a decision: Does he initiate insulinsooner? 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 arecertain obvious benefits for certain patient types with Byetta.
SK: It comes in a pen, so you have to take an injection. AndI’m hearing that because of the effect, people don’t mind taking the shot. Weused to think that nobody liked injections, but I’ve heard that your product isshowing that people don’t mind.
CE: Well, you just have to have people take the product. Sinceit’s injected with a 28- or 31-gauge needle, you can tell people that they won’tfeel it but they never believe that. When they actually do it they’re amazedthat they don’t feel it, especially if they’re injecting it into their abdomenor 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 youdon’t need to titrate based upon body weight, age, sex, amount of food you’veconsumed. It’s the same dose because once your blood sugar gets to a normallevel, Byetta stops working. So it’s hormonal in nature, physiologic like ourbodies are, and it has an opportunity to work but not drive you down into ahypoglycemic state.
SK: Byetta is very expensive if insurance doesn’t cover it.
CE: We’re doing everything we can to demonstrate its value toinsurers. If patients can get better control, have tighter control and improvetheir A1c’s, that’s what every managed care plan wants to see happen because thecost of a patient with diabetes is several times higher than a non-diabetic. Atthis stage we still have to prove the benefits – health and economic – and thatweight loss [associated with it] has been positive overall.
SK: Are you sponsoring some studies?
CE: We’re looking at some current retrospective studies ofpatients with other managed care companies who have been on therapy. You look attheir overall diabetes medication, their overall hospital stays and theiroverall cost. It’s intuitive that if people lose weight they’re going to behealthier. And we just have to prove that and put our money where our mouth isin terms of pharmaceutical economic studies.
SK: Well, I’m really excited at what you’re doing. Thanks forcoming on our show to talk about these two new products [the other product isSymlin, which is covered separately] that I just hear nothing but good thingsabout.
CE: I enjoyed it.
SK: Thank you so much, Craig.
CE: Thank you, Scott.