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Replies to post #115811 on Biotech Values
03/03/11 1:22 PM
“We didn’t hit the primary endpoint, but the results do actually reinforce the fact that this product has a very robust effect,” Amylin Chief Executive Officer Dan Bradbury said in a telephone interview today.
03/03/11 1:37 PM
Q: Novo Nordisk also has a once-weekly version of Victoza in development; What do you think about the potential of this product?
A: It still escapes me whether there is a compliance benefit by being once weekly as opposed to being once daily. I have a hunch that the compliance will be worse in fact, because it is easier to do something once a day then to remember did I do it on Sunday? And you can't do it twice because if you did take a big dose on Sunday then you are going to get very nauseated. Then there is another, more subtle, aspect, which is this notion of should you really tell people that they only need to worry about their diabetes on Sundays.
… but then we got the impression from the regulators that they were a little bit concerned about considering to go to such a regimen so that also built on my notion. The reason we are talking about once weekly is a competitive issue rather than a compliance issue….For defensive reasons we're going to develop it. We don't want to get caught flat-footed.
Q: Amylin plans to release data from a head-to-head trial comparing Bydureon to Victoza later this year. What impact might this study have?
A: If you made a statistical analysis of head-to-head studies you would find that the one that initiates the trial more often than not wins the trial. You can only get a certain maximum level of blood glucose control on the GLP-1 receptor and we have achieved that with Victoza. We should get the same blood glucose lowering effect [in the study] -- if they dose Victoza high enough to get that effect. If they are not doing that then, of course, we can get a different result. On the side-effect parameters, there might be differences.
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