Replies to post #117099 on Biotech Values

[DewDiligence]

Telaprevir and Boceprevir are being sold in France for $31K per treatment course, under a pre-EU-approval “compassionate use” program:

http://www.bloomberg.com/news/2011-04-03/merck-j-j-s-new-hepatitis-c-treatments-fetch-31-000-in-france.html

The US prices, which have yet to be announced, will almost certainly be higher. The UK’s NICE says that reimbursement may be restricted to the second-line setting and/or selected IL-28B variants.

[DewDiligence]

Telaprevir SVR Data by IL28B Status

Although SVR rates varied strongly according to IL28B status, Telaprevir+SoC was much better than SoC alone in all IL28B variants in the ADVANCE (first-line) and REALIZE (second-line—scan down for table) phase-3 studies.

SVR/EVR/RVR by IL28B status in ADVANCE study:




SVR by IL28B status in REALIZE study:



Source: http://finance.yahoo.com/news/Data-From-Phase-3-Studies-bw-2567396588.html?x=0&.v=1

[DewDiligence]

MRK hasn’t reported phase-3 SVR data for Boceprevir stratified by IL28B status (to my knowledge); rather, they reported treatment response at 8 weeks:

http://finance.yahoo.com/news/New-Data-Analyses-with-bw-2179245112.html?x=0&.v=1

In pre-specified analyses of the pivotal Phase III studies, …researchers found that IL28B status (CC, CT or TT) was a strong baseline predictor of viral response at treatment week 4, week 8 and SVR among patients receiving VICTRELIS. Among those carrying the CC gene allele, 89 percent of treatment-naïve patients and 82 percent of treatment-failure patients had an early response, defined by undetectable virus (HCV-RNA) at treatment week 8, and were eligible for a shorter duration of therapy. Among those with the less favorable gene allele (CT or TT), 52 percent of treatment-naïve patients and 48 percent of treatment-failure patients had an early response and were eligible for a shorter duration of therapy. The analyses also showed that response after the 4-week lead-in was a stronger predictor of SVR than any single baseline variable, including IL28B status.

The analyses included data from 63 percent of patients (912/1442) in the pivotal Phase III studies who received at least one dose of VICTRELIS or standard therapy and consented to genomic analysis to test for IL28B polymorphisms. In total, 28 percent of tested patients carried the CC allele, while 54 percent carried the CT allele and 18 percent carried TT.