Biotech Values

[DewDiligence]

Re: Albuferon and the Telaprevir label

>I was thinking the former, i.e. that [FDA] would require a telaprevir/Albuferon trial to obtain FDA approval for that combination.<

Perhaps I should have qualified my answer by saying it presupposes an elapsed time of about a year between the two approvals. If the two approvals were to be more closely spaced than that, the narrow Telaprevir label that you expect (excluding use with Albuferon) might make sense.

However, if there is a year or more of elapsed time between the approvals and if Albuferon has been launched with no serious mishaps during that period, then I don’t think the FDA would effectively derail Albuferon’s continued uptake by issuing a Telaprevir label that excluded Albuferon explicitly or implicitly.

In the meantime, it would be worthwhile for HGSI to ask VRTX for enough Telaprevir to conduct drug-drug interaction studies in the replicon and animal models and to present the data from these studies to the FDA. There is no a priori reason I know of to expect a problem with such a drug combination.

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The Avastin precedent in first-line mCRC

>5FU has many years of experience behind it. I presume that there is very little difference between the different "varieties" of 5FU. It is not so clear that the *new* drug Albuferon would combine with the *new* drug telaprevir the same way that Pegasys combines with telaprevir ... as determined by a Phase 3 clinical trial.<

The issue is not the various forms of 5FU but rather the chemo drug used with 5FU. In giving Avastin a broad label that included any 5FU-based chemo regimen, the key word was based, which implicitly expanded Avastin’s label to FOLFOX regimens as well as FOLFIRI regimens despite the fact that there were no clinical data from a randomized controlled trial showing that Avastin offered a clinical benefit in first-line mCRC (the original approval setting) when combined with FOLFOX.

Thus, I think the Avastin precedent is a good one for the Telaprevir/Albuferon case.

Finally, you have cleverly omitted mention about what will become of Peg-Intron in the Telaprevir label. You said you expected the label to be restricted to Pegasys but surely you don’t mean that inasmuch as Pegasys and Peg-Intron are considered by many clinicians to be interchangeable. Perhaps the need for the FDA to include Peg-Intron implicitly in the Telaprevir label will lead to a vaguely worded label that includes any weekly or biweekly interferon in much the same way that the original Avastin label was vaguely worded to implicitly include FOLFOX.