During the boceprevir review on Tuesday I heard phrases like “complicated label” and “underpowered” or "not really there" (relating to data for 24 week treatment duration for partial responders and relapsers). [All from FDA Advisory Panel members.]
During the telaprevir review on Wednesday I heard phrases like “complete and easy to understand” relating to trial design and results. I also heard phrases like “need for education” related to the amelioration of the rash side effect.
There is little that can be done (except for perhaps prayer) to make up for Schering-Plough/Merck’s flawed clinical trial design which will likely lead to a complicated label.
[Conversely,] there is much that can be done about educating physicians and patients in the management of rash during the use of telaprevir (indeed that has been done since telaprevir’s P3 dropout rate was 0.8%).
Bottom line – Vertex is better poised with more than a year’s supply of telaprevir stockpiled to sweep up the population of patients previously treated with SOC. Their label will indicate either a 24 week therapy (for partial responders/relapsers) or potentially longer therapy (for null responders). These are the patients that have been sitting on the sideline watching and waiting, following the story closely. These are people who have already experienced the side effects of SOC. I think for the most part that they will opt for telaprevir’s 24 week therapy now instead of waiting for Merck to get a label change later for a less than 48 week therapy.
I also don’t think reimbursement for erythroprotein will be clear-cut, which is a further potential liability that could appear on boceprevir’s label. So yes, Merck might have an advantage in terms of having a well developed marketing capability. They will need it to grab the 20% of the early Hep C market that will come their way under their most optimistic scenario. I think it will be more like 10-15%. Again, much will depend on the label
During the telaprevir review on Wednesday I heard phrases like “complete and easy to understand” relating to trial design and results. I also heard phrases like “need for education” related to the amelioration of the rash side effect.
There is little that can be done (except for perhaps prayer) to make up for Schering-Plough/Merck’s flawed clinical trial design which will likely lead to a complicated label.
[Conversely,] there is much that can be done about educating physicians and patients in the management of rash during the use of telaprevir (indeed that has been done since telaprevir’s P3 dropout rate was 0.8%).
Bottom line – Vertex is better poised with more than a year’s supply of telaprevir stockpiled to sweep up the population of patients previously treated with SOC. Their label will indicate either a 24 week therapy (for partial responders/relapsers) or potentially longer therapy (for null responders). These are the patients that have been sitting on the sideline watching and waiting, following the story closely. These are people who have already experienced the side effects of SOC. I think for the most part that they will opt for telaprevir’s 24 week therapy now instead of waiting for Merck to get a label change later for a less than 48 week therapy.
I also don’t think reimbursement for erythroprotein will be clear-cut, which is a further potential liability that could appear on boceprevir’s label. So yes, Merck might have an advantage in terms of having a well developed marketing capability. They will need it to grab the 20% of the early Hep C market that will come their way under their most optimistic scenario. I think it will be more like 10-15%. Again, much will depend on the label
I'm perfectly happy to watch you flounder when investors begin to shift their money away from Vertex in the near future to other companies that have the above said drugs in their pipelines. This already started at the end of February (and really late summer last year), but I doubt you are smart enough to have seen the inversely proportional changes in the stock price of competitive companies vs VRTX. Money went straight out of VRTX and into the future competition. Sure VRTX is making a nice run in the market now and will in the near future but the point is, it will be short lived. Your HCV pipeline can't match what is coming down the road. Period.