Biotech Values

[tinkershaw]

<<<A possible reason they may not: Doctors would prescribe the regime for treatment-naive patients, already knowing the efficacy blasts SoC.>>>

Which is no reason not to approve the drug for second line. What you are going to end up having is more patients in need of second line treatment, that would not have needed second line treatment, had they been treated with telaprevir to begin with.

This is one of those logically absurd situations that screams out for the FDA sticking to its mandate of (1) does it work as indicated, (2) is it reasonably safe. Yes, yes, and we can say both with a very high degree of confidence in both the first and second line setting. This is not a provenge where the efficacy data is ambiguous. This is an in your face, the drug works, the drug works very well, the drug is reasonably safe, so lets get it out there and let the phase III continue as a de-facto phase IV post marketing study.

Makes too much sense, I'm sure this to be the inevitable result. It is situations like this where the FDA has to lighten up, and free up some resources to deal with the more problematic issues for more problematic drugs.

The FDA of the last two years however will not allow a filing on the Prove 3. The FDA prior to this, okay maybe going back a little further to pre-Vioxx, would have allowed just this result.

The good thing with VRTX is even if you don't feel lucky, you may just have to wait another year to get satisfaction, and being satisfied earlier would be a nice upside surprise.

I see peak telaprevir sales of up to $3.5 billion a year. I would put the range on a low end of $1.5 billion to a high end of $3.5 billion. VRTX obviously feels the threat of future generations of interferon free treatment options such as Roche is attempting with ITMN-191. VRTX felt it strongly enough that they went out and made a speculative acquisition to acquire their own potential non-interferon cocktail drug additions that may or may not actually work as they would like. Indicating that VRTX does not presently have such a capacity in house either. So there is risk down the road, maybe 5 years or so with this new cocktail. But from here to there at 6x $1.5 billion you get about a double from here. At 6x $3.5 billion a triple to quadruple or thereabouts. Good upside, limited downside (assuming some unforseen catastrophe does not strike telaprevir). In biotech, that is rather "risk-adverse" as things go.

No, it does not presently have the potential upside of say a MNTA. But MNTA is a crapshoot in regard to how many generics are approved. We really have no way of knowing. We just hope. VRTX does not have any large follow-up programs yet. It has a drug that has performed well in a very limited market with cystic fibrosis, that maybe can be expanded into a larger market. Whereas MNTA does have other potential blockbusters at present. But that would be my only concern for VRTX at present. But from here to there is a long way.

Anyways, that is my take on the present issue. The old FDA approves it second line and uses the on-going phase III as essentially a post-marketing study. The new FDA leans towards waiting for all the data to come in, even if we pretty much know what it is.

Did I forget to mention boceprevir? Sorry. Schering (who just bought them, sorry I forgot) is a much better marketing and sales company, they can try to bundle boceprevir, play with reimbursements etc to take marketshare, but head to head, on an even playing field, even though the data is arguably very similar, I just don't see boceprevir being anything but a distant #2, absent some very creative and seriously successful marketing and sales campaign that deals with issues that get around the head to head issues, and plays more on reimbursement and bundling issues.

Anyone feel any different about this?

Tinker