Reuters: Bydureon Falls Short of Victoza!

Oops! So sorry, Amylin!

http://www.reuters.com/article/2011/03/03/lilly-amylin-idUSN0310092420110303?feedType=RSS&feedName=rbssHealthcareNews&rpc=43

 

Amylin-Lilly Study Backfires
Mar. 3 2011 - 9:49 am | 0 views | 0 recommendations | 0 comments
By MATTHEW HERPER
A study of Eli Lilly and Amylin Pharmaceuticals’ experimental diabetes drug just fell short.

The study failed to show that Bydureon, a once-a-week diabetes shot, was as effective at lowering blood sugar as Victoza, a once-a-day drug from Novo Nordisk.

That result led to new doubts about Bydureon, which many analysts forecast could have sales of more than $1 billion but which is already facing a delay at the Food and Drug Administration.

Shares in Amylin dropped 25% to $11.30 in early morning trading, while shares of Eli Lilly were basically flat. Shares in partner Alkermes, which made a technology used to make Bydureon a once-weekly drug, fell 15% to $12.

Both Bydureon and Victoza are synthetic versions of the glucagon-like peptide-1, or GLP-1, which stimulates the body to use insulin to regulate blood sugar. GLP-1 drugs are appealing because they are less likely than insulin to cause low blood sugar, which can be dangerous. The drugs control blood sugar and may also help patients lose some weight.

Bydureon is a longer-acting version of Byetta, the first GLP-1 drug, which was based on a chemical in Gila monster spit that is similar to GLP-1. Byetta must be given twice a day; Victoza is given once daily, and has been gaining share.

The expectation of the new study was that patients who took the once-weekly Bydureon would control their blood sugar at least as well as those who took once-daily Victoza. That didn’t happen. Patients who took Victoza reduced hemoglobin A1C, a measure of blood sugar, by 1.5 pecentage points, compared to 1.3 percentage points from Bydureon.

In an emailed note to clients, Mark Schoenebaum at ISI Group called the news a downside surprise. On a conference call, he said that whatever estimates were being made for Byetta’s pricing and market share, this study means they would be pressured. It would be a “reasonable conclusion” for doctors to view Bydureon as less effective than Victoza.

Robert Hazlett, an analyst who covers Alkermes at BMO Capital Markets, wrote that the results “muddy Bydureon’s commercial appeal.”

Bydureon still has two marketing advantages. One is that it is injected less often. Outside of a clinical trial, patients may be more likely to forget their doses.

A second is that Bydureon caused less nausea than Victoza. Twenty percent of patients on Victoza had nausea, 11% had vomiting, and 13% had diarrhea. That compares to a 9% rate of nausea on Bydureon, a 4% rate of vomiting, and a 6% rate of diarrhea.

The GLP-1 space is getting highly competitive. GlaxoSmithKline has its own GLP-1 drug in late-stage trials, and Sanofi-Aventis has one that it plans to pair with its insulin pens. Eli Lilly is also developing another GLP-1 that is distinct from the Amylin products.

Bydureon still faces another hurdle at the FDA, which wants more data on whether it changes heart rhythms. Analysts largely expect that study to work out, although it has resulted in a significant FDA delay.

 

Too bad they could not strike a better balance between efficacy and safety. It happens even at the most carefully manipulated trials. A scenario with more wet farts (like Victoza) for a better A1C outcome would have been much preferred.

 

I seem to have entered a weird parrallel universe where I am starting to feel sorry for Lilly and Amylin.
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Thank God that's over- normal attitute returning to that bunch of has-beens and never weres.

 

We are so fucking lucky. We have a 1x a day glp-1 and our competitors keep dropping by the wayside. At least in the short term. If we can get an obesity indication or pre-diabetes before the others come out, we're going to kill it.

But this is Novo, so we'll probably come out with the needed indication in 6 years.

Byetta is playing dirty pool lately anyway - they can go hang.

 

lilly boy here.

This is a powerful tool for Novo to use if Bydureon ever does get approved, and only if it gets approved before other once weekly hit the market, judging by Lilly totally inept managment team, it probably will not.


Now for this drug in particular, this is great news, but if you understand GLP-1's the drug does not actually lower A1C's. It simply allows your body to lower A1C's based on the pancreatic functionality left, and other MoA's that in a normal person would naturally all work hand in hand to keep ones sugars in check. However these patients have diabetes, so whether its Bydureon or Victoza there is no active agent that is actually combating the Sugars in the body. Your built in mechanisms that you were born with does this, there is no insulin in these products.

What does that mean. That means these tests are good to market, but if a physician or endo takes the time to truly dig deep, he would ask, why did Victoza beat Bydureon?

