Friday, April 29, 2011

Now, "It's All About The Label": Vertex's Telaprevir Has A Clear, Easy FDA Label Path

I just saw a great comment, by Iron2_2000 -- over on the Yahoo stock chatboard, on this very topic -- thus:

. . . .I see only one complicated label forthcoming [Merck's Boceprevir].

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. . . .

On Wednesday, the FDA Advisory Panel, voting 18-0, absolutely gushed about how well-designed, and executed, Vertex's clinical data appeared. That alone will make for clearer and easier label copy, after FDA vetting (when compared to legacy Schering-Plough's ill-designed trials, which have now led to complicated, confusing labeling). It's all in doing the "little things" right (and doing so, every time), guys.

In passing, I'll note that Merck posted good results this morning, nominally beating, while taking the $500 million J&J charge (among other ongoing write-downs) -- so it is hard to tell whether it was all a pure fundamental sales and gross margin beat -- or, in part, some financially engineered upside, by moving ongoing expense numbers into one-time charge buckets. Unfortunately, I don't have time today, to sort it all out, line by line -- will do so over the weekend. Be excellent to one another.


Anonymous said...

The necessity to use EPO in many boceprevir treated patients not only complicates the therapy but significantly and unnecessarily increases the cost of therapy. In most Western countries, majority of HCV is treated by community-based gastroenterologists which do not typically use EPO in their clinical practice.

One must also remember that the use of EPO to control boceprevir and/or ribavirin-induced anemia is an OFF LABEL use of EPO (the last time I looked) which further complicates both access and treatment. I suspect most community-based physicians would be reluctant to undertake this liability especially given the likely availability of telaprevir which is not plagued with this issue.

Barring a catastrophic event or major Vertex blunder, its looking more and more likely that Vertex will emerge the winner post-commercialization.


condor said...

Excellent, my friend -- and welcome back from the land of the lurkers! I've made yours a new post, above!