Boceceprevir

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If Merck screams out of the gate, it will hit 1 billion in 2012. However, the future 3-4 years doesn't seem so bright for Merck since the next generation therapies seems to not require Pegylated Interferon and might be preferred over boceprevir. US approval to sell ought to be around June 1.
 


















Anonymous said:
If Merck screams out of the gate, it will hit 1 billion in 2012. However, the future 3-4 years doesn't seem so bright for Merck since the next generation therapies seems to not require Pegylated Interferon and might be preferred over boceprevir. US approval to sell ought to be around June 1.
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Guess you don't know our pipeline? HMMMM
 


















Anonymous said:
Any progess of getting this drug approved?
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FDA Panel decision in one week. Unless there are issues (issues that ought to already be known to Mighty Mother Merck) it is still possible to start sales in US by June 1. Is it even remotely possible that the US sales force is not already in-place and trained? Merck can use some positive news. Any delay on boceprevir would be taken very badly by the investment community. Any delay relative to telaprevir would be a kick in the teeth.
 






Anonymous said:
FDA Panel decision in one week. Unless there are issues (issues that ought to already be known to Mighty Mother Merck) it is still possible to start sales in US by June 1. Is it even remotely possible that the US sales force is not already in-place and trained? Merck can use some positive news. Any delay on boceprevir would be taken very badly by the investment community. Any delay relative to telaprevir would be a kick in the teeth.
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Looks like FDA will ask some questions on anemia for boceprevir tomorrow and does not have any special questions for telaprevir on Thursday. Both are likely to be recommended for approval but there may be some negative comments for one or both that could end up being resolved by labeling.
 






Wow....no FDA comments?!? Yes...got approved but this label will be a nightmare. The panel recommended 37 follow up studies to do!!!!! Very disappointed in lack of DDI info and looks like no approval for nulls. Looks like longer treatment to for blacks and late responders. Looks like the work has ended...it's just beginning!!!!
 






Anonymous said:
Wow....no FDA comments?!? Yes...got approved but this label will be a nightmare. The panel recommended 37 follow up studies to do!!!!! Very disappointed in lack of DDI info and looks like no approval for nulls. Looks like longer treatment to for blacks and late responders. Looks like the work has ended...it's just beginning!!!!
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Hello nail, my name is coffin.
 






Followed the real-time blog on and off and I would not draw the same conclusions. Remember that this is a panel with largely go-no go review charter. It will get approved and probably in about the same time frame as telaprevir. It is the getting approved that is the hurdle. Merck is well-aware of the label issues prior to the panel meeting and they will have several options for this situation. I don't think that the outcome from today's review will differ in impact much more than the clinical differences which favor Vertex but are not powerful enough to exclude Merck from the game.
 






Anonymous said:
Followed the real-time blog on and off and I would not draw the same conclusions. Remember that this is a panel with largely go-no go review charter. It will get approved and probably in about the same time frame as telaprevir. It is the getting approved that is the hurdle. Merck is well-aware of the label issues prior to the panel meeting and they will have several options for this situation. I don't think that the outcome from today's review will differ in impact much more than the clinical differences which favor Vertex but are not powerful enough to exclude Merck from the game.
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If you really watched the blog, Adam said that the drug will get approved but label may not be ready by May 7 date based on what the panel was recommending. I read the blog and watched the whole presentation as well...I was embarrassed on how we handled the nulls...very arrogant. The panel even mentioned how shocked they were on how Merck made assumptions with nulls in gaining approval.
 






Merck is targeting victory with product approval. If they paralleled Vertex, their program wouldn't be ready until late this year. They will try to work the system to expand patient population from basic approval. Vertex won't be without its issues, either.
 






Anonymous said:
Merck is targeting victory with product approval. If they paralleled Vertex, their program wouldn't be ready until late this year. They will try to work the system to expand patient population from basic approval. Vertex won't be without its issues, either.
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Vertex still expected to have 70-80% of the market.
 












Anonymous said:
Not since doctors have begin to hear about the rash issue......Gi's are afraid of rash. Don't need the hassle.
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this is exactly right. most docs would actually prefer anemia management over severe rash because they keep patients on/complete treatment. rash patients will have to stop treatment and start all over again.
 






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