I wonder what line is Corporate gonna say should be the answer. It is clear why Victoza beat Byetta. Byetta has to be injected twice a day, and does not cover nightime highs or Lunch time. Thus when looking at a A1C, these uncovered periods impacts the overall avg a patient is experienceing, and results in a higher a1C than Victoza that has a full days coverage. Easy answer,

But when looking at the difference with once weekly, There will be a answer, but for the most part, They work the same and the next head to head could show the exact opposite. The actually drug would work exactly the same in a patients body as far as MOA, now there may be some difference in how the body removes the agents etc. But each are GLP-1, thus if you know the MOA you do know that the effectiveness of the drug is based on each individual patients remaining Pancreatic functionality, that is why many endo's pull a cpeptide test to see if GLP-ones would work any way.

So as your out there marketing this great news for Victoza, be prepared if a Endo wants to go deeper than the headlines and challenges the results.

Now with that being said, Victoza beat Bydureon and this can not be disputed. Regardless of anything, you all will have that fact. I think before you can have marketing pieces their has to be 2 tests or something like that at least that is what Lilly tells us the FDA requires. I beat Novo managment will have a marketing tools showing you all beat Byetta and Bydureon in two weeks...lol That is how aggressive your managment team is versus ours.

It is definately something if I worked for Novo i would make sure all of my doctor knew it, and leveraged Victoza more and more and more,,so that if Bydureon came out and had that same horrible delivery method, this head to head and the delivery method and the fact that Lilly has yet to outline what should a patient do if they came down with pancreatitus day 1-2-3-4...what should a patient do, since this will be in their body for a week.

No i dont work for the diabetes division anymore, so Yes i would definately be stating this to my endo's. Only thing is, that will be the question too for you to answer when your once a week comes out, as the pancreatitus issue is with all glp-1's.

I am glad in not selling Byetta or hoping to sell Bydureon. This drug just keeps getting bad news..

 

Shat the fuck up Lillyboy and jump off our dicks. We are done with you and your weak ass commentary. Go sell some whateva the fuck you are selling now and get on your competitors board. Your shit is old news.

 

shut the F up weak ass chat room toughie... I will get on any board at any time i want to..You dont like it, dont read it.

 

I'm sure you've just quoted Lilly's line perfectly in the excuse they will make up. However, they should be careful (as you should) in saying that Bydureon and Victoza are both GLP-1s. Victoza is a human GLP-1 analog, Bydureon is a GLP-1 mimetic. Perhaps, as we've said all along, the similarity to human GLP-1 with Victoza actually matters. That's a crazy thought, huh?

 

Victoza may have an advantage over Bydureon, but it has nothing whatsoever to do with etiher one being more or less human. The sequence is one thing, but what about the fatty acid attachment of Victoza ? it has no resemblence to anything seen for a circulating human peptide at so high concentrations. Try some other explanation.

 

So, it must just be an accident, huh?

 

Exenetide is an inferior molecule to liraglutide, just making it last longer will not change that fact clinically or physiologically.

 

It is clear you need to study up, as mimetic or human, it is about the MOA and how much Pancreatic functionality is left to execute what the drugs are telling the body to do. If you all do not understand that, then wow......

As for the company line, i do not know what the line is, as I am not in diabetes anymore, but anyone who has sold or does sell these drugs and understands how these drugs work, realizes certain facts.

Now for safety or how the drugs are removed from the system etc, you may have a point, but simply controlling sugars, your drug and our drug simply signal certain parts of the body that use to work for that person or works in people with out diabetes , it signals these parts to work again, based on how bad their diabetes is, or how close they are to being insulin dependent (hence C-peptide test) is generally how efficient these drugs will be. You will start to see a tail on these drugs in efficacy as the pancrease fizzles out. The drug itself does not directly lower sugars, it signals the body functions to do this for you.

Anything else I can educate you on.....

 

So, by your argument, the only way Victoza could have shown superior efficacy is that the patients RANDOMIZED to Victoza had more exisiting pancreatic Beta cell function than the ones on Bydureon. Is that really your line? If you'd like to educate me on something, educate me on how exactly that happens. Also, while you're at it--why don't you tell me every system and organ that GLP-1 affects and how each one affects overall blood glucose.

To pretend you (or anyone else for that matter) have a complete and thorough understanding of the incretin system and the various ways in which it maintains euglycemia is a bit pompous, don't you think? The FACT remains this: Victoza showed superior efficacy to Bydureon. Here's another FACT: there's a REASON it showed better efficacy (and it's not by accident, dumb shit--that's why they have p-values in studies, remember?)

Just as a reminder to you--you were to one who told us Bydureon would be approved already remember? All you've done is get on our site, pretend to know everything, and continually be wrong.

 

none of this matters because people cant afford it anyway.

 

Seems like I hit your sensitive funny bone. Hilarious that a chat room post can get to you, if your a man, then your weak..grow some balls, if your a woman, then get some dick real quick and get over it....K

I have been polite and professional with you all, and this is not YOUR BOARD as some try to say,,,it is a open forum, where anyone can post. So save that BS right there too.

