Replies to post #60338 on Biotech Values

[microcapfun]

VRTX Begins Phase-3 Telaprevir Trial

Let's say this telaprevir + peg IFN trial is successful - and also assume the genotype 1 HGS Albuferon trial is successful as well. In this case, Albuferon would almost surely be approved before telaprevir, so let's assume that as well.

With these fairly reasonable assumptions - will the FDA approve telaprevir ...

(i) only in combination with pegylated interferon and ribavirin

or

(ii) in combination with either any approved IFN-alpha and ribavirin ?

[Remember - thus far no trial of telaprevir + Albuferon has even begun ... not even a Phase 1 trial.]

If (i), then Albuferon could only be used with telaprevir off-label, and reimbursement might well be an issue. Obviously that could hurt Albuferon sales.

I have my own opinion regarding (i) vs (ii), but I'd like to hear from others - particularly Dew.

micro

[genisi]

VRTX to begin a new phase III study (REALIZE) of telaprevir in HCV treatment failures (it will enroll null responders, partial responders and relapsers).
Telaprevir dose - 750mg, q8h, for 12 weeks + 36 weeks.


http://investors.vrtx.com/releasedetail.cfm?ReleaseID=328603