I am excited to launch this innovative drug. How much longer do I have to wait?
Bydureon
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Hey be nice to the new FDEs. They are the future.
It may not matter!
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.
It may not matter!
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.
:ODo you think this will have any effect on the fde positions? It was my understanding they were hired to sell byetta?
Sir,
Please consult Lilly Care in each and every matter regarding your going forward.
Regarding the lizard spit, well the folks in NW Washington had the last laugh. A big lizard laugh . Uh huh ah ah
There is a significant benefit in a once-weekly product vs. once-daily. That benefit is 6 shots for a needle-adverse, middle-aged person, set in their ways, aka the non-compliant patient.
The difference in the percentage points 1.5% to 1.3% is virtually negligible.
You are worried about nothing. A lot of doctors will love this! ALL patients will love this. Seriously.
If I were type 2, I'd be asking for it.
The difference in the percentage points 1.5% to 1.3% is virtually negligible.
You are worried about nothing. A lot of doctors will love this! ALL patients will love this. Seriously.
If I were type 2, I'd be asking for it.
You are nuts. Bydureon is toast. That needle is huge and it don't work as well? Good luck!
$pitting Gila
Bye, Bye Bydureon...we hardly knew thee! Who knew you'd make Effluent™ seem like a stunning commercial success...bwaah..BWAAH...BWAAH HAHH HAAH HAAAA!!!
Bye, Bye Bydureon...we hardly knew thee! Who knew you'd make Effluent™ seem like a stunning commercial success...bwaah..BWAAH...BWAAH HAHH HAAH HAAAA!!!
You are totally correct. If you have ever sold pharma, its all about convenience and side effects. Period. Ask the folks from Pfizer about Zpack. Its only one of countless examples. If the efficacy is anywhere near similar, the docs and the patients want the option of the least hastle.
You are totally correct. If you have ever sold pharma, its all about convenience and side effects. Period. Ask the folks from Pfizer about Zpack. Its only one of countless examples. If the efficacy is anywhere near similar, the docs and the patients want the option of the least hastle. Bydureon will OWN the market.