As for the arguement that is posted here, so if I am wrong (which I am not) then tell us all, what MOA leads the superior efficacy? Please do. Also, I already stated, and will repeat, In a head to head you all have this data to run with, and I would too if I was you. The content was aimed at WHY? I would love to see you all produce a reason to show Why. Maybe the Once a week tapers off towards the end, thus it actually does not provide adequate control for a full week, thus could me more like 5 days etc. Who knows, but the fact is, if your dumbass...study's the MOA of both drugs it is clear as day that the DRUG does not directly lower sugars. If you do not know this then, i would love to get back in the Diabetes arena and compete with your dumb as$. The drugs again to help you not sound like a idiot in front of your doctors merely allows the body to control the sugars, there is no insulin in these drugs that is why you have minimal risk of Hypoglycemia.

The key difference in the two drugs is in safety and how they are execreted, etc. GLP-1 whether mimetic or human have the same MOA. Get it.

As for me telling it would be approved. Haha. I also told you all months before your drug would get delayed the first time that would happen too, so that makes me batting .500. Thats pretty good. But if you want to take it a step further. Mr or MRs novo idiot. I have made a career in pharma at eating up Novo reps, leading on rep to get kicked out of a major office for flat out lying to the office about the pens, etc and turnover that was not due to promotion if you know what i mean.. I would love to get back in it if this is the level of intelligence that you all are showing (not even understanding the MOA;s, trying so dayumm hard to differentiate, that you dont even understand the basics).

Now super rep...i could point out issues with your own study that shows a dramatic drop off in efficacy at the 78 week point vs Byetta that actually improved in your own study...I could also point out that in this most recent head to head at only 1.8 did your drug best Bydureon, not at the other dosage amounts. I wonder what dosage amount does most patients get. We are talking about 1.5 vs 1.3.... did you bother to look at the GI issues..was Victoza's double that of Bydureon...Finally didnt your once weekly get set back til mid 2012 to even be looked at? I would love to get back in this arena..As I would totally eat you alive, coming with that weak line. You better study everything before debating me. I am not even in diabetes anymore and would eat that up..... I wonder with your head to head data now..how is Victoza doing after almost a year on the market vs Byetta has it taken over the lead....Hmmm lets look.


Here is 2/18 IMS data...Before I post it..I bet I get a lot of IMS data is not counting Victoza scripts this and that.. BS here is the IMS data super rep.

18-Feb-11 30,721 11,464 (1.79%) (2.56%) 19,257 (1.33% Byetta.

18-Feb-11 23,195 9,869 (1.60%) 0.36% 13,326 (3.00%) Victoza.


Hmm judging by this, Amylin and Lilly are still doing just fine. There is no way in hell a twice a day drug that does not cover noon time highs or nightime issues for patient with diabets would compete effectively against me if I had a one shot a day. Unless I could not overcome one objective. Let me help you Novo reps.....If you cant sell this drug better vs Byetta then you are simply marketers... This is horrible for you all. Damm near 1 year later, after all this hoopla you was running around with, and Byetta is still whipping you all's as$. Please there is no need for once a week, Lily and Amylin still winning with their twice a day. Hell they should do like Steve Jobs and wait til you all FINALLY over come us, then get it approved. This could all be a set up, as there is no need to have once weekly out based on you all dismal performance with NRX and TRX. Sure your growing, but based on all the big talk you all was kicking around, your bite does not near meet your bark.

Learn the drug, learn how to sell, and overcome objections. Beating you all was like Junior High school work, and it still seems to be the same for most lilly and amylin reps judging by ImS DaTA...

Finally you said Continually wrong..... sounds like your jealous, and delisional. Continually means more than once. I was wrong about it being approved. Ok I am not Nostradamous, but I was right about your drug being delayed. What else was I wrong about. Nice eating you up again, learn the facts.

 

I've never met anyone that didn't have a sensitive funny bone. Mine hurts like a mothafucker when I hit it.

 

Bydureon might be less efficacious 1.3% vs. 1.5 I believe, you got that going for you and I'm sure the Polish wizard will run with that. But Bydureon won't cause a patient to worry about cancerous tumors.

I'd sacrifice .2 A1c reduction if I risked cancer. Besides Januvia reduces A1c by what .6% and it's a blockbuster drug.

I'm just saying Novo sucks.

And to LillyBoys point. Perhaps Bydureon doesn't produce a high enough clinical effect for 7 days. Maybe it drops off before it should. We know all about that....Levemir can't provide adequate effect for 24 hrs. You know it, I know it. Most expensive BID insulin on the market.

 

That was a lot of writing to ever answer the questions that I posed to you. And, last time I checked, you're the ONLY one on this board claiming to be "super rep"--tell me again how you ate your Novo rep for lunch. I love that story. I like a good laugh.

As for your batting average, you told us Bydureon was going to be approved about 600 times. That's 0 for 600 for you, smart ass.

Thanks for showing that you can cite a lot of data, but still have nothing in the end except for a product with inferior efficacy. Now, go ahead and write another 11 paragraphs that no one will read.

 

Dude, give it up. No one is listening to you. No one ever has. You're pathetic.